End Tidal CO2 and Masks: Is There a Correlation?

NCT06437301 | Completed

• 1 other identifier: 2021-057
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hypercapnia

Keywords

Hypoxia; Respiratory Disease; Surgical Mask; Physiologic Capacity; Oxygen; Sympathetic Nerve Activity

Outcome Measures

Primary Outcomes (1)

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

  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.

  Measured immediately after mask was put on.

Secondary Outcomes (1)

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

  Measured a time = 0 seconds after walk was completed.

Study Arms (4)

Baseline ETCO2 without mask

OTHER

Subjects will have their baseline end tidal carbon dioxide measured while at rest and without a mask.

Other: Baseline measure of ETCO2 without mask

Baseline ETCO2 with mask

OTHER

The second measurement will also occur at rest, but while subjects are wearing a mask.

Other: Baseline ETCO2 with mask

ETCO2 after 200 meter walk with mask

OTHER

Lastly, end tidal carbon dioxide will be measured after each participant walks 200 meters, with a surgical mask.

Other: ETCO2 after 200 meter walk with mask

ETCO2 after 200 meter walk without mask

OTHER

Lastly, end tidal carbon dioxide will be measured after each participant walks 200 meters, without a surgical mask.

Other: ETCO2 after 200 meter walk without mask

Interventions

Baseline measure of ETCO2 without mask OTHER

Baseline

Baseline ETCO2 without mask

Baseline ETCO2 with mask OTHER

Mask

Baseline ETCO2 with mask

ETCO2 after 200 meter walk with mask OTHER

200 meter walk and mask

ETCO2 after 200 meter walk with mask

ETCO2 after 200 meter walk without mask OTHER

200 meter walk

ETCO2 after 200 meter walk without mask

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• CHRISTUS Health: lead

Study Sites (1)

CHRISTUS Health-Texas A&M Spohn Emergency Medicine Residency

Corpus Christi, Texas, 78405, United States

Location

Related Publications (4)

• Chan NC, Li K, Hirsh J. Peripheral Oxygen Saturation in Older Persons Wearing Nonmedical Face Masks in Community Settings. JAMA. 2020 Dec 8;324(22):2323-2324. doi: 10.1001/jama.2020.21905.

  PMID: 33125030 RESULT

• Barbeito-Caamano C, Bouzas-Mosquera A, Peteiro J, Lopez-Vazquez D, Quintas-Guzman M, Varela-Cancelo A, Martinez-Ruiz D, Yanez-Wonenburger JC, Pineiro-Portela M, Vazquez-Rodriguez JM. Exercise testing in COVID-19 era: Clinical profile, results and feasibility wearing a facemask. Eur J Clin Invest. 2021 Apr;51(4):e13509. doi: 10.1111/eci.13509. Epub 2021 Feb 15.

  PMID: 33548060 RESULT

• Samannan R, Holt G, Calderon-Candelario R, Mirsaeidi M, Campos M. Effect of Face Masks on Gas Exchange in Healthy Persons and Patients with Chronic Obstructive Pulmonary Disease. Ann Am Thorac Soc. 2021 Mar;18(3):541-544. doi: 10.1513/AnnalsATS.202007-812RL. No abstract available.

  PMID: 33003954 RESULT

• Somers VK, Mark AL, Zavala DC, Abboud FM. Contrasting effects of hypoxia and hypercapnia on ventilation and sympathetic activity in humans. J Appl Physiol (1985). 1989 Nov;67(5):2101-6. doi: 10.1152/jappl.1989.67.5.2101.

  PMID: 2513316 RESULT

Related Links

• What U.S. States Require Masks In Public?
• Adverse Effects of Prolonged Mask Use among Healthcare Professionals during COVID-19

MeSH Terms

Conditions

Hypercapnia; Hypoxia; Respiration Disorders

Interventions

Masks

Condition Hierarchy (Ancestors)

Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Surgical Attire; Equipment and Supplies, Hospital; Equipment and Supplies; Protective Devices; Personal Protective Equipment; Surgical Equipment; Manufactured Materials; Technology, Industry, and Agriculture

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Research Director

Model Details: This study is a prospective, controlled study involving healthy adult volunteers all of whom are resident and faculty physicians, or other medical staff. There will be no financial compensation.

Study Record Dates

• First Submitted: March 7, 2024
• First Posted: May 31, 2024
• Study Start: July 1, 2021
• Primary Completion: December 31, 2021
• Study Completion: March 16, 2022
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)