ObesityNCT05950256
Physiological Impact of Surgical Mask and N95 Mask on Obese Operating Room
A study testing N95 mask and surgical mask in people with Obesity, run by Qilu Hospital of Shandong University at 1 site in China.
Trial summary
During the SARS CoV-2 pandemic, in order to reduce the risk of infection among healthcare workers, healthcare workers are usually required to wear N95 masks for extended periods of time in high-risk environments. Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- N95 mask and surgical mask
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 19 Jul 2023to 30 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Inclusion criteria： anesthesiologists or nurses working in the operating room, aged 20-60 years old, body mass index (BMI)>30kg/m2, clearly healthy, and without any history of chronic diseases.
Exclude criteria： recent acute or chronic respiratory disease, recent history of headache and dizziness, pregnancy or lactation, rhinitis, Nasal polyp or poor breathing, facial skin inflammation and skin laxity.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Physiological Impact of Surgical Mask and N95 Mask on Obese Operating Room Staff：A Randomized-Controlled Cross-Over Trial
During the SARS CoV-2 pandemic, in order to reduce the risk of infection among healthcare workers, healthcare workers are usually required to wear N95 masks for extended periods of time in high-risk environments. The long-term use of masks by medical staff has been proven to be related to various symptoms, including headaches, dizziness, facial skin disease symptoms, and other occupational disturbances . Our previous research found that among healthy anesthesiologists with normal weight, wearing a Surgical mask for more than 2h can significantly reduce peripheral blood oxygen saturation (SpO2) and increase respiratory rate (RR). Rebmann et al. investigated the physiological effects of N95 masks on healthcare workers, and the results showed a statistically significant increase in end-tidal CO2 pressure （PetCO2）among 10 intensive care unit nurses who used N95 masks on a 12 hour shift. Recently, it has been confirmed that prolonged use of N95 masks can cause changes in gas exchange, including a decrease in plasma pH and venous partial pressure of oxygen (PvO2), and a slight increase in PetCO2.
Obesity is defined as abnormal or excessive fat accumulation that poses a risk to health and can cause baseline lung function impairment and decreased immune function. According to the standards of the World Health Organization (WHO), people with a body mass index (BMI) greater than 30 kg/m2 are classified as obese. Research shows that obese patients are the population with the highest risk of SARS CoV-2 infection related incidence rate and mortality. Research has shown that healthcare workers who work long hours are more likely to become obese due to changes in body regulation, metabolism, and stress. Long term use of N95 masks by medical staff may lead to a certain degree of insufficient ventilation and/or CO2 re breathing. Obesity itself has a significant impact on the heart and lungs, but the potential physiological effects of long-term wearing of N95 masks on obese healthcare workers have not been studied. The purpose of our study is to determine the abnormal gas exchange and physiological changes of obese doctors and nurses in the operating room who wear Surgical mask and N95 mask for 4 hours.
Read the detailed description
We plan to recruit 20 non-smoking and healthy obese medical staff, regardless of gender, from the anesthesia doctors and nurses in the operating room, who sign written informed consent forms.
This is a prospective, randomized, cross controlled trial. Develop a sequence number for 20 participants in the order of enrollment. The participants were randomly assigned to the N95 mask group (n=10 cases) and the Surgical mask group (n=10 cases) using the random number method. Before the participants are grouped, group concealment is performed and the random grouping scheme is saved using a shaded envelope. Open the envelopes in the order of the participants joining the group, and determine the grouping situation based on the allocation plan inside the envelopes. The N95 respirator group and the Surgical mask group were used in the two stages of cross operation. When the first round of test was completed and after a 24-hour washing out period, the subjects in the Surgical mask group and the N95 respirator group were exchanged for the second round of test. The steps and methods were the same as those in the first stage.
During the study, each candidate must correctly wear a disposable bandage type medical Surgical mask or a disposable N95 mask. After wearing, it is necessary to check whether it is worn properly and whether there is air leakage. At the beginning of the test, participants are required to avoid using masks for at least 10 minutes, measure their right index finger in a sitting position, and collect baseline (T1) data under normal breathing, including SpO2, Pulse rate (PR), RR, PetCO2, blood pressure (BP). Collect 1ml of venous blood to measure the baseline venous blood gas value.
