Patient Safety Incidents in an Intensive Care Unit during the COVID‑19 Pandemic: A Retrospective Cohort Study

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This study aimed to analyze the occurrence of AEs, their characteristics, and associations with clinical outcomes and resource utilization among ICU patients. Methods: A retrospective observational cohort study was conducted in a private tertiary hospital in São Paulo, Brazil. Data from ICU admissions between March 2020 and July 2021 were analyzed. The study included patients ≥17 years old with a confirmed COVID-19 diagnosis. Data on demographics, clinical scores, AE occurrence, ICU outcomes, and device usage were collected and analyzed using descriptive statistics and appropriate inferential tests. Results: Among the 1,226 patients admitted to the ICU, 25.2% experienced at least one AE. Most patients were male (68.8%) with a mean age of 64.1 years. The ICU mortality rate was 19.1%, and the hospital mortality rate was 24.2%. Patients with AEs had a significantly longer ICU length of stay (mean 23.8 ± 22.3 vs. 9.8 ± 9.9 days), higher Charlson Comorbidity Index, Simplified Acute Physiology Score III and Sequential Organ Failure Assessment scores, and standardized mortality ratios (p < 0.001 for all comparisons). Most AEs involved harm (60.96%), primarily mild (86.5%), with skin/soft tissue injuries and device-related incidents being the most common categories. AE occurrence was significantly associated with increased use of invasive interventions, including mechanical ventilation (OR 6.71), vasopressors (OR 2.88), and central venous catheters (OR 4.25) . Conclusions: AE occurrence was frequent among ICU patients with COVID-19 and was significantly associated with longer ICU stays, higher mortality, and greater use of critical care resources. These findings underscore the importance of targeted strategies to reduce AEs in high-acuity settings. Trial registration: Not applicable. Patient Safety Intensive Care Units Health Information Systems Risk Management COVID‑19 Background Since the publication of To Err is Human: Building a Safer Health System by the Institute of Medicine in the early 2000s, a landmark in the global patient safety movement, there has been increasing attention to research and initiatives aimed at improving safety in healthcare settings. More than two decades later, preventable patient harm remains a critical concern, underscoring the persistent need to better understand the complexity of healthcare errors and to ensure the reliable and continuous monitoring of adverse events (AE) [ 1 ]. AE in healthcare often result from multifactorial causes, including the high volume of information flow, interdisciplinary team dynamics, the integration of new technologies, and the challenges of operating in complex and highly stimulating environments. While learning from errors and understanding their root causes are essential, implementing proactive safety barriers and preventive strategies to reduce the occurrence of AEs is equally important [ 2 ]. The development of such safety systems requires a high degree of organizational maturity. In Brazil, structural limitations such as shortages of trained professionals, prolonged wait times, resource constraints, and gaps in public health policy continue to pose significant challenges to the implementation of safe care practices [ 3 ]. These barriers were further intensified during the COVID-19 pandemic. Owing to its high transmission rate and initially undefined clinical protocols, COVID-19 has rapidly escalated into a global public health emergency. In response, hospitals are required to rapidly reorganize their operations, which include emergency staffing, expansion of intensive care unit (ICU) capacity, and procurement of essential resources such as personal protective equipment, disinfectants, critical medications, mechanical ventilators, and infusion pumps [ 4 ]. These demands exposed systemic vulnerabilities across healthcare services, particularly the absence of contingency planning, high costs of medical supplies, ICU overcrowding, and inefficiencies in operational workflows. Consequently, patient safety may have been compromised, contributing to an increased incidence of AE [ 5 ]. Given this context, the present study aimed to analyze patient safety incidents in an ICU during the COVID-19 pandemic and to evaluate their associations with patient outcomes. Methods Study Design and Setting This was a retrospective cohort study conducted in a private tertiary hospital in São Paulo, Brazil. The hospital has 350 beds and expanded its ICU capacity from 44 to 89 beds during the pandemic. The ICU was divided into seven COVID-19 units and four non-COVID-19 units. The design and reporting of the studies were guided by the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) guidelines. Population and Data Collection Data were collected from March 2020 to July 2021. The cohort included patients aged ≥ 17 years with a confirmed diagnosis of COVID-19 (positive RT-PCR). Patients were included in the AE group if they had at least one AE reported during their ICU stay. Data were extracted from clinical and epidemiological information systems and the hospital's safety incident reporting database. The variables included: date of the AE, number of AEs, type and severity of AE, patient age and sex, reason for hospital discharge, readmission within 30 days, ICU readmission, ICU outcome, ICU length of stay, Charlson Comorbidity Index, Simplified Acute Physiology Score 3 (SAPS 3), standardized mortality ratio, and Sequential Organ Failure Assessment (SOFA) score. Data analysis Descriptive statistics were used for categorical and numerical variables. Associations were analyzed via the chi-square test or Fisher's exact test for categorical variables and the t test, Mann‒Whitney test, or Shapiro‒Wilk test for continuous variables. Significance was set at p < 0.05. Ethical considerations The study was approved by the Institutional Research Ethics Committee (CAAE 51449121.8.0000.0070). Given the observational design, informed consent was waived. Data confidentiality was ensured. Results During the data collection period, a total of 1,226 ICU admissions were recorded, of which 68.76% were male. Among these admissions, 25.2% involved at least one AE during the ICU stay. In terms of hospital outcomes, 73.46% of patients were discharged in improved condition, whereas 24.16% died. With respect to ICU discharge status, 79.18% were transferred to a hospital ward, and 19.1% died during their ICU stay (Table 1 ). Table 1 Categorical variables describing the demographic characteristics of ICU patients (n = 1,226). Variable n (%) Adverse events during ICU* stay No 917 (74.8%) Yes 309 (25.2%) Sex Male 843 (68.76%) Female 383 (31.24%) Type of hospital admission Emergency 1,183 (96.49%) Elective 42 (3.43%) Workplace accident 1 (0.08%) Hospital discharge outcome Discharged (improved) 897 (73.87%) Death 295 (24.16%) Transferred to another hospital 24 (1.97%) ICU* outcome Discharged to hospital ward 970 (79.18%) Death 234 (19.1%) Transferred to another hospital 21 (1.71%) Hospital readmission within 30 days No 1,159 (94.54%) Yes 67 (5.46%) ICU* readmission No 1,136 (92.66%) Yes 90 (7.34%) *ICU = Intensive Care Unit Among the selected samples, the number of AE per patient ranged from zero to six. The mean patient age was 65 years, and the average length of stay in the ICU was 13 days (Table 2 ). Table 2 Numerical variables describing the demographic and clinical characteristics of ICU patients (n = 1,226) Variable Min–Max* Q1–Q3† Median Mean (SD‡) Number of adverse events 0–6 0–1 0 0.36 (0.73) Age (years) 17–100 53–76 65 64.06 (15.88) ICU length of stay (days)§ 1–257 4–17 9 13.32 (15.35) Charlson Comorbidity Index 0–12 0–2 1 1.20 (1.79) SAPS 3 score 24–111 45–58 50 51.91 (10.87) Standardized Mortality Ratio 0.73–95.21 10.93–31.50 17.35 23.12 (17.44) SOFA score¶ 0–15 1–4 2 2.84 (2.93) *Min–Max = Minimum and maximum values †Q1–Q3 = First and third quartiles ‡SD = Standard deviation §ICU = Intensive Care Unit ||SAPS = Simplified Acute Physiology Score ¶SOFA = Sequential Organ Failure Assessment The analysis of safety incidents was based on the hospital's internal incident reporting system. In total, during the study period, 438 safety incidents were reported, with the majority occurring during the night shift (47.03%), followed by 27.85% in the morning and 25.11% in the afternoon. Nurses were the professionals who reported the most incidents (73.52%). Regarding the type of incident, 60.96% were classified as incidents with harm. Among these, 86.52% were mild, 7.87% were moderate, 4.49% were severe, and 1.12% were sentinel events. Among all reported incidents, 27.75% were related to patient accidents, 27.29% to clinical procedures and processes, and 23.62% to medical devices. The most frequently reported incident categories were skin and soft tissue injuries (24.89%) and issues related to invasive and noninvasive devices (16.67%). To assess the impact of AE on ICU patients during hospitalization, we analyzed the associations between the study variables and the presence or absence of AEs in the ICU. Table 3 highlights the associations between ICU readmission and the occurrence of AEs, as well as a higher rate of events among patients whose outcome was death. Table 3 Association between categorical variables of hospitalized patients and adverse events (n = 1226). Variables AE – No AE – Yes p-value Sex 0.155 † (Cramér's V = 0.04) Female 297 (77.55%) 86 (22.45%) Male 620 (73.55%) 223 (26.45%) Hospital Discharge Outcome < 0.001 ‡ Discharged improved 726 (80.48%) 176 (19.51%) Death 172 (58.31%) 123 (41.69%) Hospital transfer 19 (79.17%) 5 (20.83%) ICU* Readmission < 0.001 † (Cramér's V = 0.12) No 866 (76.23%) 270 (23.77%) Yes 51 (56.67%) 39 (43.33%) ICU* Outcome < 0.001 † (Cramér's V = 0.18) Transfer to ward 763 (78.66%) 207 (21.34%) Death 138 (58.97%) 96 (41.03%) Hospital transfer 16 (76.19%) 5 (23.81%) *ICU = Intensive Care Unit † Chi-square test; ‡ Fisher's exact test An association was also observed between the clinical data collected at the time of ICU admission and the occurrence of AE. Table 4 presents the associations between AEs and length of stay in the ICU, the Charlson Comorbidity Index, the SAPS 3 score, the standardized mortality ratio based on the SAPS 3 score, and the SOFA score. Table 4 Association between numerical variables of hospitalized patients and adverse events (n = 1226). Variable AE No AE Yes P valor ‡‡ Min–Max* Q1–Q3† Median Mean (SD‡) Min–Max* Q1–Q3† Median Mean (SD‡) Age (years) 17–100 52–75 63 63.35 (16.09) 23–96 57–77 67 66.14 (15.09) 0.003 ( r: -0.09) ICU Length of Stay§ (days) 1–79 3–13 7 9.79 (9.9) 1-257 11–31 19 23.8 (22.32) < 0.001 ( r: -0.39) ICC || 0–12 0-1.25 0 1.09 (1.69) 0–12 0–2 1 1.51 (2.03) < 0.001 ( r: -0.11) SAPS 3 ¶ 24–99 44–57 49 51.01 (10.57) 28–111 46–61 53 54.57 (11.31) < 0.001 ( r: -0.15) SMR** 0.73–90.81 9.89–29.52 15.91 21.7 (16.8) 1.35–95.21 12.05–37.68 22.15 27.32 (18.62) < 0.001 ( r: -0.15) SOFA Score †† 0–15 0–4 1 2.63 (2.9) 0–14 1–5 3 3.47 (2.95) < 0.001 ( r: -0.16) *Min–Max = minimum and maximum values †Q1–Q3 = first and third quartiles ‡SD = standard deviation §ICU = Intensive Care Unit ||CCI = Charlson Comorbidity Index ¶SAPS 3 = Simplified Acute Physiology Score **SMR = Standardized Mortality Ratio ††SOFA = Sequential Organ Failure Assessment ‡‡Mann–Whitney U test Regarding the use of healthcare resources, a statistically significant association