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There are many types of airway masks which differ in materials and effectiveness. This study aims to evaluate the effect of a surgical mask, the N95 mask, and an elastomeric respirator mask on cardiopulmonary, metabolic, and subjective parameters on healthcare workers. Methods: We conducted a controlled clinical trial on healthcare workers aged between 17-35 years old. Each subject performed a treadmill test (speed 5.6 km/hour) for 30 minutes while their physiological variables were monitored (pulse rate, respiratory rate, oxygen saturation, end-tidal CO2, body temperature, Borg scale, talk test, blood lactate, intermittent blood sugar, and subjective indicators). Each healthcare workers will be tested for four treatments, namely without using a mask, surgical mask, N95 mask, and elastomeric respirator. Results: All healthcare workers (age 25.10 ± 2.2 years old; 5 males and 5 females) completed the protocol with no adverse event. Pair-wise comparison using two-way ANOVA reported no significant difference within the mask condition for pulse rate (p=0.6497), respiratory rate (p=0.6772), oxygen saturation, (p=0.2587), end-tidal CO2 (p=0.0191), body temperature (p=0.7425), Borg scale (p=0.0930), blood lactate (p=0.6537) and glucose (p=0.8755). A statistically significant difference was reported in talk test (p=0.0129) with elastomeric respirator group showing highest result compared to control. Similarly, statistical significance was reported in subjective indicator of tightness (p=0.0017) with highest mean rank seen in N95 mask condition. However, these differences were clinically insignificant. Conclusions: The effect of surgical mask, N95 mask, and elastomeric respirator on the cardiopulmonary parameters, metabolic parameters, and subjective indicators during 30 minutes of low-moderate intensity exercise is negligible and generally well tolerated by healthcare workers. Registration: TCTR20230630001" } { "@context": "http://schema.org", "@type": "BreadcrumbList", "itemListElement": [ { "@type": "ListItem", "position": "1", "item": { "@id": "https://f1000research.com/", "name": "Home" } }, { "@type": "ListItem", "position": "2", "item": { "@id": "https://f1000research.com/browse/articles", "name": "Browse" } }, { "@type": "ListItem", "position": "3", "item": { "@id": "https://f1000research.com/articles/12-848", "name": "Effect of airway masks on physiological parameters of healthcare workers:..." } } ] } Home Browse Effect of airway masks on physiological parameters of healthcare workers:... ALL Metrics - Views Downloads Get PDF Get XML Cite How to cite this article Rahmad R, Nugroho MB, Ridwan M et al. Effect of airway masks on physiological parameters of healthcare workers: a clinical trial [version 1; peer review: 1 approved with reservations, 2 not approved] . F1000Research 2023, 12 :848 ( https://doi.org/10.12688/f1000research.130052.1 ) NOTE: If applicable, it is important to ensure the information in square brackets after the title is included in all citations of this article. Close Copy Citation Details Export Export Citation Sciwheel EndNote Ref. Manager Bibtex ProCite Sente EXPORT Select a format first Track Share ▬ ✚ Research Article Clinical trial Effect of airway masks on physiological parameters of healthcare workers: a clinical trial [version 1; peer review: 1 approved with reservations, 2 not approved] Rahmad Rahmad 1 , Muhammad Barlian Nugroho 1 , Mochammad Ridwan 1 , [...] Shabrina Narasati https://orcid.org/0000-0003-2982-6941 1 , Cholid Tri Tjahjono 2 , Holipah Holipah 3 , Mohammad Saifur Rohman 2 Rahmad Rahmad 1 , Muhammad Barlian Nugroho 1 , [...] Mochammad Ridwan 1 , Shabrina Narasati https://orcid.org/0000-0003-2982-6941 1 , Cholid Tri Tjahjono 2 , Holipah Holipah 3 , Mohammad Saifur Rohman 2 PUBLISHED 19 Jul 2023 Author details Author details 1 Physical Medicine and Rehabilitation, Faculty of Medicine Universitas Brawijaya, Saiful Anwar General Hospital, Malang, Jawa Timur, Indonesia 2 Cardiology and Vascular Medicine, Faculty of Medicine Universitas Brawijaya, Saiful Anwar General Hospital, Malang, Jawa Timur, Indonesia 3 Public Health, Faculty of Medicine Universitas Brawijaya, Malang, Jawa Timur, Indonesia Rahmad Rahmad Roles: Conceptualization, Methodology, Writing – Review & Editing Muhammad Barlian Nugroho Roles: Data Curation, Investigation, Supervision Mochammad Ridwan Roles: Project Administration, Software, Supervision Shabrina Narasati Roles: Formal Analysis, Writing – Original Draft Preparation Cholid Tri Tjahjono Roles: Funding Acquisition, Methodology, Resources Holipah Holipah Roles: Validation, Visualization, Writing – Review & Editing Mohammad Saifur Rohman Roles: Writing – Original Draft Preparation, Writing – Review & Editing OPEN PEER REVIEW DETAILS REVIEWER STATUS Abstract Background: Airway masks helps protect the wearer’s respiratory environment. There are many types of airway masks which differ in materials and effectiveness. This study aims to evaluate the effect of a surgical mask, the N95 mask, and an elastomeric respirator mask on cardiopulmonary, metabolic, and subjective parameters on healthcare workers. Methods: We conducted a controlled clinical trial on healthcare workers aged between 17-35 years old. Each subject performed a treadmill test (speed 5.6 km/hour) for 30 minutes while their physiological variables were monitored (pulse rate, respiratory rate, oxygen saturation, end-tidal CO2, body temperature, Borg scale, talk test, blood lactate, intermittent blood sugar, and subjective indicators). Each healthcare workers will be tested for four treatments, namely without using a mask, surgical mask, N95 mask, and elastomeric respirator. Results: All healthcare workers (age 25.10 ± 2.2 years old; 5 males and 5 females) completed the protocol with no adverse event. Pair-wise comparison using two-way ANOVA reported no significant difference within the mask condition for pulse rate ( p =0.6497), respiratory rate ( p =0.6772) , oxygen saturation, ( p =0.2587) , end-tidal CO 2 ( p =0.0191) , body temperature ( p =0.7425), Borg scale ( p =0.0930) , blood lactate ( p =0.6537) and glucose ( p =0.8755). A statistically significant difference was reported in talk test ( p =0.0129) with elastomeric respirator group showing highest result compared to control. Similarly, statistical significance was reported in subjective indicator of tightness ( p =0.0017) with highest mean rank seen in N95 mask condition. However, these differences were clinically insignificant. Conclusions: The effect of surgical mask, N95 mask, and elastomeric respirator on the cardiopulmonary parameters, metabolic parameters, and subjective indicators during 30 minutes of low-moderate intensity exercise is negligible and generally well tolerated by healthcare workers. Registration: TCTR20230630001 READ ALL READ LESS Keywords personal protective equipment, filtering facepiece respirator, cardiopulmonary, metabolic, subjective sensation, healthcare workers Corresponding Author(s) Muhammad Barlian Nugroho ( [email protected] ) Close Corresponding author: Muhammad Barlian Nugroho Competing interests: No competing interests were disclosed. Grant information: The author(s) declared that no grants were involved in supporting this work. Copyright: © 2023 Rahmad R et al . This is an open access article distributed under the terms of the Creative Commons Attribution License , which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. How to cite: Rahmad R, Nugroho MB, Ridwan M et al. Effect of airway masks on physiological parameters of healthcare workers: a clinical trial [version 1; peer review: 1 approved with reservations, 2 not approved] . F1000Research 2023, 12 :848 ( https://doi.org/10.12688/f1000research.130052.1 ) First published: 19 Jul 2023, 12 :848 ( https://doi.org/10.12688/f1000research.130052.1 ) Latest published: 19 Jul 2023, 12 :848 ( https://doi.org/10.12688/f1000research.130052.1 ) Introduction Since the COVID-19 pandemic occurred in February 2020, the World Health Organization has recommended the use of face masks as one of the preventative measures to reduce COVID-19 transmission. Face masks help protect the wearer’s respiratory environment from droplets that contains the virus, thus reducing the virus’s transmission. Face masks come in several types, such as cloth masks, surgical masks, N95 masks, respirator masks, etc. These masks differ in materials and effectiveness on reducing viral transmission. Masks with more condensed layers have a more protective barrier, thus are more effective in preventing viral transmission. Several types of masks, e.g. the N95 and elastomeric respirator masks, are able to give protection toward airborne agents as well as droplets. 1 Although it can help reduce the spread of COVID-19, wearing a face mask for a relatively long period of time can be uncomfortable. Prolonged use of face masks has been associated with exertion, breathing difficulties, headaches, and even light-headedness. A previous study by Scheid et al. 2 showed that wearing mask for more than four hours triggers several subjective discomforts. 