All subjective sensations were rated using a 10 point VAS digital scale for subjective sensations such as headache, dizziness, difficulty breathing, and facial discomfort. A score of 0 indicates no discomfort, while a score of 10 indicates the most severe imaginable discomfort. Then participants were asked to wear Surgical mask or N95 mask for 4 hours to start medical work. Subsequently, immediately after using masks (T2) and continuously wearing masks for 1 hour (T3), 2 hours (T4), 3 hours (T5), and 4 hours (T6), the above data was collected using the same method. In order to minimize data variability, data was collected twice at each time point and the average was taken. After continuous wear for 4 hours, 1ml of venous blood was taken for blood gas analysis.
If the subject is unable to persist, they can immediately remove the cover and abandon the experiment; Researchers monitored these subjects until symptoms improved. Second round test: After the first round of test is completed, the second round test is conducted after a 24-hour washing period. In the second round of test, the subjects of N95 mask group and Surgical mask group in the first round of test were exchanged, and the test was conducted according to the steps and data collection methods of the first round of test.
- Conditions
- Obesity
- Being tested
- N95 mask and surgical mask
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
N95 mask and surgical maskDevice
Twenty participants were randomly assigned to the N95 mask group (n=10 ) and the Surgical mask group (n=10 ). The N95 mask group and the Surgical mask group were used in two stages alternately. When the first round of the test was completed and after a 24-hour washing out period, the participants of the Surgical mask group and the N95 respirator group were exchanged for the second round of the test.
| Study group | Role | What they receive |
|---|---|---|
| N95 mask group | Experimental | Continuously wearing N95 mask for 4 hours Receives: Device: N95 mask and surgical mask |
| Surgical mask group | Active comparator | Continuously wearing surgical mask for 4 hours Receives: Device: N95 mask and surgical mask |
What is being measured
The primary outcome is the main question the study is designed to answer.
PvCO2
PvCO2 values in venous blood gas after wearing surgical masks or N95 masks for 4 hours
Measured: 4 hours
Secondary outcomes (10)
peripheral oxygen saturation (SpO2)
6 time points before, immediately, 1 hour (h), 2h, 3h and 4h after the continuous wearing of Surgical mask or N95 mask
Measured: 4 hours
pulse rate (PR)
6 time points before, immediately, 1h, 2h, 3h and 4h after the continuous wearing of Surgical mask or N95 mask
Measured: 4 hours
PetCO2
6 time points before, immediately, 1h, 2h, 3h and 4h after the continuous wearing of Surgical mask or N95 mask
Measured: 4 hours
Visual analog scale (VAS) scores
All sensations were scored by means of a 10-point VAS from 0 (no discomfort) to 10 (worst discomfort imaginable). To minimize variability, data were collected twice at each point in time. To score the subjective discomfort (including dizziness, headache, dyspnea and nasofacial discomfort).
Measured: 4 hours
PvCO2
PvCO2 in venous blood gas before wearing a mask
Measured: 0 hours
PvO2
PvO2 in venous blood before and after wearing a mask for 4 hours
Measured: 0 hours，4 hours
pH
pH in venous blood before and after wearing a mask for 4 hours
Measured: 0 hours，4 hours
HCO3-
HCO3- in venous blood before and after wearing a mask for 4 hours
Measured: 0 hours，4 hours
systolic pressure
systolic pressure
Measured: 6 time points before, immediately, 1h, 2h, 3h and 4h after the continuous wearing of Surgical mask or N95 mask
diastolic pressure
diastolic pressure
Measured: 6 time points before, immediately, 1h, 2h, 3h and 4h after the continuous wearing of Surgical mask or N95 mask
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2023
- Study start19 Jul 2023
- Primary completion30 Sep 2023
- Study completion30 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Qilu Hospital of Shandong UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Qilu Hospital of Shandong University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shaozhong Yang, Doctor, Study chair, Qilu Hospital of Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05950256
- Sponsor's protocol ID
- KYLL-202306-032
- Status last verified
- Jul 2023
- First submitted
- 10 Jul 2023
- Last updated
- 20 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: After the research is completed, share research data, research plans, statistical analysis plans, informed consent forms, and other data
Publications
Luo C, Yao L, Zhang L, Yao M, Chen X, Wang Q, Shen H. Possible Transmission of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) in a Public Bath Center in Huai'an, Jiangsu Province, China. JAMA Netw Open. 2020 Mar 2;3(3):e204583. doi: 10.1001/jamanetworkopen.2020.4583.
PubMed 32227177O'Hara LM, Thom KA, Preas MA. Update to the Centers for Disease Control and Prevention and the Healthcare Infection Control Practices Advisory Committee Guideline for the Prevention of Surgical Site Infection (2017): A summary, review, and strategies for implementation. Am J Infect Control. 2018 Jun;46(6):602-609. doi: 10.1016/j.ajic.2018.01.018. Epub 2018 Mar 7.