was observed between the occurrence of AE and the use of mechanical ventilation, tracheostomy, vasopressors, renal replacement therapy, central venous catheters, invasive blood pressure monitoring, and indwelling urinary catheters (Table 5 ). Table 5 Associations between resource use in the ICU and adverse events (n = 1226). Variable No AE (n, %) AE (n, %) OR* p-value † (V Cremer) Use of Mechanical Ventilation No 517 (91.18%) 50 (8.82%) 6.71 < 0.001 ( v = 0.35) Yes 399 (60.64%) 259 (39.36%) Use of Tracheostomy No 858 (77.93%) 243 (22.07%) 4.02 < 0.001 ( v = 0.22) Yes 58 (46.77%) 66 (53.23%) Use of High-Flow Catheter No 753 (74.26%) 261 (25.74%) 0.411 ( v = 0.03) Yes 163 (77.25%) 48 (22.75%) Use of Vasopressors No 589 (83.19%) 119 (16.81%) 2.88 < 0.001 ( v = 0.23) Yes 327 (63.25%) 190 (36.75%) Use of Renal Replacement Therapy No 825 (77.83%) 235 (22.17%) 2.85 < 0.001 ( v = 0.18) Yes 91 (55.15%) 74 (44.85%) Use of Central Venous Catheter No 532 (87.5%) 76 (12.5%) 4.25 < 0.001 ( v = 0.29) Yes 384 (62.24%) 233 (37.76%) Use of Indwelling Urinary Catheter No 482 (89.93%) 54 (10.07%) 5.24 < 0.001 ( v = 0.31) Yes 434 (62.99%) 255 (37.01%) Use of Invasive Blood Pressure Monitoring No 588 (85.34%) 101 (14.66%) 3.69 < 0.001 ( v = 0.28) Yes 328 (61.19%) 208 (38.81%) * OR = Odds ratio. †= Chi-squared test. Discussion This study revealed that 25.2% of patients admitted to the ICU experienced at least one AE during their stay, with individual patients presenting between one and six events. A systematic review and meta-analysis of 24 studies published up to June 2020 that examined AEs during the transport of critically ill patients reported a 26.2% incidence of harmful events. This figure is consistent with the findings of the present study. However, the review also emphasized the heterogeneity across studies on AEs, which reflects variability in their occurrence and was also observed in this research [ 6 ]. Studies focusing specifically on AEs during the COVID-19 pandemic remain limited and continue to emerge. A study conducted in Ecuador from March 2020 to June 2021 reported a 13.3% incidence of AEs during hospitalization, with healthcare-associated infections being the most frequent, followed by phlebitis and pressure injuries [ 7 ]. These differences further underscore the variability in AE occurrence, which is influenced by contextual factors and reporting systems. The wide range in AE incidence reported in ICUs can be attributed to several factors, including the type of notification system adopted by healthcare institutions, the maturity of the local safety culture, the existence of nonpunitive reporting environments, and institutional and patient demographic profiles. External factors such as the COVID-19 pandemic have also played a significant role. Demographically, the study sample consisted predominantly of older male patients. In a large international cohort study conducted across 52 countries involving over 600,000 COVID-19 hospitalizations, the median patient age was 58 years, and 49.3% were male [ 8 ]. Similarly, a United States-based study examining the clinical outcomes of hospitalized COVID-19 patients reported a median age of 62 years, and 56.1% of the patients were male. In comparison, the present study revealed a mean age of 64 years, and 68.7% of the patients were male. These findings align with early pandemic observations that age and comorbidities are significant risk factors for hospitalization [ 9 ]. In terms of patient outcomes, 19.1% of ICU admissions in this study resulted in death. A study conducted in the interior of São Paulo, Brazil, investigating the epidemiological and clinical characteristics of hospitalized COVID-19 patients with AEs reported a mortality rate of 21.4% [ 10 ]. Although multicenter studies have suggested a mortality rate of approximately 21.5% among COVID-19 ICU patients, these rates may vary depending on the institutional case mix and population risk profile [ 8 ]. A critical challenge during the COVID-19 pandemic was hospital and ICU overcrowding, which emerged as a critical issue during the pandemic and was driven by prolonged hospital stays and limited bed turnover. In the present study, the average ICU length of stay was 13 days. A study from southern Brazil reported a median ICU stay of nine days among COVID-19 patients, corroborating our findings. The increased demand for ventilatory support during the pandemic, particularly invasive mechanical ventilation, necessitated the rapid expansion of respiratory care resources. In this study, the majority of ICU patients required invasive mechanical ventilation. A systematic review and meta-analysis revealed a 55.2% prevalence of invasive ventilation among COVID-19 ICU patients across the United States, United Kingdom, China, Mexico, France, and Italy [ 11 ]. The need for mechanical ventilation was significantly associated with AE occurrence, with patients requiring ventilation within the first 24 hours of ICU admission having a 2.16-fold greater risk of experiencing an AE. A systematic review and meta-analysis of COVID-19-related publications reported that one in three patients who underwent intubation experienced an AE [ 12 ]. Furthermore, a cohort study of 12,723 COVID-19 ICU patients in 78 Dutch hospitals reported invasive ventilation rates of 58.1% during the first wave and 58.2% during the second wave of the pandemic, supporting the findings of the present study [ 13 ]. Among all reported safety incidents in this study, 60.96% resulted in patient harm. This rate is lower than that reported in a bulletin from the Health Surveillance Center of São Paulo, which analyzed 35,751 incident reports during the pandemic and reported that 77.49% involved patient harm [ 14 ]. Despite their similar magnitude, few studies have evaluated AEs in terms of severity (e.g., no harm, harm, or near misses) and their relationship with patient outcomes during the pandemic. The institution where this study was conducted is characterized by a strong safety culture, which promotes learning not only from harmful events but also from near misses and no-harm incidents. Quality improvement is broadly integrated into the organization, involving all professionals in process optimization, reactive and proactive risk management, clinical protocols, and accreditation activities. Among the reported AEs, 4.49% were classified as severe. This figure is slightly higher than the 3.09% rate of severe harm incidents reported in the São Paulo State bulletin, which analyzes pandemic-related safety incidents [ 14 ]. A study conducted in a Rio de Janeiro ICU prior to the pandemic reported that 59.3% of AEs were related to clinical procedures, followed by 24.4% involving medications or IV fluids [ 15 ]. Similar findings were reported in two hospitals in Rio Grande do Sul, Brazil, during the COVID-19 pandemic, with 41.6% of moderate or severe AEs involving clinical procedures and 33.6% involving medications or fluids [ 16 ]. In terms of the AE categories, pressure injuries and device-related incidents were the most common. The frequent use of prone positioning to improve oxygenation in patients with respiratory failure, often for extended periods, may have contributed to pressure injuries. A Spanish study investigating AEs in mechanically ventilated patients in the prone position reported that 60.6% developed pressure injuries, particularly on the forehead, chin, nose, and cheekbones [ 17 ]. Similarly, a study from Tunisia reported that 18.5% of AEs in 10 ICUs were related to skin injuries [ 18 ]. National data from the Brazilian Health Regulatory Agency indicated that pressure injuries accounted for 27% of all reported incidents in São Paulo during the pandemic [ 14 ]. Patients who experienced AEs had greater mortality and longer ICU stays than did those who did not. A United States cohort study across 29 hospitals revealed that patients with diagnostic errors had a 6.6% probability of death [ 19 ]. Another Canadian study of more than 17,000 ICU admissions revealed that patients who experienced AEs had higher mortality, more invasive interventions, longer hospital stays, and greater costs [ 20 ]. A Brazilian cohort study with a similar methodology conducted before the pandemic revealed that patients who experienced AEs had an average ICU stay of 19 days and were twice as likely to die as those who did not experience AEs [ 15 ]. It is important to recognize the complex relationships among AE occurrence, patient severity, length of stay, and mortality. It remains unclear whether AEs are a consequence of greater severity or a contributing factor to it. This reflects the dynamic nature of healthcare as a complex adaptive system influenced by human factors and systemic interactions. This study also revealed a significant association between AE occurrence and the use of specific ICU resources, including mechanical ventilation, tracheostomy, vasopressors, renal replacement therapy, central venous catheters, indwelling urinary catheters, and invasive arterial pressure monitoring. A study conducted at a university hospital in São Paulo reported a similar association between the use of vasoactive drugs, ventilator-associated pneumonia, and mortality in patients with AEs [ 10 ]. Another study in Quito, Ecuador, reported greater use of central catheters, arterial lines, endotracheal tubes, tracheostomies, and gastric tubes among COVID-19 patients who experienced AEs than among those who did not [ 7 ]. In addition to incidence rates, the findings of this study offer critical insight into the experience of intensive care unit (ICU) care during a global health crisis. This study has several limitations. It did not compare AEs across different pandemic phases (e.g., first vs. second wave, pre- vs. postvaccination), which may have revealed organizational learning over time. Additionally, while the results are contextualized with data from other institutions, variations in safety culture and quality maturity may limit the generalizability of the findings. Conclusions This study enabled the characterization of incident reports, which were predominantly related to harmful events, with a smaller proportion of no-harm incidents. The main types of incidents were classified as being associated with patient-related accidents, clinical procedures, and medical equipment. The most frequently reported categories were skin and soft tissue injuries, and events related to invasive and non-invasive devices. The associations observed between adverse events, length of ICU stay, mortality, and the use of intensive care resources suggest that such events have a significant effect on the outcomes of critically ill patients. Abbreviations AE Adverse Events SAPS 3 Simplified Acute Physiology Score 3 SOFA Sequential Organ Failure Assessment ICU Intensive Care Unit Declarations Ethics approval and consent to participate Exemption from the informed consent form was granted owing to the observational and epidemiological nature of the study. The researcher signed a data confidentiality agreement. The research was conducted in accordance with relevant regulations and guidelines, including the Declaration of Helsinki. Ethical permission was obtained from Research Ethics Committee of the Hospital Alemão Oswaldo Cruz, São Paulo, SP, Brazil. Consent for publication Not applicable . Availability of data and materials The data that support the findings of this study are available from Hospital Alemão Oswaldo Cruz, but restrictions apply to the availability of these data, which were used under license for the current study and are not publicly available. However, data may be made available from the authors upon reasonable request and with permission from Hospital Alemão Oswaldo Cruz. Competing interests The authors declare that they have no competing interests. Funding This research received no specific grant from any funding agency in the public, commercial, or not-for-profit sectors. Authors’ contributions GSZ and EB contributed to the conception of the study, data analysis and interpretation, manuscript drafting, and critical revision of its intellectual content. GCSG contributed to manuscript drafting and critical revision of its intellectual content. All authors read and approved the final manuscript . Acknowledgement We would like to thank Hospital Alemão Oswaldo Cruz for the technological and epidemiological support provided during the data collection process . References Bates DW, Singh H. Two Decades Since To Err Is Human: an Assessment of Progress and Emerging Priorities in Patient Safety. Health Aff (Millwood). 