2 Furthermore, the study also reported that people with a history of troublesome headaches were more likely to also experience headaches while using a mask for a long period of time. 2 In addition, Ipek et al . 3 showed that the causes of dizziness and headache while using respirators were associated with respiratory alkalosis and hypercarbia. 3 Heart rate is expected to increase during physical exertion. Hence, perceived exertion and difficulty in breathing often felt by mask users suggests that it might stimulate an increase in heart rate. Discomfort from wearing a mask has also been associated with the increased facial skin temperature and humidity inside the mask. However, a previous study using thermal imagery and an infrared thermometer found that while wearing a filtering facepiece respirator (N95 mask), facial skin temperature increased in a manner that was not clinically significant. 2 , 4 Subjective thermal comfort measured using a visual analog numerical scale while using a respirator also revealed a statistically insignificant difference compared to control. 5 The increased discomfort caused by prolonged face mask use can potentially reduce the optimal working condition of healthcare workers. Moreover, that discomfort might ultimately cause non-compliance on wearing face mask. This will increase the spread of COVID-19 in healthcare workers and their environment. In this study, we aimed to evaluate the effect of a surgical mask, N95 mask, and elastomeric respirator on physiological variables including pulse rate, respiratory rate, oxygen saturation, end-tidal CO2, body temperature, Borg scale, talk test, blood lactate, intermittent blood sugar, and subjective indicators in healthcare workers. Everyday workload was reflected in this study by low intensity treadmill test (5.6 km/h). The result of this research can aid in the future regulations regarding mask use for the public. Methods Ethics, consent and registration This study received approval from Dr. Saiful Anwar Hospital’s Ethics Commission on July 28 th , 2020 (ethical approval number: 400/159/K.3/302/2020). Written and verbal informed consent were received from the participants prior to starting the procedures. This study was registered retrospectively to Thai Clinical Trials Registration (TCTR) because the authors initially did not consider that this study could not be categorized as a clinical trial. The trial identification number is TCTR20230630001 ( https://www.thaiclinicaltrials.org/show/TCTR20230630001 ). Study design We conducted a non-randomized trial in which every participant underwent the same treatment (no mask, surgical mask, N95 mask, and elastomeric mask). The study trial went accordingly, hence no changes were made to the study procedure and population. Although a cloth mask condition was originally included, this has been excluded from analysis as it is no longer recommended by the Ministry of Health. This study took place in Dr. Saiful Anwar Hospital’s Malang, Indonesia. Study population The study population includes healthcare workers aged between 17-35 years old without cardiopulmonary, neuromuscular, and musculoskeletal disorders, with a body mass index (BMI) between 18.5-24.99kg/m 2 , and who are willing to take part in a series of tests and are able to sign their informed consent. Pregnant participants were also excluded. The healthcare workers participated under their own personal willingness. Prior to the start of the study, authors had distributed the announcement of this research project as to recruit potential participants. The information was relayed through broadcast message and banners in front of the physical rehabilitation and medicine department in Dr. Saiful Anwar Hospital. Participants who did not complete the research protocol and had to terminate their involvement while performing the tests were categorized as dropouts. Dropouts were not included in our final analysis. The absolute indications for test termination were as follows: a) participant’s request, b) systolic pressure drops > 10 mmHg below systolic pressure at rest while standing with evidence of ischemia, or > 20 mmHg after a previous systolic increase, and c) technical problems with equipment. The relative indications for termination were as follow; a) severe chest pain, b) tightness, fatigue, leg cramps, or claudication, c) systolic blood pressure ≥ 230 mmHg, diastolic ≥ 115 mmHg, and d) evidence of arrhythmia. The minimum number of participants was calculated using Federer’s formula. Sampling was carried out using consecutive sampling. Participants who fit the study criteria were included as the study population. Data collection and outcome After receiving approval from Dr. Saiful Anwar Hospital’s Ethics Commission, this research was carried out. Prior to recruitment, all participants were screened by an author (medical doctor) for illnesses. The form for this screening is available in the extended data. 28 The study procedures were demonstrated to the healthcare workers after they passed the health screening. All 10 of the participants passed the health screening, so no one was excluded from the study. All participants provided written and verbal informed consent. For 30 minutes, each healthcare worker ran on a treadmill (Berwyn) at a low-moderate intensity (5.6 km/h). Four separate treatments were prepared for each healthcare worker. First, they carried out the exercise without a mask. Second, while wearing a surgical mask. Third, they wore an N95 or similar respirator. Lastly, the healthcare workers used a reusable elastomeric respirator. Each treatment was conducted 7-14 days apart ( Figure 1 ). To keep the healthcare workers from falling, the treadmill speed was progressively decreased to zero at the end of each workout. The patients were then instructed to cool down by walking until their pulse rate dropped below 100 beats per minute. All the participants were asked to bring athletic clothing and shoes to be worn during the study. Figure 1. Flow of the study. Timing of the parameters is shown in Figure 2 . Each test was conducted once by each participant. Pulse rate and oxygen saturation was measured using a Withleof® handheld pulse oximeter. Capnography was used to measure respiratory rate and end-tidal CO 2 . Meanwhile, body temperature was measured using an infrared thermometer (Omron). Borg rating of perceived exertion (Borg Scale) was used to measure the physical sensations experienced by the healthcare workers. 6 The scale starts from 6 indicating no exertion at all to 20 indicating maximal exertion. These measurements were obtained before exercise, 3 minutes, 10 minutes, 20 minutes, and 30 minutes into the exercise, and then 3 minutes and 30 minutes after resting ( Figure 2 ). A talk test was conducted according to previous studies. 7 , 8 The healthcare workers joined in a conversation with the examiner, then the examiner determined how the subject talked. The range of talk test measurement is shown in Figure 3 . For the purpose of statistical analysis, the intensity of the exercise (light, moderate, and vigorous) was represented by 1, 2, and 3, respectively. If the participant could easily carry the conversation with the examiner, the physical activity then classified into light activity, etc. Blood lactate was measured by taking the participants’ capillary blood while running, using a blood lancet, which was then inserted to Accutrend® Plus Lactate. Blood glucose levels were also measured by taking the capillary blood and inserted to Accutrend® Plus Glucose. Figure 2. Timing of pulse rate, body temperature, and subjective sensations. Figure 3. Talk test measurement range. All participants were given a form that contains a subjective indicators scale. They were asked to rate each subjective indicator from 0 (not at all) to 10 (strongly) before exercise and then after they finished the exercise. The subjective indicators scale ( Figure 4 ) was adopted from a previous study by Li et al. 4 Figure 4. Subjective sensations scale. Statistical analysis A master table was used to record data that were gathered in this study. SPSS version 23.0 and GraphPad version 9.1.0 were used to analyze the data. The Saphiro-Wilk test was used to determine the normality of numerical data, after which homogeneous or normally distributed data ( p > 0.05) were presented with mean and standard deviation (SD), while data that were not normally distributed ( p > 0.05) were presented with the median (minimum value; maximum value). Pairwise comparison using the two-way ANOVA non-parametric test was used to examine the relationship between variables with non-homogeneous results. A statistically significant correlation is shown by a p-value of less than 0.05 (95% significance). If a significant value was obtained, a post-hoc multiple comparison analysis was performed with Dunn’s test. The relationship between the ordinal data was analyzed using a non-parametric pairwise comparative with Friedman’s two-way ANOVA test. A p-value below 0.05 indicates a statistically significant correlation (95% significance). If a significant value was obtained, a post hoc pair-wise comparison analysis was performed with Bonferroni’s correction. Results Healthcare workers characteristics A total of 10 healthcare workers (consisting of 5 men and 5 women) were recruited in this study. 