Ventilation Strategies for Weaning from Prolonged Mechanical Ventilation in Pediatric Intensive Care Units in Mainland China

Objective: To describe ventilation strategies for weaning patients from prolonged mechanical ventilation (PMV) in Pediatric Intensive Care Units (PICUs). Method: Conducted a retrospective study across eleven PICUs in mainland China from January 1, 2021, to December 31, 2022. Results: 234 patients diagnosed with PMV were included in the study. Weaning Outcomes: 42.3% (99 patients) successfully weaned and extubated. 15.8% (37 patients) required only a tracheostomy. 9.8% (23 patients) needed non-invasive ventilation. 32.1% (75 patients) continued to require mechanical ventilation. 34.2% (80 patients) on invasive pressure control mode at PMV diagnosis. Pressure control was the most commonly used method. Synchronized intermittent mandatory ventilation (SIMV) used by 30.4% (71 patients). Pressure support ventilation (PSV) used by 5.1% (12 patients). 63.2% (148 patients) received physiotherapy. 44.9% (105 patients) received cough augmentation techniques. 26.9% (63 patients) underwent tracheostomy after an average of 29 days of invasive mechanical ventilation. Higher fraction of inspired oxygen (FiO 2 ) linked to weaning failure (HR=1.025). Sedation on PMV diagnosis day linked to weaning success (HR=0.392). Presence of tracheostomy associated with weaning success (HR=0.435). Patients with lower airway diseases had better weaning outcomes compared to those with central nervous system diseases (HR=0.484). Conclusion: Pressure control ventilation was the initial mode; SIMV and PSV were preferred for weaning. Higher FiO 2 on the day of the PMV diagnosis was associated with weaning failure, while sedation and tracheostomy were likely linked to weaning success. Lower airway diseases showing better outcomes than central nervous system diseases. Ventilation Strategies for Weaning from Prolonged Mechanical Ventilation in Pediatric Intensive Care Units in Mainland China Tian Li 1#, Zhengzheng Zhang 2#,Hong Ren 3, Chengjun Liu 4, Zihao Yang 5,Yibing Cheng 6, Wei Xu 7,Dong Qu 8, Hengmiao Gao 9, Furong Zhang 10, Hongjun Miao 11, Feng Ye 1, Musheng Li 1, Jianhui Zhang 1, Jianping Tao 1, Weiming Chen 2 *,Li Huang 12 * 1.Pediatric Intensive Care Unit, National Children’s Medical Centerr for South Central Region, Guangzhou Women and Children’s Medical Center, Affiliated Hospital of Guangzhou Medical University, Guangzhou, China. 2.Pediatric Intensive Care Unit, National Children’s Medical Center. Children’s Hospital of Fudan University, Shanghai, China. 3.Department of Pediatric Intensive Care Unit, National Children’s Medical Center, Shanghai Children’s Medical Center, Shanghai Jiaotong University School of Medicine, Shanghai, China. 4.Department of Pediatric Intensive Care Unit, Western Pediatric Development Union, Children’s Hospital of Chongqing Medical University, Chongqing, China. 5.Department of Pediatric Intensive Care Unit, National Clinical Research Center for Child Health, Children’s Hospital of Zhejiang University School of Medicine, Hangzhou, Zhejiang, China. 6.Department of Pediatric Intensive Care Unit, Children’s Hospital Affiliated to Zhengzhou University, Zhengzhou, China. 7.Department of pediatric intensive care unit, National Children’s (Northeast) Regional Medical Center, Shengjing Hospital of China Medical University, Shenyang, China. 8.Department of Pediatric Intensive Care Unit, Childre’s hospital, Capital Institute of Pediatrics, Beijing, China. 9. Department of Pediatric Intensive Care Unit, National Center for Children’s Health, Beijing Children’s hospital, Capital Medical University, Beijing, China. 10. Department of Pediatric Intensive Care Unit, Wuhan Children’s Hospital, Tongji Medical College, Huazhong University of Science & Technology, Wuhan, Hubei, China. 11. Department of Emergency / Critical Medicine, Children’s Hospital of Nanjing Medical University, Nanjing, Jiangsu, China. 12. Department of Emergency, National Children’s Medical Centerr for South Central Region, Guangzhou Women and Children’s Medical Center, Affiliated Hospital of Guangzhou Medical University, Guangzhou, China. #These authors contributed equally to this work Corresponding author: *Weiming Chen, 18017590893, E-mail: [email protected] *Li Hang, 13903055297, E-mail: [email protected]