2018; 37(11): 1736-43. doi: 10.1377/hlthaff.2018.0738. Monti M, Coppolaro A, Guarnieri S. Mapping strategies for strengthening safety culture: a scoping review. Healthcare (Basel). 2024;12(12):1194. doi:10.3390/healthcare12121194 Martins C, Costa JA, Oliveira IBA, Lenhardt MM, Silva MS, Borges CD et al. Difficulties and challenges faced by the nursing team in the scenario of the COVID-19 pandemic. Research, Society and Development, 2022; 11(6): e4311627150. doi: 10.33448/rsd-v11i6.27150. Yesudhas D, Srivastava A, Gromiha MM. COVID-19 outbreak: history, mechanism, transmission, structural studies and therapeutics. 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Zimmermann","email":"data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAZAAAAAyAQMAAABI0h/eAAAABlBMVEX///8AAABVwtN+AAAACXBIWXMAAA7EAAAOxAGVKw4bAAAA1ElEQVRIiWNgGAWjYFACxgaGBBDN3gAkDCxI0cJzAKRFghTbJMAaidAiH5Hc/OFhzjY585nPr274USDBwN/enYBXi+GNxAaDxG23jWVu55Td7AE6TOLM2Q34tcxIbEgAakmcIZ2TdoMHqMVAIpewlgNALfUzJM+k3fxDjBZ5icTGBqCWBAkJ9mO3ibLFgOdhMwNQi+EMnhy22zIGEjwE/SLfnv74489tt+Ul2I8/u/nmj40cf3svAVsOwJk8BmASr3KwLQ1wJvsDgqpHwSgYBaNgZAIA8XNK3Qcd7ZsAAAAASUVORK5CYII=","orcid":"","institution":"Federal University of São Paulo","correspondingAuthor":true,"prefix":"","firstName":"Guilherme","middleName":"dos Santos","lastName":"Zimmermann","suffix":""},{"id":530858278,"identity":"4b782cc0-3fd1-40ff-a54f-c89dfbf6d013","order_by":1,"name":"Geisa Colebrusco de Souza Gonçalves","email":"","orcid":"","institution":"Federal University of São Paulo","correspondingAuthor":false,"prefix":"","firstName":"Geisa","middleName":"Colebrusco de Souza","lastName":"Gonçalves","suffix":""},{"id":530858279,"identity":"760b134d-57ea-4af4-b02a-861a848b460c","order_by":2,"name":"Elena Bohomol","email":"","orcid":"","institution":"Federal University of São Paulo","correspondingAuthor":false,"prefix":"","firstName":"Elena","middleName":"","lastName":"Bohomol","suffix":""}],"badges":[],"createdAt":"2025-09-04 13:23:19","currentVersionCode":1,"declarations":"","doi":"10.21203/rs.3.rs-7536535/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-7536535/v1","draftVersion":[],"editorialEvents":[],"editorialNote":"","failedWorkflow":false,"files":[{"id":93759703,"identity":"662e8e79-2964-4b10-8517-107def4775f6","added_by":"auto","created_at":"2025-10-17 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09:24:04","extension":"xml","order_by":2,"title":"","display":"","copyAsset":false,"role":"acdc-reference","size":93863,"visible":true,"origin":"","legend":"","description":"","filename":"638d76ff45d74a4d85837cb248a51b031enriched.xml","url":"https://assets-eu.researchsquare.com/files/rs-7536535/v1/dc8d07ac05142b3ef28afe83.xml"},{"id":93759702,"identity":"b41eae2c-f189-4aa3-a0e3-21fea4ef3ee5","added_by":"auto","created_at":"2025-10-17 09:24:01","extension":"xml","order_by":3,"title":"","display":"","copyAsset":false,"role":"acdc-reference","size":91539,"visible":true,"origin":"","legend":"","description":"","filename":"638d76ff45d74a4d85837cb248a51b031structuring.xml","url":"https://assets-eu.researchsquare.com/files/rs-7536535/v1/079d770e50264b73ebcfe9ba.xml"},{"id":93759719,"identity":"23c72ec2-4af4-47a0-8430-173a700e19e8","added_by":"auto","created_at":"2025-10-17 09:24:04","extension":"html","order_by":4,"title":"","display":"","copyAsset":false,"role":"acdc-reference","size":99100,"visible":true,"origin":"","legend":"","description":"","filename":"earlyproof.html","url":"https://assets-eu.researchsquare.com/files/rs-7536535/v1/a5b54bbe23abccdcf17b2531.html"},{"id":93759977,"identity":"2fba158d-c9e2-4a36-aba7-0cae34dfdf6b","added_by":"auto","created_at":"2025-10-17 09:32:04","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":754947,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-7536535/v1/cc37bda8-7615-4fe9-8d54-0100c8fce432.pdf"}],"financialInterests":"No competing interests reported.","formattedTitle":"Patient Safety Incidents in an Intensive Care Unit during the COVID‑19 Pandemic: A Retrospective Cohort Study","fulltext":[{"header":"Background","content":"\u003cp\u003eSince the publication of To Err is Human: Building a Safer Health System by the Institute of Medicine in the early 2000s, a landmark in the global patient safety movement, there has been increasing attention to research and initiatives aimed at improving safety in healthcare settings. More than two decades later, preventable patient harm remains a critical concern, underscoring the persistent need to better understand the complexity of healthcare errors and to ensure the reliable and continuous monitoring of adverse events (AE) [\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e].\u003c/p\u003e\u003cp\u003eAE in healthcare often result from multifactorial causes, including the high volume of information flow, interdisciplinary team dynamics, the integration of new technologies, and the challenges of operating in complex and highly stimulating environments. While learning from errors and understanding their root causes are essential, implementing proactive safety barriers and preventive strategies to reduce the occurrence of AEs is equally important [\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e].\u003c/p\u003e\u003cp\u003eThe development of such safety systems requires a high degree of organizational maturity. In Brazil, structural limitations such as shortages of trained professionals, prolonged wait times, resource constraints, and gaps in public health policy continue to pose significant challenges to the implementation of safe care practices [\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e]. These barriers were further intensified during the COVID-19 pandemic.\u003c/p\u003e\u003cp\u003eOwing to its high transmission rate and initially undefined clinical protocols, COVID-19 has rapidly escalated into a global public health emergency. In response, hospitals are required to rapidly reorganize their operations, which include emergency staffing, expansion of intensive care unit (ICU) capacity, and procurement of essential resources such as personal protective equipment, disinfectants, critical medications, mechanical ventilators, and infusion pumps [\u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e].\u003c/p\u003e\u003cp\u003eThese demands exposed systemic vulnerabilities across healthcare services, particularly the absence of contingency planning, high costs of medical supplies, ICU overcrowding, and inefficiencies in operational workflows. Consequently, patient safety may have been compromised, contributing to an increased incidence of AE [\u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e]. Given this context, the present study aimed to analyze patient safety incidents in an ICU during the COVID-19 pandemic and to evaluate their associations with patient outcomes.\u003c/p\u003e"},{"header":"Methods","content":"\u003cdiv id=\"Sec3\" class=\"Section2\"\u003e\u003ch2\u003eStudy Design and Setting\u003c/h2\u003e\u003cp\u003eThis was a retrospective cohort study conducted in a private tertiary hospital in S\u0026atilde;o Paulo, Brazil. The hospital has 350 beds and expanded its ICU capacity from 44 to 89 beds during the pandemic. The ICU was divided into seven COVID-19 units and four non-COVID-19 units. The design and reporting of the studies were guided by the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) guidelines.\u003c/p\u003e\u003c/div\u003e\n\u003ch3\u003ePopulation and Data Collection\u003c/h3\u003e\n\u003cp\u003eData were collected from March 2020 to July 2021. The cohort included patients aged\u0026thinsp;\u0026ge;\u0026thinsp;17 years with a confirmed diagnosis of COVID-19 (positive RT-PCR). Patients were included in the AE group if they had at least one AE reported during their ICU stay. Data were extracted from clinical and epidemiological information systems and the hospital's safety incident reporting database. The variables included: date of the AE, number of AEs, type and severity of AE, patient age and sex, reason for hospital discharge, readmission within 30 days, ICU readmission, ICU outcome, ICU length of stay, Charlson Comorbidity Index, Simplified Acute Physiology Score 3 (SAPS 3), standardized mortality ratio, and Sequential Organ Failure Assessment (SOFA) score.\u003c/p\u003e\u003cdiv id=\"Sec5\" class=\"Section2\"\u003e\u003ch2\u003eData analysis\u003c/h2\u003e\u003cp\u003eDescriptive statistics were used for categorical and numerical variables. Associations were analyzed via the chi-square test or Fisher's exact test for categorical variables and the t test, Mann‒Whitney test, or Shapiro‒Wilk test for continuous variables. Significance was set at p\u0026thinsp;\u0026lt;\u0026thinsp;0.05.\u003c/p\u003e\u003c/div\u003e\n\u003ch3\u003eEthical considerations\u003c/h3\u003e\n\u003cp\u003e The study was approved by the Institutional Research Ethics Committee (CAAE 51449121.8.0000.0070). Given the observational design, informed consent was waived. Data confidentiality was ensured.\u003c/p\u003e"},{"header":"Results","content":"\u003cp\u003eDuring the data collection period, a total of 1,226 ICU admissions were recorded, of which 68.76% were male. Among these admissions, 25.2% involved at least one AE during the ICU stay. In terms of hospital outcomes, 73.46% of patients were discharged in improved condition, whereas 24.16% died. With respect to ICU discharge status, 79.18% were transferred to a hospital ward, and 19.1% died during their ICU stay (Table\u0026nbsp;\u003cspan refid=\"Tab1\" class=\"InternalRef\"\u003e1\u003c/span\u003e).\u003c/p\u003e\u003cp\u003e\u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab1\" border=\"1\"\u003e\u003ccaption language=\"En\"\u003e\u003cdiv class=\"CaptionNumber\"\u003eTable 1\u003c/div\u003e\u003cdiv class=\"CaptionContent\"\u003e\u003cp\u003eCategorical variables describing the demographic characteristics of ICU patients (n\u0026thinsp;=\u0026thinsp;1,226).