27 All healthcare workers passed the health screening and completed the whole study protocol. The baseline characteristics assessed were gender, age, weight, height, and body mass index. As reported in Table 1 , the age range of study healthcare workers was 22-29 years with a mean of 25.10 years old, a mean body weight of 55.90±11.32 kg, height 162.8±8.2 cm, and BMI 20.97±3.0 kg/m 2 . No statistical difference was reported on these baseline characteristics ( Table 2 ). Table 1. Healthcare workers’ characteristics. Healthcare Workers Sex Age (years) Weight (kg) Height (cm) BMI (kg/m 2 ) A Male 25 58 160 22.7 B Male 25 77 172 26.0 C Male 29 42 164 15.6 D Female 29 65 165 23.9 E Female 24 53 155 22,1 F Female 25 45 148 20,5 G Female 22 45 160 17,6 H Female 23 48 158 19,2 I Male 25 60 173 20 J Male 24 66 173 22,1 Table 2. Baseline characteristics. Characteristics Mean ± SD p-value Age (years) 25.10 ± 2.2 0.064 Weight (kg) 55.90 ± 11.32 0.571 Height (cm) 162.8 ± 8.2 0.506 BMI (kg/m 2 ) 20.97 ± 3.0 0.995 Cardiovascular, respiratory and metabolic parameters The results of the normality test of all cardiorespiratory parameters, metabolic parameters, and subjective indicators were non-homogenous, hence they are reported in median, minimum and maximum. Table 3 compares the result of pulse rate, respiratory rate, oxygen saturation, end-tidal CO 2 , body temperature, Borg scale, talk test, blood lactate, and intermittent blood glucose in control, surgical mask, N95 mask, and elastomeric respirator group. Statistical analysis yielded insignificant differences between control, surgical mask, N95 mask, and elastomeric respirator group. Table 3. Cardiovascular, respiratory and metabolic parameters during exercise and after resting in control, surgical mask, N95 mask, and elastomeric respirator group. Trial/Time 0 min 3 min 10 min 15 min 20 min 30 min 3 min rest 30 min rest Cardiovascular Parameters Pulse rate (bpm) Control 87 (77;112) 107.5 (82;128) 135 (102;174) - 136 (109;170) 140 (108;167) 118.5 (86;140) 100 (79;123) Surgical mask 84 (66;112) 107 (97;120) 129.5 (119;150) - 129 (107;161) 148.5 (124;159) 125 (106;138) 95.5 (76;105) N95 mask 90 (76;117) 101.5 (77;130) 130 (115;157) - 145.5 (125;170) 140.5 (115;170) 118.5 (87;141) 97.5 (85;117) Elastomeric 97.5 (74;113) 125.5 (100;129) 129 (123;160) - 140 (108;167) 143.5 (115;170) 123 (107;150) 101 (85;123) Respiratory rate (breaths/min) Control 16 (12;20) 21 (12;30) 26.5 (13;33) - 27.5 (18;44) 26 (18;40) 20.5 (12;33) 16 (12;27) Surgical mask 15.5 (12;23) 22.5 (12;30) 23 (14;34) - 28 (13;36) 30.5 (15;33) 27 (13;32) 16.5 (11;20) N95 mask 17.5 (12;24) 23.5 (13;30) 30.5 (14;39) - 30.5 (14;35) 29 (13;39) 27 (17;37) 19.5 (12;24) Elastomeric 16.5 (12;26) 26 (12;37) 34.25 (15;40) - 28.5 (15;39) 30.5 (16;39) 27 (16;39) 15.5 (11;27) Oxygen saturation (%) Control 98 (98;99) 98 (96;99) 96.5 (94;99) - 98 (96;99) 97 (96;98) 97 (97;98) 97.5 (96;99) Surgical mask 97.5 (96;99) 98 (96;99) 97 (96;99) - 97 (96;98) 97.5 (95;99) 98 (96;99) 98 (97;99) N95 mask 98 (97;99) 98 (97;99) 98 (97;99) - 98 (96;98) 98 (96;98) 98 (97;99) 98 (97;99) Elastomeric 98 (96;99) 98 (87;99) 97.5 (96;98) - 98 (96;99) 98 (96;98) 98 (97;99) 98 (97;99) End-tidal CO 2 (%) Control 34 (29;38) 38 (35;50) 40 (32;46) - 37.5 (29;48) 39 (27;49) 35.5 (26;40) 31.5 (27;39) Surgical mask 36.5 (20;55) 43.5 (36;53) 43.5 (37;53) - 43 (36;51) 42.5 (34;50) 37 (27;44) 33.5 (27;47) N95 mask 36.5 (23;44) 42 (38;52) 42 (37;50) - 43 (37;51) 43 (36;52) 40.5 (32;45) 36.5 (33;43) Elastomeric 42 (33;46) * 45 (35;57) * 44 (38;55) - 47 (35;53) 43.5 (36;52) 40.5 (31;48) 39 (30;44) * Body temperature (°C) Control 36.4 (36.3;36.9) 36.4 (36.2;36.9) 36.4 (36.1;36.8) - 36.3 (36.1;36.7) 36.35 (36;36.6) 36.3 (35.5;36.8) 36.4 (36;36.7) Surgical mask 36.4 (36.1;37) 36.4 (36.1;36.9) 36.3 (36;36.6) - 36.2 (36;36.5) 36.25 (36;36.5) 36.3 (36;36.5) 36.4 (36.2;36.6) N95 mask 36.4 (36.2;36.9) 36.3 (36.2;36.7) 36.2 (36;36.4) - 36.2 (36;36.6) 36.4 (36;36.6) 36.3 (36.1;36.5) 36.4 (35.5;36.9) Elastomeric 36.3 (36.3;36.9) 36.3 (36.1;36.7) 36.2 (36;36.4) - 36.25 (36;36.6) 36.15 (36;36.5) 36.1 (36.1;36.5) 36.35 (36.2;36.6) Borg Scale Control 6 (6;7) 7 (6;12) 12 (6;14) - 14 (8;15) 15 (8;15) 9 (6;14) 6 (6;7) Surgical mask 6 (6;8) 6 (6;9) 9 (7;13) - 12 (8;13) 11.5 (8;15) 7.5 (6;11) 6 (6;8) N95 mask 6 (6;8) 6.5 (6;11) 8.5 (7;13) - 11 (8;15) 11.5 (9;15) 8.5 (6;12) 6 (6;7) Elastomeric 6 (6;11) 6.5 (6;11) 8 (7;13) - 10 (8;14) 11 (10;14) 8 (6;12) 6 (6;9) Talk test Control 1 (1;1) 1 (1;1) 1 (1;2) - - 2 (1;2) 2 (1;2) 1 (1;1) Surgical mask 1 (1;1) 1 (1;1) 1 (1;1) - - 1 (1;2) 1 (1;2) 1 (1;1) N95 mask 1 (1;1) 1 (1;1) 1 (1;2) - - 1 (1;2) 1 (1;2) 1 (1;1) Elastomeric 1 (1;1) 1 (1;1) 1 (1;1) - - 1 (1;2) 1 (1;2) † 1 (1;1) Metabolic Parameters Blood lactate (mmol/L) Control 1.65 (0.9;2.7) - - 4.2 (1.6; 10.4) 4.2 (1.6;10.4) - - 4 (1.9;10.6) Surgical mask 2.3 (1.7;4.6) - - 3.7 (1.2;4.9) 3.7 (1.2;4.9) - - 3.45 (2.1;6.2) N95 mask 2.25 (1;3.1) - - 4.15 (1,4;6,1) 4.15 (1.4;6.1) - - 3.05 (1.8;5.8) Elastomeric 2.25 (1.3;5.1) - - 4.25 (1.8;6.9) 4.25 (1.8;6.9) - - 3.4 (2.2;5.8) Blood glucose (mg/dL) Control 86 (76;148) - - - - - 94 (66;112) - Surgical mask 91 (74;133) - - - - - 85.5 (44;97) - N95 mask 91.5 (64;143) - - - - - 89 (62;108) - Elastomeric 98 (71;125) - - - - - 83 (73;98) - * statistically significant in main effect comparison ( p-value <0.05) . There was no statistically significant difference between all groups in every time for the median of pulse rate, respiratory rate, oxygen saturation, end-tidal CO 2 , body temperature, and Borg scale ( Table 3 ). Pair-wise comparison using two-way ANOVA ( Table 4 ) also reported no significant difference when analyzed within the mask condition for pulse rate ( p =0.6497), respiratory rate ( p =0.6772), oxygen saturation, ( p =0.2587), end-tidal CO 2 (p= 0.0191), body temperature (p= 0.7425), and Borg scale (p= 0.0930). Compared to the control condition, the elastomeric respirator condition had significant differences at 0-minutes (p= 0.0045), 3-minutes during exercise (p= 0.0353), and 30-minutes after rest (p=0.0243). A statistically significant effect of time ( Table 4 ) was reported for pulse rate (p=< 0.0001), respiratory rate (p=< 0.0001), oxygen saturation, (p= 0.0052), end-tidal CO 2 (p=< 0.0001), body temperature (p=< 0.0001), and Borg scale (p=< 0.0001). Table 4. Pair wise comparison (two-way ANOVA) on cardiorespiratory and metabolic parameters. Physiological parameters P values Time Mask Time x Mask Pulse rate <0.0001 * 0.6497 0.6094 Respiratory rate <0.0001 * 0.6772 0.6063 Oxygen saturation 0.0052 * 0.2587 0.5645 End-tidal CO 2 <0.0001 * 0.0191 0.8830 Body temperature <0.0001 * 0.7425 0.6838 Borg scale <0.0001 * 0.0930 0.0072 * Talk test <0.0001 * 0.0129 * 0.0006 * Lactate <0.0001 * 0.6537 0.0648 Glucose 0.0063 * 0.8755 0.9957 * statistically significant in main effect comparison ( p-value <0.05) . Results of the talk test revealed a statistically significant difference between control and elastomeric respirator ( p =0.0110). Between each time interval, a statistically significant difference compared to control was reported at minute-30 in elastomeric respirator group ( p =0.034). Analysis of blood lactate and glucose data resulted in no significant statistical difference when compared between mask conditions with p -value of 0.6537 and 0.8755 respectively. As seen in Table 3 , blood lactate levels on every group tend to increase during exercise and decrease while resting. Subjective indicators Table 5 describes the result of subjective indicators in surgical mask, N95 mask, and elastomeric respirator group. Pair wise comparison (two-way ANOVA) was reported in Table 6 . All subjective indicators’ variables excluding salty and unfit sensations have a statistically significant difference on time effects. Meanwhile, for mask effects, statistical difference was only reported in tight sensation with p -value of 0.0017. Analysis of the mean rank between mask conditions showed that the N95 condition most commonly scores higher in the tight sensation compared to the other mask conditions. Table 5. Subjective indicators for surgical mask, N95 mask, and elastomeric respirator group. Subjective sensations Humid Hot Breath resistance Itchy Tight * Salty Unfit Odor Fatigue Overall discomfort Surgical mask Before 0 (0;3) 1.25 (0;4) 0 (0;2) 0 (0;0) 0 (0;3) 0 (0;0) 0 (0;1) 0 (0;2) 0 (0;3) 0 (0;2) After 4.5 (0;6) 4 (0;6) 2 (0;8) 0 (0;0) 0 (0;5) 0 (0;0) 0 (0;1) 0 (0;5) 1.5 (0;5) 2.75 (0;5) N95 mask Before 1.5 (0;5) 1 (0;5) 0 (0;5) 0 (0;0) 3 (1;5) 0 (0;0.5) 0 (0;2) 0 (0;4.5) 0 (0;4) 1 (0;2) After 4 (1;8.5) 4.5 (1;6.5) 3.5 (0;8.5) 0 (0;4.5) 4.5 (1;8.5) 0 (0;1) 0 (0;4) 0 (0;5) 3 (0;10) 3 (0;5) Elastomeric Before 0 (0;3) 0 (0;3) 0 (0;4) 0 (0;1) 1.5 (0;8) 0 (0;1) 0 (0;2) 0 (0;3) 0 (0;3) 1 (0;5) After 3 (0;8) 4 (0;6) 0.5 (0;9) 0 (0;3) 2.5 (0;8) 0 (0;3) 0 (0;3) 0 (0;5) 4 (0;8) 25 (0;7) * statistically significant in main effect comparison ( p-value <0.05) . Table 6. Pair wise comparison (two-way ANOVA) on subjective sensation. Subjective sensation P values Time Mask Time x Mask Humid <0.0001 * 0.3768 0.4851 Hot <0.0001 * 0.2506 0.3891 Breath resistance <0.0001 * 0.5066 0.7144 Itchy 0.0187 * 0.1483 0.1809 Tight 0.0010 * 0.0017 * 0.5764 Salty 0.1286 0.1205 0.2624 Unfit 0.1073 0.5206 0.4462 Odor 0.0159 * 0.9719 0.2480 Fatigue <0.0001 * 0.2222 0.2998 * statistically significant in main effect comparison ( p-value <0.05) . Discussion The increased need for oxygen during physical exercise affects heart rate, which is reflected by the pulse rate in this study. Increased sympathetic response during physical exercise causes an increase in pulse rate. 9 This is shown in this study by the result of time effect in pair-wise comparison which means with each time period, the value of pulse rate differs. However, the difference between pulse rate between control and tested mask conditions did not show any statistically significant difference, which was in accordance with the results of several previous studies. 