## Protocol Section
### Identification Module
**NCT ID:** NCT06437301

**Brief Title:** End Tidal CO2 and Masks: Is There a Correlation?

**Official Title:** End Tidal CO2 and Masks: Is There a Correlation?

#### Organization Study ID Info
**ID:** 2021-057
#### Organization
**Class:** OTHER
**Full Name:** CHRISTUS Health
### Status Module
#### Completion Date
**Date:** 2022-03-16

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31

**Type:** ESTIMATED

**Last Update Submit Date:** 2024-05-24

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2021-12-31

**Type:** ACTUAL

#### Start Date
**Date:** 2021-07-01

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-31
**Type:** ESTIMATED
**Study First Submit Date:** 2024-03-07
**Study First Submit QC Date:** 2024-05-24
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** CHRISTUS Health

#### Responsible Party

**Investigator Affiliation:** CHRISTUS Health

**Investigator Full Name:** Peter Richman, MD

**Investigator Title:** Professor and Research Director

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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 Module

**Conditions:**

- End Tidal Carbon Dioxide (ETCO2)

**Keywords:**

- Hypoxia

- Respiratory Disease

- Surgical Mask

- Physiologic Capacity

- Oxygen

- Sympathetic Nerve Activity

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** CROSSOVER

**Intervention 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 Info

**Masking:** NONE

**Primary Purpose:** OTHER

#### Enrollment Info

**Count:** 31

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

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

**Intervention Names:**

- Other: Baseline measure of ETCO2 without mask

**Label:** Baseline ETCO2 without mask

**Type:** OTHER

#### Arm Group 2

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

**Intervention Names:**

- Other: Baseline ETCO2 with mask

**Label:** Baseline ETCO2 with mask

**Type:** OTHER

#### Arm Group 3

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

**Intervention Names:**

- Other: ETCO2 after 200 meter walk with mask

**Label:** ETCO2 after 200 meter walk with mask

**Type:** OTHER

#### Arm Group 4

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

**Intervention Names:**

- Other: ETCO2 after 200 meter walk without mask

**Label:** ETCO2 after 200 meter walk without mask

**Type:** OTHER

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Baseline ETCO2 without mask

**Description:** Baseline

**Name:** Baseline measure of ETCO2 without mask

**Type:** OTHER

#### Intervention 2

**Arm Group Labels:**

- Baseline ETCO2 with mask

**Description:** Mask

**Name:** Baseline ETCO2 with mask

**Type:** OTHER

#### Intervention 3

**Arm Group Labels:**

- ETCO2 after 200 meter walk with mask

**Description:** 200 meter walk and mask

**Name:** ETCO2 after 200 meter walk with mask

**Type:** OTHER

#### Intervention 4

**Arm Group Labels:**

- ETCO2 after 200 meter walk without mask

**Description:** 200 meter walk

**Name:** ETCO2 after 200 meter walk without mask

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** 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.

**Measure:** Change in end tidal carbon dioxide while wearing a mask.

**Time Frame:** Measured immediately after mask was put on.

#### Secondary Outcomes

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

**Measure:** 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.

### Eligibility Module

**Eligibility Criteria:** 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

**Healthy Volunteers:** True

**Maximum Age:** 75 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Corpus Christi

**Country:** United States

**Facility:** CHRISTUS Health-Texas A&M Spohn Emergency Medicine Residency

**State:** Texas

**Zip:** 78405

### IPD Sharing Statement Module

**IPD Sharing:** NO

### References Module

#### References

**Citation:** 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

**Citation:** 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

**Citation:** 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

#### See Also Links

**Label:** What U.S. States Require Masks In Public?

**URL:** https://masks4all.co/what-states-require-masks/

**Label:** Adverse Effects of Prolonged Mask Use among Healthcare Professionals during COVID-19

**URL:** https://clinmedjournals.org/articles/jide/journal-of-infectious-diseases-and-epidemiology-jide-6-130.php?jid=jide

## Derived Section

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BC08

- Name: Respiratory Tract (Lung and Bronchial) Diseases

### Condition Browse Module - Browse Leaves

- ID: M4185

- Name: Hypoxia

- Relevance: LOW

- As Found: Unknown

- ID: M14957

- Name: Respiration Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M14977

- Name: Respiratory Tract Diseases

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-31