Objective: To describe ventilation strategies for weaning patients from prolonged mechanical ventilation (PMV) in Pediatric Intensive Care Units (PICUs).

Conducted a retrospective study across eleven PICUs in mainland China from January 1, 2021, to December 31, 2022.

234 patients diagnosed with PMV were included in the study. Weaning Outcomes: 42.3% (99 patients) successfully weaned and extubated. 15.8% (37 patients) required only a tracheostomy. 9.8% (23 patients) needed non-invasive ventilation. 32.1% (75 patients) continued to require mechanical ventilation. 34.2% (80 patients) on invasive pressure control mode at PMV diagnosis. Pressure control was the most commonly used method. Synchronized intermittent mandatory ventilation (SIMV) used by 30.4% (71 patients). Pressure support ventilation (PSV) used by 5.1% (12 patients). 63.2% (148 patients) received physiotherapy. 44.9% (105 patients) received cough augmentation techniques. 26.9% (63 patients) underwent tracheostomy after an average of 29 days of invasive mechanical ventilation. Higher fraction of inspired oxygen (FiO 2 ) linked to weaning failure (HR=1.025). Sedation on PMV diagnosis day linked to weaning success (HR=0.392). Presence of tracheostomy associated with weaning success (HR=0.435). Patients with lower airway diseases had better weaning outcomes compared to those with central nervous system diseases (HR=0.484).

Pressure control ventilation was the initial mode; SIMV and PSV were preferred for weaning. Higher FiO 2 on the day of the PMV diagnosis was associated with weaning failure, while sedation and tracheostomy were likely linked to weaning success. Lower airway diseases showing better outcomes than central nervous system diseases.

Prolonged mechanical ventilation, extended weaning, pediatric intensive care unit, ventilation strategies, tracheostomy. Funding source The national key research and development program of China (2021YFC2701800, 2021YFC2701805) Shanghai Municipal Health System key supporting discipline projects（2023ZDFC0103）