5 , 10 – 13 Contrary to our findings, there were several studies that showed significant differences in the use of filtering facepiece respirators, where the N95 mask condition showed a statistically significant difference in pulse rate compared to surgical mask condition. However, in that study, the treadmill speed tested was higher compared to this study, which was at 6.4km/h. The higher treadmill speed might have caused the significant difference seen between the two masks. 4 The increase of oxygen demand also affects the respiratory physiology. The physiological impact that occurs while using a mask is hypothesized to be caused by the filter media inside, which blocks the flow of air into the respiratory tract. 14 Thus, the more layers a mask has, the higher the resistance it will cause while breathing. Therefore, the respiratory rate is expected to increase as well. In this study, there was no significant difference between the various tested masks compared with controls. In this study, treadmill exercise did not cause the healthcare workers to reach a hypoxic state, with the lowest SpO 2 median of 96%. Previous studies have shown that physical exercise causes SpO 2 to decrease as oxygen demand increases. 15 Coupled with the possibility of an increase in respiratory resistance caused by wearing masks, the SpO 2 is expected to decrease in the tested mask conditions compared to the control conditoin. However, in this study, the SpO 2 values were not significantly different statistically compared to the control condition. The reason behind this might be due to the intensity of exercise carried out in this study (moderate intensity) did not cause an increase in oxygen demand that will significantly reduces SpO 2 . The other parameter of respiratory physiology are end-tidal CO 2 , capillary oxygen saturation, and the Borg scale. When PtcCO 2 value increases, the body will compensate by increasing the respiratory rate. 16 , 17 In this study, there was no statistically significant difference between the tested mask conditions and the control condition during physical exercise. This result is in accordance with previous studies. 10 , 11 , 13 , 18 Body temperature is very tightly regulated by thermoreceptors located in the hypothalamus. Physical exercise can trigger vasodilation which causes blood vessels to dilate to allow greater blood flow to the skin and ultimately increases skin temperature. 19 In this study, body temperature was described by skin temperature measured using an infrared thermometer placed on the forehead. The moderate intensity exercise in this study was not expected to trigger heat stress which stimulates an increase in skin temperature. This is consistent with the results of this study which showed that until the 30 th minute, the control condition did not show an increase in body temperature greater than 37.5 °C. Similar result can be seen in the tested mask conditions, where in the post-hoc analysis there was no significant difference compared with control, which means that the use of masks does not cause heat-stress in moderate-intensity physical exercise. Previous study by Kim et al. obtained similar results where the measurement of rectal temperature ( p = 0.519) and overall temperature ( p = 0.654) were similar in the FFR (filtering facepiece respirator) mask group and the control condition. 20 In the study by Li et al. comparing the skin temperature in the use of N95 masks with surgical masks, there was a significant difference where the skin temperature in the surgical mask group was lower than that of the N95 mask. 4 However, in that study the mask was used for longer period of time, namely for 100 minutes, and at a higher treadmill speed at 6.4km/h. This result showed that the FFR mask has the potential to cause greater metabolic stress when used for a longer period of time and at higher workload or exercise intensity. The scores for the Borg scale did not differ significantly between the control and the other tested masks. However, the median results of the Borg scale measurement increased with time, and decreased at rest, and this result was statistically significant. This shows that the value of the Borg scale, which describes exertion efforts, was influenced more by the length of time exercising than the use of mask. Several previous studies also found the similar result. A study by Roberge et al . compared Borg scale scores on a treadmill test using a filtering facepiece respirator at two different speeds (2.74 km/h vs. 4.03 km/h). The results of this study showed a significant difference in the scores for exertion ( p =0.01). 5 , 11 , 12 , 20 The concentration of serum lactate is a represent of anaerobic metabolism. 20 , 21 The results of this study indicated that lactate concentration increases after 15 minutes of exercise compared to the pre-exercise measurement even though when compared between the test mask groups, there was no significant difference. Thus, it can be concluded that the use of surgical, N95, or elastomeric respirator does not cause an increase or decrease in anaerobic metabolism compared to using no mask during the treadmill test. A study by Lassing et al. 23 showed that in exercise using constant load, the concentration of blood lactate in the control and surgical masks group was not significantly different ( p = 0.26). 23 The talk test has been used before in several studies to determine exercise intensity. 16 , 24 , 26 Exercise with moderate intensity will result in the ability of the healthcare workers to speak comfortably without gasping or the need to alter their speed. 25 Compared to control, there was a statistically different result in elastomeric respirator group ( Table 2 ). However, this difference was not clinically meaningful since in the mean of every group was in the range of light to moderate. The talk test has been proposed to be comparable with lactate threshold in measuring exercise intensity. 16 The findings in this study are in accordance with that, in which the value of blood lactate and talk test represented moderate exercise intensity in all group. This finding showed that using a mask did not increase exercise load, despite the presence of filtering layers. The cardiovascular system will respond to the exercise with an increase of cardiac output to deliver the oxygen and glucose to the muscles that play important roles in the metabolic process during physical exercise. 21 , 22 In this study, the results of the blood glucose measurements before exercise compared to 3 minutes after rest showed no significant difference. There are no studies yet that have examined the effects of using various masks on random blood glucose levels. This may be caused by the intensity of physical exercise. In addition, the duration of exercise was 30 minutes. This duration period might be too short for it to cause hypoglycemia. In addition, the ideal measurement of glucose consumption is to measure it directly on muscle cells i.e using nanobiosensor. 26 The results of the subjective indicators values before and after physical exercise showed no significant differences between the various masks, except for the tight sensation ( p = 0.0017) with the highest mean rank in the N95 mask group. A previous study by Li et al. 4 comparing the use of N95 masks and surgical masks showed significant differences in all subjective sensations with higher scores in the N95 mask group. 4 In this study, masks were tested for 100 minutes. Compared to other masks, the wearer of an N95 mask has the highest probability in feeling subjective discomforts. However, with a longer period of mask use, other types of masks also might also cause discomforts. Hence, studies with a longer period of mask use should be conducted in the future. Conclusions The effect of surgical masks, N95 masks, and elastomeric respirators on the cardiopulmonary and metabolic response during 30 minutes of low-moderate intensity exercise is negligible and generally well tolerated by healthy healthcare workers. Data availability Underlying data figshare: (Raw data) Effect of Airway Masks on Physiological Parameters of Healthcare Workers. https://doi.org/10.6084/m9.figshare.21981080.v2 . 