PubMed 29525367Scheid JL, Lupien SP, Ford GS, West SL. Commentary: Physiological and Psychological Impact of Face Mask Usage during the COVID-19 Pandemic. Int J Environ Res Public Health. 2020 Sep 12;17(18):6655. doi: 10.3390/ijerph17186655.
PubMed 32932652Yang S, Fang C, Liu X, Liu Y, Huang S, Wang R, Qi F. Surgical Masks Affect the Peripheral Oxygen Saturation and Respiratory Rate of Anesthesiologists. Front Med (Lausanne). 2022 Apr 14;9:844710. doi: 10.3389/fmed.2022.844710. eCollection 2022.
PubMed 35492371Rebmann T, Carrico R, Wang J. Physiologic and other effects and compliance with long-term respirator use among medical intensive care unit nurses. Am J Infect Control. 2013 Dec;41(12):1218-23. doi: 10.1016/j.ajic.2013.02.017. Epub 2013 Jun 12.
PubMed 23768438Shechtman L, Ben-Haim G, Ben-Zvi I, Steel L, Ironi A, Huszti E, Chatterji S, Levy L. Physiological Effects of Wearing N95 Respirator on Medical Staff During Prolong Work Hours in Covid-19 Departments. J Occup Environ Med. 2022 Jun 1;64(6):e378-e380. doi: 10.1097/JOM.0000000000002542. Epub 2022 May 4.
PubMed 35543650Zhou Y, Chi J, Lv W, Wang Y. Obesity and diabetes as high-risk factors for severe coronavirus disease 2019 (Covid-19). Diabetes Metab Res Rev. 2021 Feb;37(2):e3377. doi: 10.1002/dmrr.3377. Epub 2020 Jul 20.
PubMed 32588943Luckhaupt SE, Cohen MA, Li J, Calvert GM. Prevalence of obesity among U.S. workers and associations with occupational factors. Am J Prev Med. 2014 Mar;46(3):237-48. doi: 10.1016/j.amepre.2013.11.002.
PubMed 24512862Sharma SV, Upadhyaya M, Karhade M, Baun WB, Perkison WB, Pompeii LA, Brown HS, Hoelscher DM. Are Hospital Workers Healthy?: A Study of Cardiometabolic, Behavioral, and Psychosocial Factors Associated With Obesity Among Hospital Workers. J Occup Environ Med. 2016 Dec;58(12):1231-1238. doi: 10.1097/JOM.0000000000000895.
PubMed 27930484Dixon AE, Peters U. The effect of obesity on lung function. Expert Rev Respir Med. 2018 Sep;12(9):755-767. doi: 10.1080/17476348.2018.1506331. Epub 2018 Aug 14.
PubMed 30056777Fang C, Ba Y, Gao Y, Liu Y, Yang S. Physiological impact of surgical masks and N95 masks on obese operating room staff. Sci Rep. 2025 Feb 24;15(1):6533. doi: 10.1038/s41598-025-91578-9.
PubMed 39994350
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physiological Impact of Surgical Mask and N95 Mask on Obese Operating Room Staff：A Randomized-Controlled Cross-Over Trial
- ClinicalTrials.gov ID
- NCT05950256
- Acronym / sponsor ID
- KYLL-202306-032
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Qilu Hospital of Shandong UniversityUniversity, hospital or other
- Study start
- 19 Jul 2023 (actual)
- Primary completion
- 30 Sep 2023 (actual)
- Study completion
- 30 Jan 2024 (actual)
- First posted
- 18 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
During the SARS CoV-2 pandemic, in order to reduce the risk of infection among healthcare workers, healthcare workers are usually required to wear N95 masks for extended periods of time in high-risk environments. The long-term use of masks by medical staff has been proven to be related to various symptoms, including headaches, dizziness, facial skin disease symptoms, and other occupational disturbances . Our previous research found that among healthy anesthesiologists with normal weight, wearing a Surgical mask for more than 2h can significantly reduce peripheral blood oxygen saturation (SpO2) and increase respiratory rate (RR). Rebmann et al. investigated the physiological effects of N95 masks on healthcare workers, and the results showed a statistically significant increase in end-tidal CO2 pressure （PetCO2）among 10 intensive care unit nurses who used N95 masks on a 12 hour shift. Recently, it has been confirmed that prolonged use of N95 masks can cause changes in gas exchange, including a decrease in plasma pH and venous partial pressure of oxygen (PvO2), and a slight increase in PetCO2.
