HypercapniaNCT06437301
End Tidal CO2 and Masks: Is There a Correlation?
A study testing Baseline measure of ETCO2 without mask, Baseline ETCO2 with mask and ETCO2 after 200 meter walk with mask in people with Hypercapnia, run by CHRISTUS Health at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypercapnia
- What is being tested?
- Baseline measure of ETCO2 without mask, Baseline ETCO2 with mask and ETCO2 after 200 meter walk with mask
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2021to 16 Mar 2022
- 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 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy individuals between the ages of 18 and 75
- Consent to participate in this study
- Resident and ancillary staff
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
CHRISTUS Health-Texas A&M Spohn Emergency Medicine Residency
Corpus Christi, Texas, 78405
About this study
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
- Being tested
- Baseline measure of ETCO2 without mask, Baseline ETCO2 with mask, ETCO2 after 200 meter walk with mask, ETCO2 after 200 meter walk without mask
- Keywords
- Hypoxia, Respiratory Disease, Surgical Mask, Physiologic Capacity, Oxygen, Sympathetic Nerve Activity
- Medical subject headings
- Hypercapnia, Hypoxia, Respiration Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Baseline measure of ETCO2 without maskOther
Baseline
Baseline ETCO2 with maskOther
Mask
ETCO2 after 200 meter walk with maskOther
200 meter walk and mask
ETCO2 after 200 meter walk without maskOther
200 meter walk
| Study group | Role | What they receive |
|---|---|---|
| Baseline ETCO2 without mask | Other | Subjects will have their baseline end tidal carbon dioxide measured while at rest and without a mask. Receives: 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. Receives: 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. Receives: 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. Receives: Other: ETCO2 after 200 meter walk without mask |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: 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.
The secondary objective is to assess possible changes in end tidal carbon dioxide while walking moderate distances (200 meters) while wearing a mask.
Measured: Measured a time = 0 seconds after walk was completed.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2024
- Study start1 Jul 2021
- Primary completion31 Dec 2021
- Study completion16 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for HypercapniaStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- CHRISTUS Health
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peter Richman, MD, CHRISTUS Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06437301
- Sponsor's protocol ID
- 2021-057
- Status last verified
- Sep 2024
- First submitted
- 7 Mar 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33125030Barbeito-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.
PubMed 33548060Samannan 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.
PubMed 33003954Somers 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.
PubMed 2513316
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- End Tidal CO2 and Masks: Is There a Correlation?
- ClinicalTrials.gov ID
- NCT06437301
- Acronym / sponsor ID
- 2021-057
- Conditions
- Hypercapnia
- Keywords
- Hypoxia, Respiratory Disease, Surgical Mask, Physiologic Capacity, Oxygen, Sympathetic Nerve Activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- CHRISTUS HealthUniversity, hospital or other
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 16 Mar 2022 (actual)
- First posted
- 31 May 2024 (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.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Baseline ETCO2 without mask | Other | Other: Baseline measure of ETCO2 without maskSubjects will have their baseline end tidal carbon dioxide measured while at rest and without a mask. |
| Baseline ETCO2 with mask | Other | Other: Baseline ETCO2 with maskThe second measurement will also occur at rest, but while subjects are wearing a mask. |
| ETCO2 after 200 meter walk with mask | Other | Other: ETCO2 after 200 meter walk with maskLastly, end tidal carbon dioxide will be measured after each participant walks 200 meters, with a surgical mask. |
| ETCO2 after 200 meter walk without mask | Other | Other: ETCO2 after 200 meter walk without maskLastly, end tidal carbon dioxide will be measured after each participant walks 200 meters, without a surgical mask. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Healthy individuals between the ages of 18 and 75
- Consent to participate in this study
- Resident and ancillary staff
Key exclusion criteria (6 listed)
- Patients
- Inability or refusal consent
- Inability to walk the predetermined distance
- History of lung disease
- History of significant cardiac disease
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 |
|---|---|---|
| Baseline measure of ETCO2 without maskBaseline | Other | Baseline ETCO2 without mask |
| Baseline ETCO2 with maskMask | Other | Baseline ETCO2 with mask |
| ETCO2 after 200 meter walk with mask200 meter walk and mask | Other | ETCO2 after 200 meter walk with mask |
| ETCO2 after 200 meter walk without mask200 meter walk | Other | ETCO2 after 200 meter walk without mask |
Primary outcome
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.
1 secondary outcome
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.
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 19 Sep 2024.
- Results publication: PubMed 33125030Chan 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.
- Results publication: PubMed 33548060Barbeito-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.
- Results publication: PubMed 33003954Samannan 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.
- Results publication: PubMed 2513316Somers 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.
- What U.S. States Require Masks In Public?Link provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Baseline measure of ETCO2 without mask, Baseline ETCO2 with mask and ETCO2 after 200 meter walk with mask in people with Hypercapnia, run by CHRISTUS Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. 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 19 Sep 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 United States. 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?
Change in end tidal carbon dioxide while wearing a mask. (time frame: Measured immediately after mask was put on.). 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 NCT06437301, which also lists 4 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 19 Sep 2024.