27 This project contains the raw data file. Extended data figshare: (Appendix) Effect of Airway Masks on Physiological Parameters of Healthcare Workers. https://doi.org/10.6084/m9.figshare.21981029.v2 . 28 This project contains the consent form and other materials given to participants. Data are available under the terms of the Creative Commons Attribution 4.0 International license (CC-BY 4.0). Acknowledgments This article was presented in the 6 th International Conference and Exhibition on Indonesian Medical Education and Research Institute (6 th ICE on IMERI), Faculty of Medicine, Universitas Indonesia. We thank the 6 th ICE on IMERI committee, who had supported the peer-review and manuscript preparation before submitting it to the journal. We thank Yan Martha, Universitas Indonesia, for her assistance in editing and revising the final manuscript. References 1. Lepelletier D, Grandbastien B, Romano-Bertrand S, et al. : What face mask for what use in the context of the COVID-19 pandemic? the French guidelines. J. Hosp. Infect. 2020; 105 (3): 414–418. PubMed Abstract | Publisher Full Text | Free Full Text 2. Scheid JL, Lupien SP, Ford GS, et al. : Commentary: Physiological and psychological impact of face mask usage during the COVID-19 pandemic. Int. J. Environ. Res. Public Health. 2020; 17 (18): 1–12. 3. 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Obregón R, Ahadian S, Ramón-Azcón J, et al. : Non-invasive measurement of glucose uptake of skeletal muscle tissue models using a glucose nanobiosensor. Biosens. Bioelectron. 2013 Dec; 50 : 194–201. PubMed Abstract | Publisher Full Text 27. Narasati S: (Raw data) Effect of Airway Masks on Physiological Parameters of Healthcare Workers. Dataset. figshare. 2023. Publisher Full Text 28. Narasati S: (Appendix) Effect of Airway Masks on Physiological Parameters of Healthcare Workers. figshare. 2023. Online resource. Publisher Full Text Comments on this article Comments (0) Version 1 VERSION 1 PUBLISHED 19 Jul 2023 ADD YOUR COMMENT Comment Author details Author details 1 Physical Medicine and Rehabilitation, Faculty of Medicine Universitas Brawijaya, Saiful Anwar General Hospital, Malang, Jawa Timur, Indonesia 2 Cardiology and Vascular Medicine, Faculty of Medicine Universitas Brawijaya, Saiful Anwar General Hospital, Malang, Jawa Timur, Indonesia 3 Public Health, Faculty of Medicine Universitas Brawijaya, Malang, Jawa Timur, Indonesia Rahmad Rahmad Roles: Conceptualization, Methodology, Writing – Review & Editing Muhammad Barlian Nugroho Roles: Data Curation, Investigation, Supervision Mochammad Ridwan Roles: Project Administration, Software, Supervision Shabrina Narasati Roles: Formal Analysis, Writing – Original Draft Preparation Cholid Tri Tjahjono Roles: Funding Acquisition, Methodology, Resources Holipah Holipah Roles: Validation, Visualization, Writing – Review & Editing Mohammad Saifur Rohman Roles: Writing – Original Draft Preparation, Writing – Review & Editing Competing interests No competing interests were disclosed. Grant information The author(s) declared that no grants were involved in supporting this work. Article Versions (1) version 1 Published: 19 Jul 2023, 12:848 https://doi.org/10.12688/f1000research.130052.1 Copyright © 2023 Rahmad R et al . This is an open access article distributed under the terms of the Creative Commons Attribution License , which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. Download Export To Sciwheel Bibtex EndNote ProCite Ref. Manager (RIS) Sente metrics Views Downloads F1000Research - - PubMed Central info_outline Data from PMC are received and updated monthly. - - Citations open_in_new 0 open_in_new 0 open_in_new SEE MORE DETAILS CITE how to cite this article Rahmad R, Nugroho MB, Ridwan M et al. Effect of airway masks on physiological parameters of healthcare workers: a clinical trial [version 1; peer review: 1 approved with reservations, 2 not approved] . F1000Research 2023, 12 :848 ( https://doi.org/10.12688/f1000research.130052.1 ) NOTE: If applicable, it is important to ensure the information in square brackets after the title is included in all citations of this article. COPY CITATION DETAILS track receive updates on this article Track an article to receive email alerts on any updates to this article. TRACK THIS ARTICLE Share Open Peer Review Current Reviewer Status: ? Key to Reviewer Statuses VIEW HIDE Approved The paper is scientifically sound in its current form and only minor, if any, improvements are suggested Approved with reservations A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit. Not approved Fundamental flaws in the paper seriously undermine the findings and conclusions Version 1 VERSION 1 PUBLISHED 19 Jul 2023 Views 0 Cite How to cite this report: Burhan E. Reviewer Report For: Effect of airway masks on physiological parameters of healthcare workers: a clinical trial [version 1; peer review: 1 approved with reservations, 2 not approved] . F1000Research 2023, 12 :848 ( https://doi.org/10.5256/f1000research.142780.r189377 ) The direct URL for this report is: https://f1000research.com/articles/12-848/v1#referee-response-189377 NOTE: it is important to ensure the information in square brackets after the title is included in this citation. Close Copy Citation Details Reviewer Report 07 May 2025 Erlina Burhan , Department of Pulmonology and Respiratory Medicine, Faculty of Medicine, Universitas Indonesia - Dr. Cipto Mangunkusumo General Hospital, Jakarta, Indonesia Not Approved VIEWS 0 https://doi.org/10.5256/f1000research.142780.r189377 Summary of Manuscript This study evaluated the impact of wearing different types of airway masks—surgical, N95, and elastomeric respirators—on various physiological and subjective parameters in healthcare workers during moderate physical activity. Results showed no ... Continue reading READ ALL Summary of Manuscript This study evaluated the impact of wearing different types of airway masks—surgical, N95, and elastomeric respirators—on various physiological and subjective parameters in healthcare workers during moderate physical activity. Results showed no significant differences in most cardiopulmonary and metabolic indicators across mask conditions, except for minor but clinically insignificant changes in the talk test and subjective feeling of tightness. Overall, all mask types were well tolerated without adverse effects. Overall Assessment: This manuscript discusses an interesting topic regarding the impact of PPE use, specifically masks, on healthcare workers as assessed through basic physiological functions and laboratory parameters. The idea proposed by the authors is quite compelling; however, their failure to meet research standards (as the authors themselves claim this to be a clinical trial), adhere to research ethics, and ensure the validity of the data introduces bias and has the potential to cause serious academic errors. In this review, I will only highlight points that I consider major, as all minor errors in this manuscript stem from these major issues. Specific Comments: Research Ethics: The authors failed to meet ethical standards for human research, as the clinical trial was registered retrospectively after the study had already begun. This implies that, at the time of informed consent, participants were not made aware that the study was a clinical trial. Additionally, the trial registration was not conducted through the appropriate national registry of the country where the researchers and study site are based. To my knowledge, Indonesia already has an official registration system for clinical trials, either through the Ministry of Health or the National Agency of Drug and Food Control. Methodological Changes: At the beginning of the study, the authors mentioned an intervention that was initially included but later excluded due to recommendations from the Ministry of Health. However, the authors also stated that no procedural changes occurred. These two statements contradict each other and raise concerns about possible violations of participant rights. Sample Size: The authors stated that they used Federer’s formula to determine the minimum required sample size but did not justify their choice of formula. Based on this formula, the study should have included at least 16 subjects, yet only 10 were involved. This shortfall fails to meet the minimum sample size requirement, increasing the risk of bias and undermining the validity of the study’s findings. Sample Characteristics: In the methods section, the authors indicated that one of the inclusion criteria was a normal BMI (18.5–24.9), and that no subjects were excluded. However, the results showed that two participants had a BMI below the stated inclusion threshold. This discrepancy raises serious concerns about the validity and reliability of the data presented. Is the work clearly and accurately presented and does it cite the current literature? Yes Is the study design appropriate and is the work technically sound? No Are sufficient details of methods and analysis provided to allow replication by others? Partly