CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 20 enrolled
Drug / intervention
N95 mask and surgical maskdevice
Likely dose
Not stated in record
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Search/NCT05950256
NCT05950256N/ACompleted

Physiological Impact of Surgical Mask and N95 Mask on Obese Operating Room Staff:A Randomized-Controlled Cross-Over Trial

Qilu Hospital of Shandong University·interventional·Posted Jul 18, 2023·Updated Feb 20, 2024

In Brief

A clinical study evaluating N95 mask and surgical mask for Obesity. Completed, enrolled 20 participants across 1 site.

Detailed 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. 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsObesity
CountriesChina
Collaborators--

Timeline

N/ACompletedFinished
202420252026
First PostedJul 18, 2023
Enrollment StartJul 19, 2023
Primary CompletionSep 30, 2023
Study CompletionJan 30, 2024
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 3.0 years ago

Interventions

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.