Obesity is defined as abnormal or excessive fat accumulation that poses a risk to health and can cause baseline lung function impairment and decreased immune function. According to the standards of the World Health Organization (WHO), people with a body mass index (BMI) greater than 30 kg/m2 are classified as obese. Research shows that obese patients are the population with the highest risk of SARS CoV-2 infection related incidence rate and mortality. Research has shown that healthcare workers who work long hours are more likely to become obese due to changes in body regulation, metabolism, and stress. Long term use of N95 masks by medical staff may lead to a certain degree of insufficient ventilation and/or CO2 re breathing. Obesity itself has a significant impact on the heart and lungs, but the potential physiological effects of long-term wearing of N95 masks on obese healthcare workers have not been studied. The purpose of our study is to determine the abnormal gas exchange and physiological changes of obese doctors and nurses in the operating room who wear Surgical mask and N95 mask for 4 hours.
Detailed description
We plan to recruit 20 non-smoking and healthy obese medical staff, regardless of gender, from the anesthesia doctors and nurses in the operating room, who sign written informed consent forms.
This is a prospective, randomized, cross controlled trial. Develop a sequence number for 20 participants in the order of enrollment. The participants were randomly assigned to the N95 mask group (n=10 cases) and the Surgical mask group (n=10 cases) using the random number method. Before the participants are grouped, group concealment is performed and the random grouping scheme is saved using a shaded envelope. Open the envelopes in the order of the participants joining the group, and determine the grouping situation based on the allocation plan inside the envelopes. The N95 respirator group and the Surgical mask group were used in the two stages of cross operation. When the first round of test was completed and after a 24-hour washing out period, the subjects in the Surgical mask group and the N95 respirator group were exchanged for the second round of test. The steps and methods were the same as those in the first stage.
During the study, each candidate must correctly wear a disposable bandage type medical Surgical mask or a disposable N95 mask. After wearing, it is necessary to check whether it is worn properly and whether there is air leakage. At the beginning of the test, participants are required to avoid using masks for at least 10 minutes, measure their right index finger in a sitting position, and collect baseline (T1) data under normal breathing, including SpO2, Pulse rate (PR), RR, PetCO2, blood pressure (BP). Collect 1ml of venous blood to measure the baseline venous blood gas value.
All subjective sensations were rated using a 10 point VAS digital scale for subjective sensations such as headache, dizziness, difficulty breathing, and facial discomfort. A score of 0 indicates no discomfort, while a score of 10 indicates the most severe imaginable discomfort. Then participants were asked to wear Surgical mask or N95 mask for 4 hours to start medical work. Subsequently, immediately after using masks (T2) and continuously wearing masks for 1 hour (T3), 2 hours (T4), 3 hours (T5), and 4 hours (T6), the above data was collected using the same method. In order to minimize data variability, data was collected twice at each time point and the average was taken. After continuous wear for 4 hours, 1ml of venous blood was taken for blood gas analysis.
If the subject is unable to persist, they can immediately remove the cover and abandon the experiment; Researchers monitored these subjects until symptoms improved. Second round test: After the first round of test is completed, the second round test is conducted after a 24-hour washing period. In the second round of test, the subjects of N95 mask group and Surgical mask group in the first round of test were exchanged, and the test was conducted according to the steps and data collection methods of the first round of test.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| N95 mask group | Experimental | Device: N95 mask and surgical maskContinuously wearing N95 mask for 4 hours |
| Surgical mask group | Active comparator | Device: N95 mask and surgical maskContinuously wearing surgical mask for 4 hours |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| N95 mask and surgical maskTwenty participants were randomly assigned to the N95 mask group (n=10 ) and the Surgical mask group (n=10 ). The N95 mask group and the Surgical mask group were used in two stages alternately. When the first round of the test was completed and after a 24-hour washing out period, the participants of the Surgical mask group and the N95 respirator group were exchanged for the second round of the test. | Device | N95 mask group, Surgical mask group |
Primary outcome
PvCO2
Time frame: 4 hours
PvCO2 values in venous blood gas after wearing surgical masks or N95 masks for 4 hours
10 secondary outcomes
peripheral oxygen saturation (SpO2)
Time frame: 4 hours
pulse rate (PR)
Time frame: 4 hours
PetCO2
Time frame: 4 hours
Visual analog scale (VAS) scores
Time frame: 4 hours
PvCO2
Time frame: 0 hours
PvO2
Time frame: 0 hours，4 hours
pH
Time frame: 0 hours，4 hours
HCO3-
Time frame: 0 hours，4 hours
systolic pressure
Time frame: 6 time points before, immediately, 1h, 2h, 3h and 4h after the continuous wearing of Surgical mask or N95 mask
diastolic pressure
Time frame: 6 time points before, immediately, 1h, 2h, 3h and 4h after the continuous wearing of Surgical mask or N95 mask
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2024.