If applicable, is the statistical analysis and its interpretation appropriate? Partly Are all the source data underlying the results available to ensure full reproducibility? No Are the conclusions drawn adequately supported by the results? No Competing Interests: No competing interests were disclosed. Reviewer Expertise: Respiratory disease, pulmonary infection, clinical trial I confirm that I have read this submission and believe that I have an appropriate level of expertise to state that I do not consider it to be of an acceptable scientific standard, for reasons outlined above. Close READ LESS CITE CITE HOW TO CITE THIS REPORT Burhan E. Reviewer Report For: Effect of airway masks on physiological parameters of healthcare workers: a clinical trial [version 1; peer review: 1 approved with reservations, 2 not approved] . F1000Research 2023, 12 :848 ( https://doi.org/10.5256/f1000research.142780.r189377 ) The direct URL for this report is: https://f1000research.com/articles/12-848/v1#referee-response-189377 NOTE: it is important to ensure the information in square brackets after the title is included in all citations of this article. COPY CITATION DETAILS Report a concern Respond or Comment COMMENT ON THIS REPORT Views 0 Cite How to cite this report: Deng Z. Reviewer Report For: Effect of airway masks on physiological parameters of healthcare workers: a clinical trial [version 1; peer review: 1 approved with reservations, 2 not approved] . F1000Research 2023, 12 :848 ( https://doi.org/10.5256/f1000research.142780.r246273 ) The direct URL for this report is: https://f1000research.com/articles/12-848/v1#referee-response-246273 NOTE: it is important to ensure the information in square brackets after the title is included in this citation. Close Copy Citation Details Reviewer Report 23 Feb 2024 Zhipeng Deng , Syracuse University, Syracuse, New York, USA Not Approved VIEWS 0 https://doi.org/10.5256/f1000research.142780.r246273 Regarding the literature review, it seems to overlook several relevant studies. Please consider including additional research on the concentrations of O2 and CO2 inside the face mask. How to determine the fit of wearing a mask? ... Continue reading READ ALL Regarding the literature review, it seems to overlook several relevant studies. Please consider including additional research on the concentrations of O2 and CO2 inside the face mask. How to determine the fit of wearing a mask? It is best to provide photos of the experiment, including masks, test procedures, measuring instruments and equipment Even though the author mentioned age range 17-35 in Abstract, the actual age range was 22-29. Could you share the reasoning or references behind choosing a low-intensity treadmill test at 5.6 km/h? More specifics about the testing conditions are needed, such as room temperature, the attire of participants, and the external temperature and season during the tests. Were participants required to follow any specific dietary or lifestyle restrictions, such as avoiding smoking or caffeine, before the test? Figure 3 contains too little information and is unnecessary. The choice of only 10 participants, with a narrow age range, raises questions about the study's breadth. Can you justify how this sample size was deemed adequate for the conclusions drawn? Especially conclusions for cardiovascular, respiratory and metabolic parameters. What is the sample size for similar studies? The scale used to measure subjective sensations seems overly simplistic. Consider incorporating established standard questionnaires that cover temperature, humidity, odor, fatigue, and comfort sensations more comprehensively. Incorporating figures to illustrate key findings might offer clearer insights than tables alone. In Discussion section the author mentioned and compared a lot of previous studies. Most state-of-the-art results should be mentioned in literature review in Introduction. Measuring instruments required more information, such as model and accuracy. Is the work clearly and accurately presented and does it cite the current literature? No Is the study design appropriate and is the work technically sound? Partly Are sufficient details of methods and analysis provided to allow replication by others? Partly If applicable, is the statistical analysis and its interpretation appropriate? Partly Are all the source data underlying the results available to ensure full reproducibility? Partly Are the conclusions drawn adequately supported by the results? Partly Competing Interests: No competing interests were disclosed. Reviewer Expertise: indoor airflow, IAQ, physiological signals I confirm that I have read this submission and believe that I have an appropriate level of expertise to state that I do not consider it to be of an acceptable scientific standard, for reasons outlined above. Close READ LESS CITE CITE HOW TO CITE THIS REPORT Deng Z. Reviewer Report For: Effect of airway masks on physiological parameters of healthcare workers: a clinical trial [version 1; peer review: 1 approved with reservations, 2 not approved] . F1000Research 2023, 12 :848 ( https://doi.org/10.5256/f1000research.142780.r246273 ) The direct URL for this report is: https://f1000research.com/articles/12-848/v1#referee-response-246273 NOTE: it is important to ensure the information in square brackets after the title is included in all citations of this article. COPY CITATION DETAILS Report a concern Respond or Comment COMMENT ON THIS REPORT Views 0 Cite How to cite this report: Choudhury A. Reviewer Report For: Effect of airway masks on physiological parameters of healthcare workers: a clinical trial [version 1; peer review: 1 approved with reservations, 2 not approved] . F1000Research 2023, 12 :848 ( https://doi.org/10.5256/f1000research.142780.r204105 ) The direct URL for this report is: https://f1000research.com/articles/12-848/v1#referee-response-204105 NOTE: it is important to ensure the information in square brackets after the title is included in this citation. Close Copy Citation Details Reviewer Report 19 Sep 2023 Arin Choudhury , Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi, Delhi, India Approved with Reservations VIEWS 0 https://doi.org/10.5256/f1000research.142780.r204105 I have reviewed the article you provided. It seems to be a detailed and comprehensive study on the effects of different types of masks (surgical mask, N95 mask, and elastomeric respirator) on healthcare workers during a low-moderate intensity exercise. Here ... Continue reading READ ALL I have reviewed the article you provided. It seems to be a detailed and comprehensive study on the effects of different types of masks (surgical mask, N95 mask, and elastomeric respirator) on healthcare workers during a low-moderate intensity exercise. Here are some observations: Strengths: Clear Objective: The study's objective, to evaluate the impact of various masks on physiological parameters in healthcare workers during exercise, is well-defined. Ethical Considerations: The study mentions receiving ethical approval and obtaining informed consent from participants, which is essential in research involving human subjects. Study Design: The non-randomized controlled trial design is suitable for this research question and is described in detail. Data Collection: The methods for collecting data, including the instruments used for measuring physiological parameters, are clearly explained. Statistical Analysis: The statistical methods used for data analysis are outlined, including the significance levels and post-hoc tests. Areas for Improvement: Introduction: While the introduction provides some context about the importance of masks during the COVID-19 pandemic, it could benefit from a more thorough review of existing literature related to mask usage during exercise and the associated discomforts. Methods: While the methods section is detailed, it might be beneficial to include information about the sample size calculation and the rationale behind the chosen treadmill speed and duration. Results: The results section provides a comprehensive overview of the findings, but it could benefit from visual aids such as tables or graphs to present numerical data and make it easier for readers to interpret the results. Additionally, some of the values mentioned in the text, such as p-values, should be included in tables or figures for clarity. Discussion: The discussion section is missing in the provided text. It's essential to include this section to interpret the results, compare them with previous research, discuss the implications of the findings, and highlight the limitations of the study. Plagiarism: Based on the text you've provided, there are no apparent signs of plagiarism. However, it's crucial to ensure that any information or text borrowed from other sources is properly cited when you complete the full article. Conclusion: The conclusion briefly summarizes the findings but does not provide a comprehensive interpretation or discussion of their significance. It should also highlight the practical implications for healthcare workers and future research directions. Overall, the article appears to be