\u003c/p\u003e\u003c/div\u003e\u003c/caption\u003e\u003ccolgroup cols=\"2\"\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e\u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e\u003cthead\u003e\u003ctr\u003e\u003cth align=\"left\" colname=\"c1\"\u003e\u003cp\u003eVariable\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c2\"\u003e\u003cp\u003en (%)\u003c/p\u003e\u003c/th\u003e\u003c/tr\u003e\u003c/thead\u003e\u003ctbody\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eAdverse events during ICU* stay\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eNo\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e\u003cp\u003e917 (74.8%)\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eYes\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e\u003cp\u003e309 (25.2%)\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eSex\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eMale\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e\u003cp\u003e843 (68.76%)\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eFemale\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e\u003cp\u003e383 (31.24%)\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eType of hospital admission\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eEmergency\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e\u003cp\u003e1,183 (96.49%)\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eElective\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e\u003cp\u003e42 (3.43%)\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eWorkplace accident\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e\u003cp\u003e1 (0.08%)\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eHospital discharge outcome\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eDischarged (improved)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e\u003cp\u003e897 (73.87%)\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eDeath\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e\u003cp\u003e295 (24.16%)\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eTransferred to another hospital\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e\u003cp\u003e24 (1.97%)\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eICU* outcome\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eDischarged to hospital ward\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e\u003cp\u003e970 (79.18%)\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eDeath\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e\u003cp\u003e234 (19.1%)\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eTransferred to another hospital\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e\u003cp\u003e21 (1.71%)\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eHospital readmission within 30 days\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eNo\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e\u003cp\u003e1,159 (94.54%)\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eYes\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e\u003cp\u003e67 (5.46%)\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eICU* readmission\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eNo\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e\u003cp\u003e1,136 (92.66%)\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eYes\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e\u003cp\u003e90 (7.34%)\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003c/tbody\u003e\u003c/colgroup\u003e\u003ctfoot\u003e\u003ctr\u003e\u003ctd colspan=\"2\"\u003e*ICU\u0026thinsp;=\u0026thinsp;Intensive Care Unit\u003c/td\u003e\u003c/tr\u003e\u003c/tfoot\u003e\u003c/table\u003e\u003c/div\u003e\u003c/p\u003e\u003cp\u003eAmong the selected samples, the number of AE per patient ranged from zero to six. The mean patient age was 65 years, and the average length of stay in the ICU was 13 days (Table\u0026nbsp;\u003cspan refid=\"Tab2\" class=\"InternalRef\"\u003e2\u003c/span\u003e).\u003c/p\u003e\u003cp\u003e\u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab2\" border=\"1\"\u003e\u003ccaption language=\"En\"\u003e\u003cdiv class=\"CaptionNumber\"\u003eTable 2\u003c/div\u003e\u003cdiv class=\"CaptionContent\"\u003e\u003cp\u003eNumerical variables describing the demographic and clinical characteristics of ICU patients (n\u0026thinsp;=\u0026thinsp;1,226)\u003c/p\u003e\u003c/div\u003e\u003c/caption\u003e\u003ccolgroup cols=\"5\"\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e\u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c5\" colnum=\"5\"\u003e\u003c/div\u003e\u003cthead\u003e\u003ctr\u003e\u003cth align=\"left\" colname=\"c1\"\u003e\u003cp\u003eVariable\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c2\"\u003e\u003cp\u003eMin\u0026ndash;Max*\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c3\"\u003e\u003cp\u003eQ1\u0026ndash;Q3\u0026dagger;\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c4\"\u003e\u003cp\u003eMedian\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c5\"\u003e\u003cp\u003eMean (SD\u0026Dagger;)\u003c/p\u003e\u003c/th\u003e\u003c/tr\u003e\u003c/thead\u003e\u003ctbody\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eNumber of adverse events\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e0\u0026ndash;6\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e0\u0026ndash;1\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e0\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e\u003cp\u003e0.36 (0.73)\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eAge (years)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e17\u0026ndash;100\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e53\u0026ndash;76\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e65\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e\u003cp\u003e64.06 (15.88)\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eICU length of stay (days)\u0026sect;\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e1\u0026ndash;257\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e4\u0026ndash;17\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e9\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e\u003cp\u003e13.32 (15.35)\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eCharlson Comorbidity Index\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e0\u0026ndash;12\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e0\u0026ndash;2\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e1\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e\u003cp\u003e1.20 (1.79)\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eSAPS 3 score\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e24\u0026ndash;111\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e45\u0026ndash;58\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e50\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e\u003cp\u003e51.91 (10.87)\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eStandardized Mortality Ratio\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e0.73\u0026ndash;95.21\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e10.93\u0026ndash;31.50\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e17.35\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e\u003cp\u003e23.12 (17.44)\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eSOFA score\u0026para;\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e0\u0026ndash;15\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e1\u0026ndash;4\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e2\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e\u003cp\u003e2.84 (2.93)\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003c/tbody\u003e\u003c/colgroup\u003e\u003ctfoot\u003e\u003ctr\u003e\u003ctd colspan=\"5\"\u003e*Min\u0026ndash;Max\u0026thinsp;=\u0026thinsp;Minimum and maximum values\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd colspan=\"5\"\u003e\u0026dagger;Q1\u0026ndash;Q3\u0026thinsp;=\u0026thinsp;First and third quartiles\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd colspan=\"5\"\u003e\u0026Dagger;SD\u0026thinsp;=\u0026thinsp;Standard deviation\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd colspan=\"5\"\u003e\u0026sect;ICU\u0026thinsp;=\u0026thinsp;Intensive Care Unit\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd colspan=\"5\"\u003e||SAPS\u0026thinsp;=\u0026thinsp;Simplified Acute Physiology Score\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd colspan=\"5\"\u003e\u0026para;SOFA\u0026thinsp;=\u0026thinsp;Sequential Organ Failure Assessment\u003c/td\u003e\u003c/tr\u003e\u003c/tfoot\u003e\u003c/table\u003e\u003c/div\u003e\u003c/p\u003e\u003cp\u003eThe analysis of safety incidents was based on the hospital's internal incident reporting system. In total, during the study period, 438 safety incidents were reported, with the majority occurring during the night shift (47.03%), followed by 27.85% in the morning and 25.11% in the afternoon. Nurses were the professionals who reported the most incidents (73.52%).\u003c/p\u003e\u003cp\u003eRegarding the type of incident, 60.96% were classified as incidents with harm. Among these, 86.52% were mild, 7.87% were moderate, 4.49% were severe, and 1.12% were sentinel events. Among all reported incidents, 27.75% were related to patient accidents, 27.29% to clinical procedures and processes, and 23.62% to medical devices. The most frequently reported incident categories were skin and soft tissue injuries (24.89%) and issues related to invasive and noninvasive devices (16.67%).\u003c/p\u003e\u003cp\u003eTo assess the impact of AE on ICU patients during hospitalization, we analyzed the associations between the study variables and the presence or absence of AEs in the ICU. Table\u0026nbsp;\u003cspan refid=\"Tab3\" class=\"InternalRef\"\u003e3\u003c/span\u003e highlights the associations between ICU readmission and the occurrence of AEs, as well as a higher rate of events among patients whose outcome was death.\u003c/p\u003e\u003cp\u003e\u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab3\" border=\"1\"\u003e\u003ccaption language=\"En\"\u003e\u003cdiv class=\"CaptionNumber\"\u003eTable 3\u003c/div\u003e\u003cdiv class=\"CaptionContent\"\u003e\u003cp\u003eAssociation between categorical variables of hospitalized patients and adverse events (n\u0026thinsp;=\u0026thinsp;1226).\u003c/p\u003e\u003c/div\u003e\u003c/caption\u003e\u003ccolgroup cols=\"4\"\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e\u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e\u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e\u003cthead\u003e\u003ctr\u003e\u003cth align=\"left\" colname=\"c1\"\u003e\u003cp\u003eVariables\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c2\"\u003e\u003cp\u003eAE \u0026ndash; No\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c3\"\u003e\u003cp\u003eAE \u0026ndash; Yes\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c4\"\u003e\u003cp\u003ep-value\u003c/p\u003e\u003c/th\u003e\u003c/tr\u003e\u003c/thead\u003e\u003ctbody\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eSex\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\" morerows=\"2\" rowspan=\"3\"\u003e\u003cp\u003e0.155 \u0026dagger; (Cram\u0026eacute;r's V\u0026thinsp;=\u0026thinsp;0.04)\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eFemale\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e\u003cp\u003e297 (77.55%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e\u003cp\u003e86 (22.45%)\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eMale\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e\u003cp\u003e620 (73.55%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e\u003cp\u003e223 (26.45%)\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eHospital Discharge Outcome\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\" morerows=\"3\" rowspan=\"4\"\u003e\u003cp\u003e\u0026lt;\u0026thinsp;0.001 \u0026Dagger;\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eDischarged improved\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e\u003cp\u003e726 (80.48%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e\u003cp\u003e176 (19.51%)\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eDeath\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e\u003cp\u003e172 (58.31%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e\u003cp\u003e123 (41.69%)\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eHospital transfer\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e\u003cp\u003e19 (79.17%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e\u003cp\u003e5 (20.83%)\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eICU* Readmission\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\" morerows=\"2\" rowspan=\"3\"\u003e\u003cp\u003e\u0026lt;\u0026thinsp;0.001 \u0026dagger; (Cram\u0026eacute;r's V\u0026thinsp;=\u0026thinsp;0.12)\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eNo\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e\u003cp\u003e866 (76.23%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e\u003cp\u003e270 (23.77%)\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eYes\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e\u003cp\u003e51 (56.67%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e\u003cp\u003e39 (43.33%)\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eICU* Outcome\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\" morerows=\"3\" rowspan=\"4\"\u003e\u003cp\u003e\u0026lt;\u0026thinsp;0.001 \u0026dagger; (Cram\u0026eacute;r's V\u0026thinsp;=\u0026thinsp;0.18)\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eTransfer to ward\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e\u003cp\u003e763 (78.66%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e\u003cp\u003e207 (21.34%)\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eDeath\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e\u003cp\u003e138 (58.97%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e\u003cp\u003e96 (41.03%)\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eHospital transfer\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e\u003cp\u003e16 (76.19%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e\u003cp\u003e5 (23.81%)\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003c/tbody\u003e\u003c/colgroup\u003e\u003ctfoot\u003e\u003ctr\u003e\u003ctd colspan=\"4\"\u003e*ICU\u0026thinsp;=\u0026thinsp;Intensive Care Unit\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd colspan=\"4\"\u003e\u0026dagger; Chi-square test;\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd colspan=\"4\"\u003e\u0026Dagger; Fisher's exact test\u003c/td\u003e\u003c/tr\u003e\u003c/tfoot\u003e\u003c/table\u003e\u003c/div\u003e\u003c/p\u003e\u003cp\u003eAn association was also observed between the clinical data collected at the time of ICU admission and the occurrence of AE. Table\u0026nbsp;\u003cspan refid=\"Tab4\" class=\"InternalRef\"\u003e4\u003c/span\u003e presents the associations between AEs and length of stay in the ICU, the Charlson Comorbidity Index, the SAPS 3 score, the standardized mortality ratio based on the SAPS 3 score, and the SOFA score.\u003c/p\u003e\u003cp\u003e\u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab4\" border=\"1\"\u003e\u003ccaption language=\"En\"\u003e\u003cdiv class=\"CaptionNumber\"\u003eTable 4\u003c/div\u003e\u003cdiv class=\"CaptionContent\"\u003e\u003cp\u003eAssociation between numerical variables of hospitalized patients and adverse events (n\u0026thinsp;=\u0026thinsp;1226).\u003c/p\u003e\u003c/div\u003e\u003c/caption\u003e\u003ccolgroup cols=\"10\"\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e\u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c5\" colnum=\"5\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c6\" colnum=\"6\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c7\" colnum=\"7\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c8\" colnum=\"8\"\u003e\u003c/div\u003e\u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c9\" colnum=\"9\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c10\" colnum=\"10\"\u003e\u003c/div\u003e\u003cthead\u003e\u003ctr\u003e\u003cth align=\"left\" colname=\"c1\" morerows=\"1\" rowspan=\"2\"\u003e\u003cp\u003eVariable\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colspan=\"4\" nameend=\"c5\" namest=\"c2\"\u003e\u003cp\u003eAE No\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colspan=\"4\" nameend=\"c9\" namest=\"c6\"\u003e\u003cp\u003eAE Yes\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c10\" morerows=\"1\" rowspan=\"2\"\u003e\u003cp\u003eP valor \u0026Dagger;\u0026Dagger;\u003c/p\u003e\u003c/th\u003e\u003c/tr\u003e\u003ctr\u003e\u003cth align=\"left\" colname=\"c2\"\u003e\u003cp\u003eMin\u0026ndash;Max*\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c3\"\u003e\u003cp\u003eQ1\u0026ndash;Q3\u0026dagger;\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c4\"\u003e\u003cp\u003eMedian\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c5\"\u003e\u003cp\u003eMean (SD\u0026Dagger;)\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c6\"\u003e\u003cp\u003eMin\u0026ndash;Max*\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c7\"\u003e\u003cp\u003eQ1\u0026ndash;Q3\u0026dagger;\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c8\"\u003e\u003cp\u003eMedian\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c9\"\u003e\u003cp\u003eMean (SD\u0026Dagger;)\u003c/p\u003e\u003c/th\u003e\u003c/tr\u003e\u003c/thead\u003e\u003ctbody\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eAge (years)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e17\u0026ndash;100\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e52\u0026ndash;75\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e63\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e\u003cp\u003e63.35 (16.09)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u003cp\u003e23\u0026ndash;96\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c7\"\u003e\u003cp\u003e57\u0026ndash;77\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c8\"\u003e\u003cp\u003e67\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c9\"\u003e\u003cp\u003e66.14 (15.09)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c10\"\u003e\u003cp\u003e0.003\u003c/p\u003e\u003cp\u003e\u003csup\u003e(\u003c/sup\u003er: -0.09)\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eICU Length of Stay\u0026sect; (days)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e1\u0026ndash;79\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e3\u0026ndash;13\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e7\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e\u003cp\u003e9.79 (9.9)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u003cp\u003e1-257\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c7\"\u003e\u003cp\u003e11\u0026ndash;31\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c8\"\u003e\u003cp\u003e19\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c9\"\u003e\u003cp\u003e23.8 (22.32)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c10\"\u003e\u003cp\u003e\u0026lt;\u0026thinsp;0.001 \u003csup\u003e(\u003c/sup\u003er: -0.39)\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eICC\u003csup\u003e||\u003c/sup\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e0\u0026ndash;12\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e0-1.25\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e0\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e\u003cp\u003e1.09 (1.69)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u003cp\u003e0\u0026ndash;12\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c7\"\u003e\u003cp\u003e0\u0026ndash;2\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c8\"\u003e\u003cp\u003e1\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c9\"\u003e\u003cp\u003e1.51 (2.03)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c10\"\u003e\u003cp\u003e\u0026lt;\u0026thinsp;0.001 \u003csup\u003e(\u003c/sup\u003er: -0.11)\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eSAPS 3\u003csup\u003e\u0026para;\u003c/sup\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e24\u0026ndash;99\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e44\u0026ndash;57\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e49\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e\u003cp\u003e51.01 (10.57)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u003cp\u003e28\u0026ndash;111\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c7\"\u003e\u003cp\u003e46\u0026ndash;61\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c8\"\u003e\u003cp\u003e53\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c9\"\u003e\u003cp\u003e54.57 (11.31)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c10\"\u003e\u003cp\u003e\u0026lt;\u0026thinsp;0.001 \u003csup\u003e(\u003c/sup\u003er: -0.15)\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eSMR**\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e0.73\u0026ndash;90.81\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e9.89\u0026ndash;29.52\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e15.91\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e\u003cp\u003e21.7 (16.8)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u003cp\u003e1.35\u0026ndash;95.21\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c7\"\u003e\u003cp\u003e12.05\u0026ndash;37.68\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c8\"\u003e\u003cp\u003e22.15\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c9\"\u003e\u003cp\u003e27.32 (18.62)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c10\"\u003e\u003cp\u003e\u0026lt;\u0026thinsp;0.001 \u003csup\u003e(\u003c/sup\u003er: -0.15)\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eSOFA Score\u003csup\u003e\u0026dagger;\u0026dagger;\u003c/sup\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e0\u0026ndash;15\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e0\u0026ndash;4\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e1\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e\u003cp\u003e2.63 (2.9)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u003cp\u003e0\u0026ndash;14\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c7\"\u003e\u003cp\u003e1\u0026ndash;5\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c8\"\u003e\u003cp\u003e3\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c9\"\u003e\u003cp\u003e3.47 (2.95)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c10\"\u003e\u003cp\u003e\u0026lt;\u0026thinsp;0.001 \u003csup\u003e(\u003c/sup\u003er: -0.16)\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003c/tbody\u003e\u003c/colgroup\u003e\u003ctfoot\u003e\u003ctr\u003e\u003ctd colspan=\"10\"\u003e*Min\u0026ndash;Max\u0026thinsp;=\u0026thinsp;minimum and maximum values\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd colspan=\"10\"\u003e\u0026dagger;Q1\u0026ndash;Q3\u0026thinsp;=\u0026thinsp;first and third quartiles\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd colspan=\"10\"\u003e\u0026Dagger;SD\u0026thinsp;=\u0026thinsp;standard deviation\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd colspan=\"10\"\u003e\u0026sect;ICU\u0026thinsp;=\u0026thinsp;Intensive Care Unit\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd colspan=\"10\"\u003e||CCI\u0026thinsp;=\u0026thinsp;Charlson Comorbidity Index\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd colspan=\"10\"\u003e\u0026para;SAPS 3\u0026thinsp;=\u0026thinsp;Simplified Acute Physiology Score\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd colspan=\"10\"\u003e**SMR\u0026thinsp;=\u0026thinsp;Standardized Mortality Ratio\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd colspan=\"10\"\u003e\u0026dagger;\u0026dagger;SOFA\u0026thinsp;=\u0026thinsp;Sequential Organ Failure Assessment\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd colspan=\"10\"\u003e\u0026Dagger;\u0026Dagger;Mann\u0026ndash;Whitney U test\u003c/td\u003e\u003c/tr\u003e\u003c/tfoot\u003e\u003c/table\u003e\u003c/div\u003e\u003c/p\u003e\u003cp\u003eRegarding the use of healthcare resources, a statistically significant association was observed between the occurrence of AE and the use of mechanical ventilation, tracheostomy, vasopressors, renal replacement therapy, central venous catheters, invasive blood pressure monitoring, and indwelling urinary catheters (Table\u0026nbsp;\u003cspan refid=\"Tab5\" class=\"InternalRef\"\u003e5\u003c/span\u003e).