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Completed

NCT Number: NCT06437301

End Tidal CO2 and Masks: Is There a Correlation?

In light of the ongoing COVID-19 pandemic, wearing a mask has become a universal standard as an attempt to reduce the spread of COVID-19. As of 2020, more than half of all U.S. states have implemented a state wide mandated mask policy. There are many schools of thought regarding the benefits and risks of donning a mask to prevent the spread of COVID-19. There is an unproven theory among some that wearing a mask interferes with our natural respiratory function, causing hypoxia, altered mental status and other various health issues. This dangerous perception has led some to believe wearing a mask is harmful, and encourages against wearing a mask in public. This theory, recently refuted by a study investigating oxygen levels while participants wore masks, performed in 2020 encouraged increased compliance with wearing masks. Another study, preformed by evaluated whether gas exchange abnormalities occurred with the use of surgical masks in subjects with and without lung function impairment. The conclusions of the study showed that regardless of lung function impairment, the presence of surgical masks did not impact gas exchange. Additionally, a more recent study concluded that the presence of a facemask did not have a significant change in physiologic parameters while during exercise. Although there is evidentiary support that facemasks do not negatively affect oxygen status and physiologic capacity, there is not strong evidence examining the relationship between ETCO2 and facemasks. The relationship between ETCO2 and facemasks is one of importance because mild decreases in oxygen have much less dangerous effects compared to the effects of rapid accumulations of carbon dioxide. Increases in end tidal carbon dioxide lead to confusion, acidosis and in severe cases, respiratory distress and failure. A study performed in 1989 showed that hypercapnia has greater increases in blood pressure, minute ventilation and sympathetic nerve activity than hypoxia.

In this newly proposed study, healthy volunteers will all wear the same type of three layer surgical mask. Their end tidal carbon dioxide will be measured while at rest without a mask, while resting with a mask and then after walking 100 meters in the mask. While previous studies have focused on changes in oxygen, there is a lack of research dedicated to analyzing end tidal carbon dioxide. This study will hope to show evidence supporting that there is no increase in end tidal carbon dioxide while wearing a mask.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHRISTUS Health-Texas A&M Spohn Emergency Medicine Residency

Corpus Christi, Texas, 78405, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy individuals between the ages of 18 and 75
  • Consent to participate in this study
  • Resident and ancillary staff

Exclusion criteria

  • Patients
  • Inability or refusal consent
  • Inability to walk the predetermined distance
  • History of lung disease
  • History of significant cardiac disease
  • People under the age of 18 and over the age of 75

Treatment and study plan

Baseline measure of ETCO2 without mask

Other

Baseline

Baseline ETCO2 with mask

Other

Mask

ETCO2 after 200 meter walk with mask

Other

200 meter walk and mask

ETCO2 after 200 meter walk without mask

Other

200 meter walk

Primary outcomes

  1. Change in end tidal carbon dioxide while wearing a mask.

    Time frame: Measured immediately after mask was put on.

    The primary objective of this study is to evaluate if there are changes present with non-invasive end tidal carbon dioxide measurement while wearing a mask.

Secondary outcomes

  1. Change in end tidal carbon dioxide while wearing a mask and walking a moderate distance.

    Time frame: Measured a time = 0 seconds after walk was completed.

    The secondary objective is to assess possible changes in end tidal carbon dioxide while walking moderate distances (200 meters) while wearing a mask.

Sponsors and collaborators

Lead sponsor

CHRISTUS Health

Other

Registry information

Important dates

Study start
2021
Primary completion
2021
Study completion
2022
First posted
May 31, 2024
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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