well-structured and provides valuable insights into the impact of different masks on healthcare workers during exercise. To enhance its quality, consider addressing the areas for improvement mentioned above and completing the discussion and conclusion sections when writing the full article. Is the work clearly and accurately presented and does it cite the current literature? Yes Is the study design appropriate and is the work technically sound? Yes Are sufficient details of methods and analysis provided to allow replication by others? Yes If applicable, is the statistical analysis and its interpretation appropriate? Yes Are all the source data underlying the results available to ensure full reproducibility? Yes Are the conclusions drawn adequately supported by the results? Yes Competing Interests: No competing interests were disclosed. Reviewer Expertise: Emergency and trauma, AI I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard, however I have significant reservations, as outlined above. Close READ LESS CITE CITE HOW TO CITE THIS REPORT Choudhury A. Reviewer Report For: Effect of airway masks on physiological parameters of healthcare workers: a clinical trial [version 1; peer review: 1 approved with reservations, 2 not approved] . F1000Research 2023, 12 :848 ( https://doi.org/10.5256/f1000research.142780.r204105 ) The direct URL for this report is: https://f1000research.com/articles/12-848/v1#referee-response-204105 NOTE: it is important to ensure the information in square brackets after the title is included in all citations of this article. COPY CITATION DETAILS Report a concern Respond or Comment COMMENT ON THIS REPORT Comments on this article Comments (0) Version 1 VERSION 1 PUBLISHED 19 Jul 2023 ADD YOUR COMMENT Comment keyboard_arrow_left keyboard_arrow_right Open Peer Review Reviewer Status info_outline Alongside their report, reviewers assign a status to the article: Approved The paper is scientifically sound in its current form and only minor, if any, improvements are suggested Approved with reservations A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit. Not approved Fundamental flaws in the paper seriously undermine the findings and conclusions Reviewer Reports Invited Reviewers 1 2 3 Version 1 19 Jul 23 read read read Arin Choudhury , Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi, India Zhipeng Deng , Syracuse University, Syracuse, USA Erlina Burhan , Universitas Indonesia - Dr. Cipto Mangunkusumo General Hospital, Jakarta, Indonesia Comments on this article All Comments (0) Add a comment Sign up for content alerts Sign Up You are now signed up to receive this alert Browse by related subjects keyboard_arrow_left Back to all reports Reviewer Report 0 Views copyright © 2025 Burhan E. This is an open access peer review report distributed under the terms of the Creative Commons Attribution License , which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. 07 May 2025 | for Version 1 Erlina Burhan , Department of Pulmonology and Respiratory Medicine, Faculty of Medicine, Universitas Indonesia - Dr. Cipto Mangunkusumo General Hospital, Jakarta, Indonesia 0 Views copyright © 2025 Burhan E. This is an open access peer review report distributed under the terms of the Creative Commons Attribution License , which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. format_quote Cite this report speaker_notes Responses (0) Not Approved info_outline Alongside their report, reviewers assign a status to the article: Approved The paper is scientifically sound in its current form and only minor, if any, improvements are suggested Approved with reservations A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit. Not approved Fundamental flaws in the paper seriously undermine the findings and conclusions Summary of Manuscript This study evaluated the impact of wearing different types of airway masks—surgical, N95, and elastomeric respirators—on various physiological and subjective parameters in healthcare workers during moderate physical activity. Results showed no significant differences in most cardiopulmonary and metabolic indicators across mask conditions, except for minor but clinically insignificant changes in the talk test and subjective feeling of tightness. Overall, all mask types were well tolerated without adverse effects. Overall Assessment: This manuscript discusses an interesting topic regarding the impact of PPE use, specifically masks, on healthcare workers as assessed through basic physiological functions and laboratory parameters. The idea proposed by the authors is quite compelling; however, their failure to meet research standards (as the authors themselves claim this to be a clinical trial), adhere to research ethics, and ensure the validity of the data introduces bias and has the potential to cause serious academic errors. In this review, I will only highlight points that I consider major, as all minor errors in this manuscript stem from these major issues. Specific Comments: Research Ethics: The authors failed to meet ethical standards for human research, as the clinical trial was registered retrospectively after the study had already begun. This implies that, at the time of informed consent, participants were not made aware that the study was a clinical trial. Additionally, the trial registration was not conducted through the appropriate national registry of the country where the researchers and study site are based. To my knowledge, Indonesia already has an official registration system for clinical trials, either through the Ministry of Health or the National Agency of Drug and Food Control. Methodological Changes: At the beginning of the study, the authors mentioned an intervention that was initially included but later excluded due to recommendations from the Ministry of Health. However, the authors also stated that no procedural changes occurred. These two statements contradict each other and raise concerns about possible violations of participant rights. Sample Size: The authors stated that they used Federer’s formula to determine the minimum required sample size but did not justify their choice of formula. Based on this formula, the study should have included at least 16 subjects, yet only 10 were involved. This shortfall fails to meet the minimum sample size requirement, increasing the risk of bias and undermining the validity of the study’s findings. Sample Characteristics: In the methods section, the authors indicated that one of the inclusion criteria was a normal BMI (18.5–24.9), and that no subjects were excluded. However, the results showed that two participants had a BMI below the stated inclusion threshold. This discrepancy raises serious concerns about the validity and reliability of the data presented. Is the work clearly and accurately presented and does it cite the current literature? Yes Is the study design appropriate and is the work technically sound? No Are sufficient details of methods and analysis provided to allow replication by others? Partly If applicable, is the statistical analysis and its interpretation appropriate? Partly Are all the source data underlying the results available to ensure full reproducibility? No Are the conclusions drawn adequately supported by the results? No Competing Interests No competing interests were disclosed. Reviewer Expertise Respiratory disease, pulmonary infection, clinical trial I confirm that I have read this submission and believe that I have an appropriate level of expertise to state that I do not consider it to be of an acceptable scientific standard, for reasons outlined above. reply Respond to this report Responses (0) Burhan E. Peer Review Report For: Effect of airway masks on physiological parameters of healthcare workers: a clinical trial [version 1; peer review: 1 approved with reservations, 2 not approved] . F1000Research 2023, 12 :848 ( https://doi.org/10.5256/f1000research.142780.r189377) NOTE: it is important to ensure the information in square brackets after the title is included in this citation. The direct URL for this report is: https://f1000research.com/articles/12-848/v1#referee-response-189377 keyboard_arrow_left Back to all reports Reviewer Report 0 Views copyright © 2024 Deng Z. This is an open access peer review report distributed under the terms of the Creative Commons Attribution License , which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. 