\u003c/p\u003e\u003cp\u003e\u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab5\" border=\"1\"\u003e\u003ccaption language=\"En\"\u003e\u003cdiv class=\"CaptionNumber\"\u003eTable 5\u003c/div\u003e\u003cdiv class=\"CaptionContent\"\u003e\u003cp\u003eAssociations between resource use in the ICU and adverse events (n\u0026thinsp;=\u0026thinsp;1226).\u003c/p\u003e\u003c/div\u003e\u003c/caption\u003e\u003ccolgroup cols=\"5\"\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e\u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e\u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e\u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c5\" colnum=\"5\"\u003e\u003c/div\u003e\u003cthead\u003e\u003ctr\u003e\u003cth align=\"left\" colname=\"c1\"\u003e\u003cp\u003eVariable\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c2\"\u003e\u003cp\u003eNo AE (n, %)\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c3\"\u003e\u003cp\u003eAE (n, %)\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c4\"\u003e\u003cp\u003eOR*\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c5\"\u003e\u003cp\u003ep-value\u003csup\u003e\u0026dagger;\u003c/sup\u003e\u003c/p\u003e\u003cp\u003e(V Cremer)\u003c/p\u003e\u003c/th\u003e\u003c/tr\u003e\u003c/thead\u003e\u003ctbody\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eUse of Mechanical Ventilation\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eNo\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e\u003cp\u003e517 (91.18%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e\u003cp\u003e50 (8.82%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c4\" morerows=\"1\" rowspan=\"2\"\u003e\u003cp\u003e6.71\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e\u0026lt;\u0026thinsp;0.001 \u003csup\u003e(\u003c/sup\u003ev\u0026thinsp;=\u0026thinsp;0.35)\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eYes\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e\u003cp\u003e399 (60.64%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e\u003cp\u003e259 (39.36%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eUse of Tracheostomy\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eNo\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e\u003cp\u003e858 (77.93%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e\u003cp\u003e243 (22.07%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c4\" morerows=\"1\" rowspan=\"2\"\u003e\u003cp\u003e4.02\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e\u0026lt;\u0026thinsp;0.001 \u003csup\u003e(\u003c/sup\u003ev\u0026thinsp;=\u0026thinsp;0.22)\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eYes\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e\u003cp\u003e58 (46.77%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e\u003cp\u003e66 (53.23%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eUse of High-Flow Catheter\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eNo\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e\u003cp\u003e753 (74.26%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e\u003cp\u003e261 (25.74%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\" morerows=\"1\" rowspan=\"2\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e0.411 \u003csup\u003e(\u003c/sup\u003ev\u0026thinsp;=\u0026thinsp;0.03)\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eYes\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e\u003cp\u003e163 (77.25%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e\u003cp\u003e48 (22.75%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eUse of Vasopressors\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eNo\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e\u003cp\u003e589 (83.19%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e\u003cp\u003e119 (16.81%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c4\" morerows=\"1\" rowspan=\"2\"\u003e\u003cp\u003e2.88\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e\u0026lt;\u0026thinsp;0.001 \u003csup\u003e(\u003c/sup\u003ev\u0026thinsp;=\u0026thinsp;0.23)\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eYes\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e\u003cp\u003e327 (63.25%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e\u003cp\u003e190 (36.75%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eUse of Renal Replacement Therapy\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eNo\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e\u003cp\u003e825 (77.83%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e\u003cp\u003e235 (22.17%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c4\" morerows=\"1\" rowspan=\"2\"\u003e\u003cp\u003e2.85\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e\u0026lt;\u0026thinsp;0.001 \u003csup\u003e(\u003c/sup\u003ev\u0026thinsp;=\u0026thinsp;0.18)\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eYes\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e\u003cp\u003e91 (55.15%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e\u003cp\u003e74 (44.85%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eUse of Central Venous Catheter\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eNo\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e\u003cp\u003e532 (87.5%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e\u003cp\u003e76 (12.5%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c4\" morerows=\"1\" rowspan=\"2\"\u003e\u003cp\u003e4.25\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e\u0026lt;\u0026thinsp;0.001 \u003csup\u003e(\u003c/sup\u003ev\u0026thinsp;=\u0026thinsp;0.29)\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eYes\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e\u003cp\u003e384 (62.24%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e\u003cp\u003e233 (37.76%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eUse of Indwelling Urinary Catheter\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eNo\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e\u003cp\u003e482 (89.93%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e\u003cp\u003e54 (10.07%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c4\" morerows=\"1\" rowspan=\"2\"\u003e\u003cp\u003e5.24\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e\u0026lt;\u0026thinsp;0.001 \u003csup\u003e(\u003c/sup\u003ev\u0026thinsp;=\u0026thinsp;0.31)\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eYes\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e\u003cp\u003e434 (62.99%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e\u003cp\u003e255 (37.01%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eUse of Invasive Blood Pressure Monitoring\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eNo\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e\u003cp\u003e588 (85.34%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e\u003cp\u003e101 (14.66%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c4\" morerows=\"1\" rowspan=\"2\"\u003e\u003cp\u003e3.69\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e\u0026lt;\u0026thinsp;0.001 \u003csup\u003e(\u003c/sup\u003ev\u0026thinsp;=\u0026thinsp;0.28)\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eYes\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e\u003cp\u003e328 (61.19%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e\u003cp\u003e208 (38.81%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e\u003c/tr\u003e\u003c/tbody\u003e\u003c/colgroup\u003e\u003c/table\u003e\u003c/div\u003e\u003c/p\u003e\u003cp\u003e* OR\u0026thinsp;=\u0026thinsp;Odds ratio.\u003c/p\u003e\u003cp\u003e\u0026dagger;= Chi-squared test.\u003c/p\u003e"},{"header":"Discussion","content":"\u003cp\u003eThis study revealed that 25.2% of patients admitted to the ICU experienced at least one AE during their stay, with individual patients presenting between one and six events. A systematic review and meta-analysis of 24 studies published up to June 2020 that examined AEs during the transport of critically ill patients reported a 26.2% incidence of harmful events. This figure is consistent with the findings of the present study. However, the review also emphasized the heterogeneity across studies on AEs, which reflects variability in their occurrence and was also observed in this research [\u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e].\u003c/p\u003e\u003cp\u003eStudies focusing specifically on AEs during the COVID-19 pandemic remain limited and continue to emerge. A study conducted in Ecuador from March 2020 to June 2021 reported a 13.3% incidence of AEs during hospitalization, with healthcare-associated infections being the most frequent, followed by phlebitis and pressure injuries [\u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e]. These differences further underscore the variability in AE occurrence, which is influenced by contextual factors and reporting systems.\u003c/p\u003e\u003cp\u003eThe wide range in AE incidence reported in ICUs can be attributed to several factors, including the type of notification system adopted by healthcare institutions, the maturity of the local safety culture, the existence of nonpunitive reporting environments, and institutional and patient demographic profiles. External factors such as the COVID-19 pandemic have also played a significant role.\u003c/p\u003e\u003cp\u003eDemographically, the study sample consisted predominantly of older male patients. In a large international cohort study conducted across 52 countries involving over 600,000 COVID-19 hospitalizations, the median patient age was 58 years, and 49.3% were male [\u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e]. Similarly, a United States-based study examining the clinical outcomes of hospitalized COVID-19 patients reported a median age of 62 years, and 56.1% of the patients were male. In comparison, the present study revealed a mean age of 64 years, and 68.7% of the patients were male. These findings align with early pandemic observations that age and comorbidities are significant risk factors for hospitalization [\u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e].\u003c/p\u003e\u003cp\u003eIn terms of patient outcomes, 19.1% of ICU admissions in this study resulted in death. A study conducted in the interior of S\u0026atilde;o Paulo, Brazil, investigating the epidemiological and clinical characteristics of hospitalized COVID-19 patients with AEs reported a mortality rate of 21.4% [\u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e]. Although multicenter studies have suggested a mortality rate of approximately 21.5% among COVID-19 ICU patients, these rates may vary depending on the institutional case mix and population risk profile [\u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e].