With advancements in medical technology, an increasing number of patients are surviving in the pediatric intensive care unit (PICU). However, some of these patients may not fully recover and may require life support equipment, such as mechanical ventilators, for extended periods. This presents a significant challenge for critical care providers and families worldwide 1-3 . In developed Western countries, children who are dependent on technology often receive care from home care nurses and social workers, along with support from the community and government. In contrast, this model of child life support has not been widely implemented in mainland China. In China, critically ill children who are still on ventilators but in relatively stable condition are typically transferred to national or regional children’s medical centers for further treatment. However, none of these PICUs permit family members to accompany their children, and there are no alternative units available to care for these ventilator-dependent patients. The PICU is the only facility where families can remain with their children. Some families may opt to discontinue treatment due to financial constraints. However, an increasing number of families are choosing home ventilation to facilitate their children’s reintegration into family life and society. However, there is limited data available regarding patients requiring prolonged mechanical ventilation (PMV) nationwide, and follow-up studies are scarce. In this context, our multicenter collaborative group was established to further investigate medical management strategies and outcomes for children with PMV. This includes examining factors such as mechanical ventilation modes and settings, physiotherapy, tracheostomy, and other interventions, with the aim of improving outcomes for this population. Study design This study was a multicenter retrospective cohort study, initially approved by the Institutional Review Board of the National Children’s Medical Center at Fudan University [No.(2020)475]. For retrospective analysis of desensitized data, the study received an exemption from informed consent from the IRB. The study protocol was registered at Clinicaltrial.gov NCT04511741. Eleven tertiary PICUs of eight major cities in mainland China participated in the survey: Beijing, Shanghai, Guangzhou, Chongqing, Hangzhou, Zhengzhou, Wuhan, and Nanjing. Among these, two were designated as national children’s medical centers, while four were classified as regional children’s medical centers. Definitions PMV was defined according to the National Association of Medical Direction of Respiratory Care (NAMDRC) definition 4, which was 21 consecutive days of ventilation for more than 6 hours per day considering invasive and noninvasive ventilation duration and including short interruptions (48h) or a progressive radiographic infiltrate plus two of the following: temperature of >38℃or degradation. Spontaneous breathing trial (SBT) was conducted using a T-piece, continuous positive airway pressure (CPAP), or pressure support (PS) for a duration of at least 30 minutes and no longer than 120 minutes. The criteria for a successful SBT was respiratory rate, heart rate, and blood pressure within the normal range or less than a 20% change from baseline, saturation >90% on FiO 2 <40%, no signs of increased work of breathing. Data collection From January 1, 2021, to December 31, 2022, we retrospectively included all patients with PMV who were admitted to PICUs. Inclusion criteria: (1)aged between 28 days and 18 years; (2) met the definition of PMV. The exclusion criteria were: (1) patients who died during their PICU stay; (2) patients who had their treatment withdrawn for any reason. One clinician at each unit was trained to collect information and enter it into an online database. The information collected included: (1) demographic information such as, age, gender, and weight; (2) the admitting diagnosis and the causes of ventilator dependence, which included central nervous system diseases, neuromuscular disorders, upper airway diseases, lower airway diseases, cardiovascular diseases, and others; (3) the ventilator mode and settings on the day that met the definition of PMV, as well as at 14, 28, and 60 days thereafter until PICU discharge; (4) the occurrence of VAP during the PICU stay; (5) the time to tracheostomy; and (6) adjunctive therapies, including sedation (any type of sedative or pain control medication), paralysis, vasoactive drug infusion (including epinephrine, norepinephrine, dopamine, dobutamine, and milrinone), physiotherapy (including passive movements, active exercises, and extracorporeal diaphragmatic electrical stimulation), and airway clearance techniques (such as hypertonic saline, postural drainage and percussion, and cough augmentation techniques). Statistical analysis All statistical analyses were conducted using SPSS version 24.0 (SPSS, Chicago, IL). Descriptive statistics were summarized for the entire study population as well as for subgroups. Patient characteristics were presented as counts and percentages, while continuous variables that were not normally distributed were summarized using the median and interquartile range (IQR). The Chi-squared test was employed for categorical variables. The Mann-Whitney U test or Kruskal-Wallis rank test was utilized for two-sample or multi-sample continuous data that did not follow a normal distribution. Cox regression analyses were performed to evaluate the relationships between variables and outcomes. The hazard ratio and confidence interval were reported for each variable. A p-value of less than 0.05 was considered statistically significant for all analyzed parameters.