23 Feb 2024 | for Version 1 Zhipeng Deng , Syracuse University, Syracuse, New York, USA 0 Views copyright © 2024 Deng Z. This is an open access peer review report distributed under the terms of the Creative Commons Attribution License , which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. format_quote Cite this report speaker_notes Responses (0) Not Approved info_outline Alongside their report, reviewers assign a status to the article: Approved The paper is scientifically sound in its current form and only minor, if any, improvements are suggested Approved with reservations A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit. Not approved Fundamental flaws in the paper seriously undermine the findings and conclusions Regarding the literature review, it seems to overlook several relevant studies. Please consider including additional research on the concentrations of O2 and CO2 inside the face mask. How to determine the fit of wearing a mask? It is best to provide photos of the experiment, including masks, test procedures, measuring instruments and equipment Even though the author mentioned age range 17-35 in Abstract, the actual age range was 22-29. Could you share the reasoning or references behind choosing a low-intensity treadmill test at 5.6 km/h? More specifics about the testing conditions are needed, such as room temperature, the attire of participants, and the external temperature and season during the tests. Were participants required to follow any specific dietary or lifestyle restrictions, such as avoiding smoking or caffeine, before the test? Figure 3 contains too little information and is unnecessary. The choice of only 10 participants, with a narrow age range, raises questions about the study's breadth. Can you justify how this sample size was deemed adequate for the conclusions drawn? Especially conclusions for cardiovascular, respiratory and metabolic parameters. What is the sample size for similar studies? The scale used to measure subjective sensations seems overly simplistic. Consider incorporating established standard questionnaires that cover temperature, humidity, odor, fatigue, and comfort sensations more comprehensively. Incorporating figures to illustrate key findings might offer clearer insights than tables alone. In Discussion section the author mentioned and compared a lot of previous studies. Most state-of-the-art results should be mentioned in literature review in Introduction. Measuring instruments required more information, such as model and accuracy. Is the work clearly and accurately presented and does it cite the current literature? No Is the study design appropriate and is the work technically sound? Partly Are sufficient details of methods and analysis provided to allow replication by others? Partly If applicable, is the statistical analysis and its interpretation appropriate? Partly Are all the source data underlying the results available to ensure full reproducibility? Partly Are the conclusions drawn adequately supported by the results? Partly Competing Interests No competing interests were disclosed. Reviewer Expertise indoor airflow, IAQ, physiological signals I confirm that I have read this submission and believe that I have an appropriate level of expertise to state that I do not consider it to be of an acceptable scientific standard, for reasons outlined above. reply Respond to this report Responses (0) Deng Z. Peer Review Report For: Effect of airway masks on physiological parameters of healthcare workers: a clinical trial [version 1; peer review: 1 approved with reservations, 2 not approved] . F1000Research 2023, 12 :848 ( https://doi.org/10.5256/f1000research.142780.r246273) NOTE: it is important to ensure the information in square brackets after the title is included in this citation. The direct URL for this report is: https://f1000research.com/articles/12-848/v1#referee-response-246273 keyboard_arrow_left Back to all reports Reviewer Report 0 Views copyright © 2023 Choudhury A. This is an open access peer review report distributed under the terms of the Creative Commons Attribution License , which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. 19 Sep 2023 | for Version 1 Arin Choudhury , Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi, Delhi, India 0 Views copyright © 2023 Choudhury A. This is an open access peer review report distributed under the terms of the Creative Commons Attribution License , which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. format_quote Cite this report speaker_notes Responses (0) Approved With Reservations info_outline Alongside their report, reviewers assign a status to the article: Approved The paper is scientifically sound in its current form and only minor, if any, improvements are suggested Approved with reservations A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit. Not approved Fundamental flaws in the paper seriously undermine the findings and conclusions I have reviewed the article you provided. It seems to be a detailed and comprehensive study on the effects of different types of masks (surgical mask, N95 mask, and elastomeric respirator) on healthcare workers during a low-moderate intensity exercise. Here are some observations: Strengths: Clear Objective: The study's objective, to evaluate the impact of various masks on physiological parameters in healthcare workers during exercise, is well-defined. Ethical Considerations: The study mentions receiving ethical approval and obtaining informed consent from participants, which is essential in research involving human subjects. Study Design: The non-randomized controlled trial design is suitable for this research question and is described in detail. Data Collection: The methods for collecting data, including the instruments used for measuring physiological parameters, are clearly explained. Statistical Analysis: The statistical methods used for data analysis are outlined, including the significance levels and post-hoc tests. Areas for Improvement: Introduction: While the introduction provides some context about the importance of masks during the COVID-19 pandemic, it could benefit from a more thorough review of existing literature related to mask usage during exercise and the associated discomforts. Methods: While the methods section is detailed, it might be beneficial to include information about the sample size calculation and the rationale behind the chosen treadmill speed and duration. Results: The results section provides a comprehensive overview of the findings, but it could benefit from visual aids such as tables or graphs to present numerical data and make it easier for readers to interpret the results. Additionally, some of the values mentioned in the text, such as p-values, should be included in tables or figures for clarity. Discussion: The discussion section is missing in the provided text. It's essential to include this section to interpret the results, compare them with previous research, discuss the implications of the findings, and highlight the limitations of the study. Plagiarism: Based on the text you've provided, there are no apparent signs of plagiarism. However, it's crucial to ensure that any information or text borrowed from other sources is properly cited when you complete the full article. Conclusion: The conclusion briefly summarizes the findings but does not provide a comprehensive interpretation or discussion of their significance. It should also highlight the practical implications for healthcare workers and future research directions. Overall, the article appears to be well-structured and provides valuable insights into the impact of different masks on healthcare workers during exercise. To enhance its quality, consider addressing the areas for improvement mentioned above and completing the discussion and conclusion sections when writing the full article. Is the work clearly and accurately presented and does it cite the current literature? Yes Is the study design appropriate and is the work technically sound? Yes Are sufficient details of methods and analysis provided to allow replication by others? Yes If applicable, is the statistical analysis and its interpretation appropriate? Yes Are all the source data underlying the results available to ensure full reproducibility? Yes Are the conclusions drawn adequately supported by the results? Yes Competing Interests No competing interests were disclosed. Reviewer Expertise Emergency and trauma, AI I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard, however I have significant reservations, as outlined above. reply Respond to this report Responses (0) Choudhury A. Peer Review Report For: Effect of airway masks on physiological parameters of healthcare workers: a clinical trial [version 1; peer review: 1 approved with reservations, 2 not approved] . F1000Research 2023, 12 :848 ( https://doi.org/10.5256/f1000research.142780.r204105) NOTE: it is important to ensure the information in square brackets after the title is included in this citation. The direct URL for this report is: https://f1000research.com/articles/12-848/v1#referee-response-204105 Alongside their report, reviewers assign a status to the article: Approved - the paper is scientifically sound in its current form and only minor, if any, improvements are suggested Approved with reservations - A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit. Not approved - fundamental flaws in the paper seriously undermine the findings and conclusions Adjust parameters to alter display View on desktop for interactive features Includes Interactive Elements View on desktop for interactive features Competing Interests Policy Provide sufficient details of any financial or non-financial competing interests to enable users to assess whether your comments might lead a reasonable person to question your impartiality. 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