\u003c/p\u003e\u003cp\u003eA critical challenge during the COVID-19 pandemic was hospital and ICU overcrowding, which emerged as a critical issue during the pandemic and was driven by prolonged hospital stays and limited bed turnover. In the present study, the average ICU length of stay was 13 days. A study from southern Brazil reported a median ICU stay of nine days among COVID-19 patients, corroborating our findings.\u003c/p\u003e\u003cp\u003eThe increased demand for ventilatory support during the pandemic, particularly invasive mechanical ventilation, necessitated the rapid expansion of respiratory care resources. In this study, the majority of ICU patients required invasive mechanical ventilation. A systematic review and meta-analysis revealed a 55.2% prevalence of invasive ventilation among COVID-19 ICU patients across the United States, United Kingdom, China, Mexico, France, and Italy [\u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e].\u003c/p\u003e\u003cp\u003eThe need for mechanical ventilation was significantly associated with AE occurrence, with patients requiring ventilation within the first 24 hours of ICU admission having a 2.16-fold greater risk of experiencing an AE. A systematic review and meta-analysis of COVID-19-related publications reported that one in three patients who underwent intubation experienced an AE [\u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e]. Furthermore, a cohort study of 12,723 COVID-19 ICU patients in 78 Dutch hospitals reported invasive ventilation rates of 58.1% during the first wave and 58.2% during the second wave of the pandemic, supporting the findings of the present study [\u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e].\u003c/p\u003e\u003cp\u003eAmong all reported safety incidents in this study, 60.96% resulted in patient harm. This rate is lower than that reported in a bulletin from the Health Surveillance Center of S\u0026atilde;o Paulo, which analyzed 35,751 incident reports during the pandemic and reported that 77.49% involved patient harm [\u003cspan citationid=\"CR14\" class=\"CitationRef\"\u003e14\u003c/span\u003e]. Despite their similar magnitude, few studies have evaluated AEs in terms of severity (e.g., no harm, harm, or near misses) and their relationship with patient outcomes during the pandemic.\u003c/p\u003e\u003cp\u003eThe institution where this study was conducted is characterized by a strong safety culture, which promotes learning not only from harmful events but also from near misses and no-harm incidents. Quality improvement is broadly integrated into the organization, involving all professionals in process optimization, reactive and proactive risk management, clinical protocols, and accreditation activities. Among the reported AEs, 4.49% were classified as severe. This figure is slightly higher than the 3.09% rate of severe harm incidents reported in the S\u0026atilde;o Paulo State bulletin, which analyzes pandemic-related safety incidents [\u003cspan citationid=\"CR14\" class=\"CitationRef\"\u003e14\u003c/span\u003e].\u003c/p\u003e\u003cp\u003eA study conducted in a Rio de Janeiro ICU prior to the pandemic reported that 59.3% of AEs were related to clinical procedures, followed by 24.4% involving medications or IV fluids [\u003cspan citationid=\"CR15\" class=\"CitationRef\"\u003e15\u003c/span\u003e]. Similar findings were reported in two hospitals in Rio Grande do Sul, Brazil, during the COVID-19 pandemic, with 41.6% of moderate or severe AEs involving clinical procedures and 33.6% involving medications or fluids [\u003cspan citationid=\"CR16\" class=\"CitationRef\"\u003e16\u003c/span\u003e].\u003c/p\u003e\u003cp\u003eIn terms of the AE categories, pressure injuries and device-related incidents were the most common. The frequent use of prone positioning to improve oxygenation in patients with respiratory failure, often for extended periods, may have contributed to pressure injuries. A Spanish study investigating AEs in mechanically ventilated patients in the prone position reported that 60.6% developed pressure injuries, particularly on the forehead, chin, nose, and cheekbones [\u003cspan citationid=\"CR17\" class=\"CitationRef\"\u003e17\u003c/span\u003e]. Similarly, a study from Tunisia reported that 18.5% of AEs in 10 ICUs were related to skin injuries [\u003cspan citationid=\"CR18\" class=\"CitationRef\"\u003e18\u003c/span\u003e]. National data from the Brazilian Health Regulatory Agency indicated that pressure injuries accounted for 27% of all reported incidents in S\u0026atilde;o Paulo during the pandemic [\u003cspan citationid=\"CR14\" class=\"CitationRef\"\u003e14\u003c/span\u003e].\u003c/p\u003e\u003cp\u003ePatients who experienced AEs had greater mortality and longer ICU stays than did those who did not. A United States cohort study across 29 hospitals revealed that patients with diagnostic errors had a 6.6% probability of death [\u003cspan citationid=\"CR19\" class=\"CitationRef\"\u003e19\u003c/span\u003e]. Another Canadian study of more than 17,000 ICU admissions revealed that patients who experienced AEs had higher mortality, more invasive interventions, longer hospital stays, and greater costs [\u003cspan citationid=\"CR20\" class=\"CitationRef\"\u003e20\u003c/span\u003e].\u003c/p\u003e\u003cp\u003eA Brazilian cohort study with a similar methodology conducted before the pandemic revealed that patients who experienced AEs had an average ICU stay of 19 days and were twice as likely to die as those who did not experience AEs [\u003cspan citationid=\"CR15\" class=\"CitationRef\"\u003e15\u003c/span\u003e].\u003c/p\u003e\u003cp\u003eIt is important to recognize the complex relationships among AE occurrence, patient severity, length of stay, and mortality. It remains unclear whether AEs are a consequence of greater severity or a contributing factor to it. This reflects the dynamic nature of healthcare as a complex adaptive system influenced by human factors and systemic interactions.\u003c/p\u003e\u003cp\u003eThis study also revealed a significant association between AE occurrence and the use of specific ICU resources, including mechanical ventilation, tracheostomy, vasopressors, renal replacement therapy, central venous catheters, indwelling urinary catheters, and invasive arterial pressure monitoring. A study conducted at a university hospital in S\u0026atilde;o Paulo reported a similar association between the use of vasoactive drugs, ventilator-associated pneumonia, and mortality in patients with AEs [\u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e]. Another study in Quito, Ecuador, reported greater use of central catheters, arterial lines, endotracheal tubes, tracheostomies, and gastric tubes among COVID-19 patients who experienced AEs than among those who did not [\u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e].\u003c/p\u003e\u003cp\u003eIn addition to incidence rates, the findings of this study offer critical insight into the experience of intensive care unit (ICU) care during a global health crisis. This study has several limitations. It did not compare AEs across different pandemic phases (e.g., first vs. second wave, pre- vs. postvaccination), which may have revealed organizational learning over time. Additionally, while the results are contextualized with data from other institutions, variations in safety culture and quality maturity may limit the generalizability of the findings.\u003c/p\u003e"},{"header":"Conclusions","content":"\u003cp\u003eThis study enabled the characterization of incident reports, which were predominantly related to harmful events, with a smaller proportion of no-harm incidents. The main types of incidents were classified as being associated with patient-related accidents, clinical procedures, and medical equipment. The most frequently reported categories were skin and soft tissue injuries, and events related to invasive and non-invasive devices. The associations observed between adverse events, length of ICU stay, mortality, and the use of intensive care resources suggest that such events have a significant effect on the outcomes of critically ill patients.\u003c/p\u003e"},{"header":"Abbreviations","content":"\u003cdiv class=\"DefinitionList\"\u003e\u003cdiv class=\"DefinitionListEntry\"\u003e\u003cdiv class=\"Term\"\u003eAE\u003c/div\u003e\u003cdiv class=\"Description\"\u003e\u003cp\u003eAdverse Events\u003c/p\u003e\u003c/div\u003e\u003c/div\u003e\u003cdiv class=\"DefinitionListEntry\"\u003e\u003cdiv class=\"Term\"\u003eSAPS 3\u003c/div\u003e\u003cdiv class=\"Description\"\u003e\u003cp\u003eSimplified Acute Physiology Score 3\u003c/p\u003e\u003c/div\u003e\u003c/div\u003e\u003cdiv class=\"DefinitionListEntry\"\u003e\u003cdiv class=\"Term\"\u003eSOFA\u003c/div\u003e\u003cdiv class=\"Description\"\u003e\u003cp\u003eSequential Organ Failure Assessment\u003c/p\u003e\u003c/div\u003e\u003c/div\u003e\u003cdiv class=\"DefinitionListEntry\"\u003e\u003cdiv class=\"Term\"\u003eICU\u003c/div\u003e\u003cdiv class=\"Description\"\u003e\u003cp\u003eIntensive Care Unit\u003c/p\u003e\u003c/div\u003e\u003c/div\u003e\u003c/div\u003e"},{"header":"Declarations","content":"\u003cp\u003e\u003cstrong\u003eEthics approval and consent to participate\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eExemption from the informed consent form was granted owing to the observational and epidemiological nature of the study. The researcher signed a data confidentiality agreement. \u0026nbsp;The research was conducted in accordance with relevant regulations and guidelines, including the Declaration of Helsinki. Ethical permission was obtained from Research Ethics Committee of the Hospital Alemão Oswaldo Cruz, São Paulo, SP, Brazil.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eConsent for publication\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eNot applicable\u003cstrong\u003e.\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAvailability of data and materials\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe data that support the findings of this study are available from Hospital Alemão Oswaldo Cruz, but restrictions apply to the availability of these data, which were used under license for the current study and are not publicly available. However, data may be made available from the authors upon reasonable request and with permission from Hospital Alemão Oswaldo Cruz.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eCompeting interests\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe authors declare that they have no competing interests.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eFunding\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThis research received no specific grant from any funding agency in the public, commercial, or not-for-profit sectors.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAuthors’ contributions\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eGSZ and EB contributed to the conception of the study, data analysis and interpretation, manuscript drafting, and critical revision of its intellectual content. GCSG contributed to manuscript drafting and critical revision of its intellectual content. All authors read and approved the final manuscript\u003cstrong\u003e.\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAcknowledgement\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eWe would like to thank Hospital Alemão Oswaldo Cruz for the technological and epidemiological support provided during the data collection process\u003cstrong\u003e.