Characteristics and Outcomes of PMV Patients A total of 314 patients met the PMV diagnosis during the study period. Of these, 46 patients died, and 34 patients withdrew from the PICU (see Fig. 1). By the time of discharge from the PICU, 136 patients (58.1%) had been successfully weaned from invasive mechanical ventilation. This group included 99 patients who required no respiratory support and 37 patients who needed only tracheostomy. However, 98 patients (41.9%) still required mechanical ventilation. Among these, 23 patients were decannulated and needed non-invasive ventilation, while 75 patients were transferred to a recovery center, community hospital, hospice unit, or home, remaining on full-time invasive mechanical ventilation. The characteristics and data of PMV patients are presented in Table 1. The average age of PMV patients was 31.5 months, with 56.4% being male. Central nervous system diseases (97 patients, 41.5%) were the primary cause of ventilator dependence, followed by lower airway diseases (73 patients, 31.2%) and neuromuscular disorders (37 patients, 15.8%). The average duration of ventilation is illustrated in Fig. 2. Figure 1. Flow Chart Figure 2. Duration of Mechanical Ventilation in Children with PMV of Varying Causes Ventilation Strategies for PMV Patients Before the day of PMV diagnosis, the most common ventilation mode was pressure control (162 patients, 69.2%). Fifteen patients (6.4%) received high-frequency oscillatory ventilation (HFOV), and two patients received neurally adjusted ventilatory assist (NAVA). Only one patient did not receive invasive mechanical ventilation. Two units preferred synchronized intermittent mandatory ventilation (SIMV) as the initial ventilation mode, while the other nine units favored control modes, particularly pressure control. There were a total of 81 patients (34.6%) who underwent a SBT prior to the diagnosis of PMV, and 36 patients (44.4%) underwent the trial more than once. On average, 1 SBT (range: 1-2) was performed per patient. A total of 77 patients attempted extubation; however, 60 of these patients (77.9%) failed and required reintubation within 48 hours. Additionally, there were 5 patients who extubated without undergoing an SBT. On the day of PMV diagnosis, 110 patients (47.0%) were still on the invasive-control mode of ventilation, with pressure control being the most commonly used mode (80 patients, 34.2%). SIMV and PSV were the most popular strategies employed to shorten ventilation, accounting for 71 patients (30.4%) and 12 patients (5.1%), respectively. Additionally, 24 patients (10.3%) were receiving non-invasive ventilation. Ventilation settings showed no significant differences between the weaning success and failure groups, except for FiO 2, which was significantly higher in the weaning failure group (40% [30-35%] vs. 35% [30-40%], P=0.022). Furthermore, 61.1% of patients were using sedative drugs, with a significantly higher percentage in the weaning success group compared to the weaning failure group. Additionally, 11.5% of patients were on at least one vasoactive drug infusion. Overall, 63.2% of patients with PMV received physiotherapy, which included passive limb movements (136/148), active limb exercises (5/148), muscle electrical stimulation (26/148), and respiratory muscle training (25/148). Additionally, 91.9% of patients underwent airway clearance techniques, including hypertonic saline (107/215), postural drainage and percussion (174/215), and cough assist techniques (105/215). The incidence of VAP during the stay in the PICU was 32.1%. Tracheostomy A total of 63 patients underwent tracheostomy (Table 2). The median age of these patients was 60 months (range: 25-114 months), which was significantly older than the median age of those who did not receive a tracheostomy, which was 25 months (range: 5-77 months), with a p-value of <0.001. Among the patients who received tracheostomy, 55 (87.3%) had central nervous system (CNS) or neuromuscular diseases. The median time from the initiation of mechanical ventilation to the tracheostomy procedure was 29 days (range: 16-39 days). In comparison to patients who did not undergo tracheostomy, those who did required less sedation (42.9% vs. 67.8%, p=0.001) and fewer vasoactive drugs (3.2% vs. 14.6%, p=0.015). Additionally, they received more physiotherapy (84.1% vs. 55.6%, p<0.001) and had a longer length of stay in the PICU (median of 54 days [range: 40-81 days] vs. 39 days [range: 29-53 days], p<0.001). We further divided the tracheostomy patients into two groups based on the timing of their tracheostomy (Table 3). Patients who received a tracheostomy within three weeks had a shorter stay in the PICU. In the Cox regression analyses (Table 4), weaning failure was associated with the fraction of inspired oxygen on the day of PMV diagnosis (HR = 1.025, 95% CI: 1.007-1.043), sedation on the day of PMV diagnosis (HR = 0.392, 95% CI: 0.247-0.621), and tracheostomy (HR = 0.435, 95% CI: 0.258-0.734). Patients with lower airway diseases experienced easier weaning compared to those with central nervous system diseases (HR = 0.484, 95% CI: 0.249-0.939).