- Results publication: PubMed 32227177Luo C, Yao L, Zhang L, Yao M, Chen X, Wang Q, Shen H. Possible Transmission of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) in a Public Bath Center in Huai'an, Jiangsu Province, China. JAMA Netw Open. 2020 Mar 2;3(3):e204583. doi: 10.1001/jamanetworkopen.2020.4583.
- Results publication: PubMed 29525367O'Hara LM, Thom KA, Preas MA. Update to the Centers for Disease Control and Prevention and the Healthcare Infection Control Practices Advisory Committee Guideline for the Prevention of Surgical Site Infection (2017): A summary, review, and strategies for implementation. Am J Infect Control. 2018 Jun;46(6):602-609. doi: 10.1016/j.ajic.2018.01.018. Epub 2018 Mar 7.
- Results publication: PubMed 32932652Scheid JL, Lupien SP, Ford GS, West SL. Commentary: Physiological and Psychological Impact of Face Mask Usage during the COVID-19 Pandemic. Int J Environ Res Public Health. 2020 Sep 12;17(18):6655. doi: 10.3390/ijerph17186655.
- Results publication: PubMed 35492371Yang S, Fang C, Liu X, Liu Y, Huang S, Wang R, Qi F. Surgical Masks Affect the Peripheral Oxygen Saturation and Respiratory Rate of Anesthesiologists. Front Med (Lausanne). 2022 Apr 14;9:844710. doi: 10.3389/fmed.2022.844710. eCollection 2022.
- Results publication: PubMed 23768438Rebmann T, Carrico R, Wang J. Physiologic and other effects and compliance with long-term respirator use among medical intensive care unit nurses. Am J Infect Control. 2013 Dec;41(12):1218-23. doi: 10.1016/j.ajic.2013.02.017. Epub 2013 Jun 12.
- Results publication: PubMed 35543650Shechtman L, Ben-Haim G, Ben-Zvi I, Steel L, Ironi A, Huszti E, Chatterji S, Levy L. Physiological Effects of Wearing N95 Respirator on Medical Staff During Prolong Work Hours in Covid-19 Departments. J Occup Environ Med. 2022 Jun 1;64(6):e378-e380. doi: 10.1097/JOM.0000000000002542. Epub 2022 May 4.
- Results publication: PubMed 32588943Zhou Y, Chi J, Lv W, Wang Y. Obesity and diabetes as high-risk factors for severe coronavirus disease 2019 (Covid-19). Diabetes Metab Res Rev. 2021 Feb;37(2):e3377. doi: 10.1002/dmrr.3377. Epub 2020 Jul 20.
- Results publication: PubMed 24512862Luckhaupt SE, Cohen MA, Li J, Calvert GM. Prevalence of obesity among U.S. workers and associations with occupational factors. Am J Prev Med. 2014 Mar;46(3):237-48. doi: 10.1016/j.amepre.2013.11.002.
- Results publication: PubMed 27930484Sharma SV, Upadhyaya M, Karhade M, Baun WB, Perkison WB, Pompeii LA, Brown HS, Hoelscher DM. Are Hospital Workers Healthy?: A Study of Cardiometabolic, Behavioral, and Psychosocial Factors Associated With Obesity Among Hospital Workers. J Occup Environ Med. 2016 Dec;58(12):1231-1238. doi: 10.1097/JOM.0000000000000895.
- Results publication: PubMed 30056777Dixon AE, Peters U. The effect of obesity on lung function. Expert Rev Respir Med. 2018 Sep;12(9):755-767. doi: 10.1080/17476348.2018.1506331. Epub 2018 Aug 14.
- Derived from this study: PubMed 39994350Fang C, Ba Y, Gao Y, Liu Y, Yang S. Physiological impact of surgical masks and N95 masks on obese operating room staff. Sci Rep. 2025 Feb 24;15(1):6533. doi: 10.1038/s41598-025-91578-9.
- Individual participant dataSharing planned: Yes. After the research is completed, share research data, research plans, statistical analysis plans, informed consent forms, and other data
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shaozhong Yang, Doctor study chair
Qilu Hospital of Shandong University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing N95 mask and surgical mask in people with Obesity, run by Qilu Hospital of Shandong University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PvCO2 (time frame: 4 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05950256, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2024.