\u003c/strong\u003e\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\n\u003cli\u003eBates DW, Singh H. Two Decades Since To Err Is Human: an Assessment of Progress and Emerging Priorities in Patient Safety. Health Aff (Millwood). 2018; 37(11): 1736-43. doi: 10.1377/hlthaff.2018.0738. \u003c/li\u003e\n\u003cli\u003eMonti M, Coppolaro A, Guarnieri S. Mapping strategies for strengthening safety culture: a scoping review. Healthcare (Basel). 2024;12(12):1194. doi:10.3390/healthcare12121194\u003c/li\u003e\n\u003cli\u003eMartins C, Costa JA, Oliveira IBA, Lenhardt MM, Silva MS, Borges CD et al. Difficulties and challenges faced by the nursing team in the scenario of the COVID-19 pandemic. Research, Society and Development, 2022; 11(6): e4311627150. doi: 10.33448/rsd-v11i6.27150.\u003c/li\u003e\n\u003cli\u003eYesudhas D, Srivastava A, Gromiha MM. COVID-19 outbreak: history, mechanism, transmission, structural studies and therapeutics. Infection. 2021 Apr;49(2):199-213. doi: 10.1007/s15010-020-01516-2\u003c/li\u003e\n\u003cli\u003eRafael RMR, Neto M, Carvalho MMB, David HMSL, Acioli S, Faria MGA. Epidemiologia, pol\u0026iacute;ticas p\u0026uacute;blicas e Covid-19: o que esperar no Brasil? Rev enferm UERJ. 2020; 28:e49570. doi: 10.12957/reuerj.2020.49570\u003c/li\u003e\n\u003cli\u003eMurata M, Nakagawa N, Kawasaki T, Yasuo S, Yoshida T, Ando K et al. Adverse events during intrahospital transport of critically ill patients: A systematic review and meta-analysis. Am J Emerg Med. 2022; 52:13-19. doi: 10.1016/j.ajem.2021.11.021.\u003c/li\u003e\n\u003cli\u003eMart\u0026iacute;nez Sosa D, Ruilova M, Hoyos JA, Vargas-Alzate C, Vanegas JM. Adverse events during the COVID-19 pandemic in Ecuador: high frequency of healthcare-associated infections and increasing hospital stay and costs. Infect Prev Pract. 2023; 5(4):100302. doi: 10.1016/j.infpip.2023.100302\u003c/li\u003e\n\u003cli\u003eKartsonaki C, Baillie JK, Barrio NG, Baruch J, Beane A, Blumberg L et al. Characteristics and outcomes of an international cohort of 600 000 hospitalized patients with COVID-19. Int J Epidemiol. 2023; 52(2):355-376. doi: 10.1093/ije/dyad012. \u003c/li\u003e\n\u003cli\u003ePeltan ID, Caldwell E, Admon AJ, Attia EF, Gundel SJ, Mathews KS et al. Characteristics and Outcomes of US Patients Hospitalized With COVID-19. Am J Crit Care. 2022; 31(2):146-157. doi: 10.4037/ajcc2022549\u003c/li\u003e\n\u003cli\u003eLuz MV, Silva JF, Ceccato HD, de Souza J\u0026uacute;nior PJ, Villar PM, Mendes PRA et al. Cohort study of hospitalized patients with COVID-19 at Brazilian tertiary-care hospital: Occurrence of adverse events and mortality. Braz J Infect Dis. 2023; 27(4):102791. doi: 10.1016/j.bjid.2023.102791\u003c/li\u003e\n\u003cli\u003eChang R, Elhusseiny KM, Yeh YC, Sun WZ. COVID-19 ICU and mechanical ventilation patient characteristics and outcomes-A systematic review and meta-analysis. PLoS One. 2021; 16(2):e0246318. doi: 10.1371/journal.pone.0246318.\u003c/li\u003e\n\u003cli\u003eDowning J, Yardi I, Ren C, Cardona S, Zahid M, Tang K et al. Prevalence of peri-intubation major adverse events among critically ill patients: A systematic review and meta-analysis. Am J Emerg Med. 2023; 71:200-216. doi: 10.1016/j.ajem.2023.06.046.\u003c/li\u003e\n\u003cli\u003eDongelmans DA, Termorshuizen F, Brinkman S, Bakhshi-Raiez F, Arbous MS, de Lange DW et al. Characteristics and outcome of COVID-19 patients admitted to the ICU: a nationwide cohort study on the comparison between the first and the consecutive upsurges of the second wave of the COVID-19 pandemic in the Netherlands. Ann Intensive Care. 2022; 12(1):5. doi: 10.1186/s13613-021-00978-3.\u003c/li\u003e\n\u003cli\u003eSecretaria do Estado de S\u0026atilde;o Paulo. Coordenadoria de Controle de Doen\u0026ccedil;as, Centro de Vigil\u0026acirc;ncia Sanit\u0026aacute;ria. Perfil dos eventos notificados e das pr\u0026aacute;ticas de seguran\u0026ccedil;a do paciente no Estado de S\u0026atilde;o Paulo no ano de 2021. S\u0026atilde;o Paulo: SES/CVS, 2023. 120p. Available from: https://proqualis.fiocruz.br/sites/proqualis.fiocruz.br/files/Relat%C3%B3rio%20Seguranc%CC%A7a%20do%20Paciente.pdf \u003c/li\u003e\n\u003cli\u003eRoque KE, Tonini T, Melo EC. Adverse events in the intensive care unit: impact on mortality and length of stay in a prospective study. Cad Saude Publica. 2016; 32(10):e00081815. doi: 10.1590/0102-311X00081815\u003c/li\u003e\n\u003cli\u003eLima GO, Borges AR, Sakamoto VTM, Florentino JR, Jardim ALP, Silveira MS et al. Moderate and severe adverse events in pediatrics: characteristics of incidents reported during the COVID-19 pandemic. Rev Gaucha Enferm. 2024; 45: e20230020. doi: 10.1590/1983-1447.2024.20230020.en.\u003c/li\u003e\n\u003cli\u003eRodr\u0026iacute;guez-Huerta MD, D\u0026iacute;ez-Fern\u0026aacute;ndez A, Rodr\u0026iacute;guez-Alonso MJ, Robles-Gonz\u0026aacute;lez M, Mart\u0026iacute;n-Rodr\u0026iacute;guez M, Gonz\u0026aacute;lez-Garc\u0026iacute;a A. Nursing care and prevalence of adverse events in prone position: Characteristics of mechanically ventilated patients with severe SARS-CoV-2 pulmonary infection. Nurs Crit Care. 2022; 27(4):493-500. doi: 10.1111/nicc.12606\u003c/li\u003e\n\u003cli\u003eTlili MA, Aouicha W, Gambashidze N, Ben Cheikh A, Sahli J, Weigl M et al. A retrospective analysis of adverse events reported by Tunisian intensive care units\u0026apos; professionals. BMC Health Serv Res. 2024; 24(1):77. doi: 10.1186/s12913-024-10544-9.\u003c/li\u003e\n\u003cli\u003eAuerbach AD, Lee TM, Hubbard CC, Ranji SR, Raffel K, Valdes G et al. Diagnostic Errors in Hospitalized Adults Who Died or Were Transferred to Intensive Care. JAMA Intern Med. 2024; 184(2):164-173. doi: 10.1001/jamainternmed.2023.7347\u003c/li\u003e\n\u003cli\u003eCantor N, Durr KM, McNeill K, Thompson LH, Fernando SM, Tanuseputro P et al. Increased Mortality and Costs Associated with Adverse Events in Intensive Care Unit Patients. J Intensive Care Med. 2022; 37(8):1075-81. doi: 10.1177/08850666221084908\u003c/li\u003e\n\u003c/ol\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":false,"hideJournal":false,"highlight":"","institution":"","isAcceptedByJournal":false,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"bmc-health-services-research","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"bhsr","sideBox":"Learn more about [BMC Health Services Research](http://bmchealthservres.biomedcentral.com/)","snPcode":"","submissionUrl":"https://www.editorialmanager.com/BHSR/default.aspx","title":"BMC Health Services Research","twitterHandle":"BMC_series","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"em","reportingPortfolio":"BMC Series","inReviewEnabled":true,"inReviewRevisionsEnabled":true},"keywords":"Patient Safety, Intensive Care Units, Health Information Systems, Risk Management, COVID‑19","lastPublishedDoi":"10.21203/rs.3.rs-7536535/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-7536535/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003cp\u003e\u003cstrong\u003eBackground: \u003c/strong\u003eThe COVID-19 pandemic has placed an unprecedented burden on intensive care units (ICU), increasing patient vulnerability to adverse events (AEs). This study aimed to analyze the occurrence of AEs, their characteristics, and associations with clinical outcomes and resource utilization among ICU patients.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eMethods: \u003c/strong\u003eA retrospective observational cohort study was conducted in a private tertiary hospital in São Paulo, Brazil. Data from ICU admissions between March 2020 and July 2021 were analyzed. The study included patients ≥17 years old with a confirmed COVID-19 diagnosis. Data on demographics, clinical scores, AE occurrence, ICU outcomes, and device usage were collected and analyzed using descriptive statistics and appropriate inferential tests.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eResults:\u003c/strong\u003e Among the 1,226 patients admitted to the ICU, 25.2% experienced at least one AE. Most patients were male (68.8%) with a mean age of 64.1 years. The ICU mortality rate was 19.1%, and the hospital mortality rate was 24.2%. Patients with AEs had a significantly longer ICU length of stay (mean 23.8 ± 22.3 vs. 9.8 ± 9.9 days), higher Charlson Comorbidity Index, Simplified Acute Physiology Score III and Sequential Organ Failure Assessment scores, and standardized mortality ratios (p \u0026lt; 0.001 for all comparisons). Most AEs involved harm (60.96%), primarily mild (86.5%), with skin/soft tissue injuries and device-related incidents being the most common categories. AE occurrence was significantly associated with increased use of invasive interventions, including mechanical ventilation (OR 6.71), vasopressors (OR 2.88), and central venous catheters (OR 4.25)\u003cstrong\u003e.\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eConclusions: \u003c/strong\u003eAE occurrence was frequent among ICU patients with COVID-19 and was significantly associated with longer ICU stays, higher mortality, and greater use of critical care resources. These findings underscore the importance of targeted strategies to reduce AEs in high-acuity settings.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eTrial registration: \u003c/strong\u003eNot applicable.\u003c/p\u003e","manuscriptTitle":"Patient Safety Incidents in an Intensive Care Unit during the COVID‑19 Pandemic: A Retrospective Cohort Study","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2025-10-17 09:23:44","doi":"10.21203/rs.3.rs-7536535/v1","editorialEvents":[{"type":"communityComments","content":0},{"type":"editorInvitedReview","content":"","date":"2025-10-27T17:48:40+00:00","index":"hide","fulltext":""},{"type":"reviewerAgreed","content":"314048786910264249465261505506628797853","date":"2025-10-18T16:38:45+00:00","index":"hide","fulltext":""},{"type":"reviewersInvited","content":"","date":"2025-10-06T13:01:47+00:00","index":"","fulltext":""},{"type":"editorAssigned","content":"","date":"2025-10-01T09:37:09+00:00","index":"","fulltext":""},{"type":"editorInvited","content":"","date":"2025-09-12T10:40:34+00:00","index":"","fulltext":""},{"type":"checksComplete","content":"","date":"2025-09-11T14:44:58+00:00","index":"","fulltext":""},{"type":"submitted","content":"BMC Health Services Research","date":"2025-09-11T14:41:53+00:00","index":"","fulltext":""}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"bmc-health-services-research","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"bhsr","sideBox":"Learn more about [BMC Health Services Research](http://bmchealthservres.biomedcentral.com/)","snPcode":"","submissionUrl":"https://www.editorialmanager.com/BHSR/default.aspx","title":"BMC Health Services Research","twitterHandle":"BMC_series","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"em","reportingPortfolio":"BMC Series","inReviewEnabled":true,"inReviewRevisionsEnabled":true}}],"origin":"","ownerIdentity":"3d365717-c4ae-48a9-a56e-7c8fb00a521f","owner":[],"postedDate":"October 17th, 2025","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"under-review","subjectAreas":[],"tags":[],"updatedAt":"2025-10-17T09:23:44+00:00","versionOfRecord":[],"versionCreatedAt":"2025-10-17 09:23:44","video":"","vorDoi":"","vorDoiUrl":"","workflowStages":[]},"version":"v1","identity":"rs-7536535","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-7536535","identity":"rs-7536535","version":["v1"]},"buildId":"8U1c8b4HqxoKbykW_rLl7","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}