This is a retrospective study examining ventilation strategies for weaning patients with PMV across multiple national and regional children’s medical centers in mainland China, utilizing a representative sample of cases. The definition of PMV in children varies 6 ; however, we have chosen to use the NAMDRC definition for comparison. Among the patients with PMV, 14.6% (46 out of 314) died in the PICU, which is comparable to the 15.9% mortality rate reported in China from 2017 to 2019 10, but significantly lower than the 29% reported in a previous review 2 . This lower mortality rate may be attributed to the fact that these ventilator-dependent patients received continuous intensive care in the PICU. We included only survivors in our study of ventilation strategies for weaning. Our findings indicated that 58.1% (136 out of 234) of the patients were successfully weaned from mechanical ventilation prior to their discharge from the PICU. This result is comparable to the 50% weaning rate observed before discharge from the hospital in a meta-analysis of adult patients 7 . Among all study populations, the highest proportion of cases requiring PMV was attributed to central nervous system (CNS) diseases (41.5%), followed by lower airway diseases (31.2%). In European and American countries 8,9, the proportion of delayed withdrawal of treatment due to neuromuscular diseases and congenital metabolic disorders was the highest. However, in China, due to unique social and medical conditions, a significant number of patients with congenital diseases opted for immediate withdrawal of treatment following diagnosis. Compared to China’s data from 2017 to 2019 10, the proportion of PMV attributed to lower airway diseases exhibited a downward trend, decreasing from 41.6% to 31.2%. This decline may be attributed to several factors. First, the COVID-19 pandemic prompted the implementation of stringent national control policies, including mandatory mask-wearing, which contributed to a reduction in the overall incidence of respiratory infectious diseases. Second, advancements in the diagnosis and treatment of respiratory diseases, along with an improved understanding of mechanical ventilation and programmed weaning strategies, have facilitated earlier extubation for many children suffering from lower airway diseases. Additionally, many children’s hospitals have established separate cardiac intensive care units (CICUs), which were not included in our study; consequently, the proportion of cardiovascular diseases accounted for only 4.7%. We surveyed the ventilation strategies employed for patients with PMV and compared our findings to those from several years ago 10 . We discovered that all patients received invasive mechanical ventilation, except for one patient who only received non-invasive ventilation. Most units preferred control modes, particularly pressure control, while only two of the eleven units opted for SIMV mode as the initial choice. By the 21st day of ventilation, 47% of patients remained on control mode. When considering weaning from mechanical ventilation, the strategies employed included SIMV, PSV, and CPAP. Prior to extubation, only 34.6% of patients underwent a SBT. This low percentage may be attributed to the high prevalence of central nervous system and neuromuscular diseases among the patients. Non-invasive ventilation was frequently utilized to prevent or manage post-extubation respiratory failure in high-risk patients. Due to the retrospective nature of this study and the lack of standardized weaning protocols across different units, we were unable to determine which approach was superior to the others. NAVA has been implemented in recent years, and research in adults has shown that NAVA improves diaphragm efficiency, unlike PSV 11 . However, only two patients in our study received NAVA. The advantages and disadvantages of NAVA, as well as its potential to shorten ventilation time, still require further investigation in pediatric patients. Early mobilization and physiotherapy 12 are crucial adjunctive therapies that play significant roles in successful weaning. The ATS/CHEST guidelines recommend initiating mobilization as early as 24 hours after ventilation in adults 13 . During ventilation, 63.2% of patients received physiotherapy, with the majority undergoing passive limb movements; only five patients participated in active exercises. Additionally, the case report form we designed did not capture the initial timing and frequency of mobilization, which hindered our ability to identify differences between the weaning success and failure groups. However, in the tracheostomy group, the proportion of patients receiving physiotherapy was considerably higher, likely due to 87.3% of these patients having central nervous system and neuromuscular diseases. In the absence of physiotherapists, these patients were more likely to receive physiotherapy. Since a strong cough can predict extubation success and may reduce ICU length of stay and mortality 14, cough augmentation techniques are employed to