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NCT05950256Completed

Physiological Impact of Surgical Mask and N95 Mask on Obese Operating Room

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

Source: ClinicalTrials.gov · Last updated 20 Feb 2024

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Interventional
Enrollment
20 (actual)
First submitted
10 Jul 2023
Start date
Jul 2023
Primary completion date
Sept 2023
Lead sponsor
Qilu Hospital of Shandong University
Diseases
Obesity
NCT number
NCT05950256

What you commit to

  • Study type: Interventional
  • Participants enrolled: 20
  • From Jul 2023 to the primary completion date, Sept 2023
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Who the study is looking for

  • 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.

Age in the registry: 20 years to 60 years · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Qilu Hospital of Shandong University
Coordinator of this site? Confirm its status
JinanChinaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.