facilitate extubation 15 . However, the results indicate that these techniques seem to have no effect on weaning. In our study, tracheostomy was performed on 26.9% of the patients requiring PMV, which is comparable to Cinotti’s report 16 of 25.6%, although they defined PMV as lasting more than 10 days. Half of the tracheostomies (32 out of 63) were conducted in two PICUs in Shanghai. In China, parental decision-making regarding long-term ventilation is influenced by various factors, including national healthcare policies, economic conditions, uncertain prognoses, and psychological stress. These factors complicate the decision-making process for parents 17 . In Shanghai, an international metropolis, both healthcare providers and family members demonstrate a higher acceptance of tracheostomy compared to other regions in China. Additionally, Shanghai benefits from relatively higher economic levels, better medical insurance, and stronger community support, contributing to the increased proportion of tracheostomy procedures performed. The average time to perform a tracheostomy was 29 days after the initiation of mechanical ventilation, significantly longer than the 10-12 days reported for adults 18,19 and also longer than our data from 2017-2019, which indicated an average of 21 days 10 . In pediatric patients, this duration is considered a late tracheostomy, regardless of the definitions of early tracheostomy, which are defined as occurring before 7 days of intubation according to Holscher et al. 20 or within 14 days as per Lee et al. 21 . Both of these studies suggested that early tracheostomy reduces the use of sedatives and shortens the length of stay in the PICU, although they found no impact on the incidence of hospital-acquired pneumonia. In our study, all tracheostomies were classified as late, and the length of stay in the PICU was significantly longer for the tracheostomy group. However, among tracheostomy patients, those who underwent the procedure within three weeks had a shorter PICU stay compared to those who had late tracheostomies. This discrepancy may be partly attributed to epidemic prevention and control policies that limited the flow of patients, as well as the absence of specialized units for stable patients. Families of these patients spent considerable time in the PICU to receive training in necessary knowledge and skills before returning home or to rehabilitation centers. Our study suggests that the causes of ventilator dependence, including FiO 2 levels and sedation on the day of PMV diagnosis, as well as tracheostomy, are associated with weaning outcomes. Central nervous system (CNS) diseases were identified as the most common cause of PMV. In comparison to this subgroup, patients with lower airway diseases had a 0.484 times higher risk of weaning failure. It is understandable that CNS diseases require a longer recovery time. On the day of PMV diagnosis, each 1% increase in FiO 2 was associated with a 2.5% increase in the risk of weaning failure. As a retrospective study, our data collection from case records is inadequate. Nevertheless, this study can represent the current status of children on PMV in mainland China. There are still unresolved questions that need to be addressed through well-designed multicenter clinical randomized controlled trials (RCTs) examining various protocols for weaning strategies, physiotherapy, tracheostomy, and other related interventions. Specialized weaning centers should be established by governments and healthcare providers.

In our multicenter retrospective study, the characteristics of pediatric patients requiring PMV who survived in the PICU showed minimal variation. The most common cause of ventilator dependence was central nervous system diseases. The proportion of successful weaning in the ICU was low, and management strategies—including ventilation mode, the weaning process, and the timing of extubation and tracheostomy—varied significantly. A higher fraction of inspired oxygen (FiO 2 ) on the day of PMV diagnosis was associated with weaning failure, while sedation on the day of PMV diagnosis and the presence of a tracheostomy were likely linked to weaning success. Patients with lower airway diseases experienced easier weaning compared to those with central nervous system diseases.

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Authors Metrics & Citations Metrics Article Usage 213views 229downloads Citations Download citation Tian Li, Zhang Zhengzheng, Ren Hong, et al. Ventilation Strategies for Weaning from Prolonged Mechanical Ventilation in Pediatric Intensive Care Units in Mainland China. Authorea. 26 February 2025. DOI: https://doi.org/10.22541/au.174060004.40557242/v1 DOI: https://doi.org/10.22541/au.174060004.40557242/v1 If you have the appropriate software installed, you can download article citation data to the citation manager of your choice. Simply select your manager software from the list below and click Download. For more information or tips please see 'Downloading to a citation manager' in the Help menu.