The Effect of Wearing Masks on End-tidal Carbon Dioxide and Pulse Oximetry

NCT05114993 | Completed

• 1 other identifier: CT-2021-01
• Study Type: interventional
• Target: 119
• Locations: 1 country
• Sites: 1

Brief Summary

An Interventional Study is planned with the primary purpose of screening for changes in end-tidal carbon dioxide (ETCO2), inspired carbon dioxide (ICO2), and other vital signs that may develop after donning a disposable surgical mask. Measurements will be taken and recorded during a 5-minute control period without a mask, recording non-invasive ETCO2 and ICO2 levels by way of a nasal cannula (NC), oxygen saturation (SpO2), breaths per minute (RR), and heart rate (HR) via anesthesia equipment. This will be followed by a 15-minute intervention of wearing a disposable surgical mask and repeating measurements of ETCO2, ICO2, SpO2, RR, and HR, recorded each minute. Data will be collected from adults and children as young as 2 years of age. Age groups will include children aged 2-14 and adults aged 18 to 80, as described in the details of the research protocol. Parents and their children are invited to participate together.

Conditions

Carbon Dioxide

Keywords

surgical masks; end tidal CO2; pulse oximetry

Outcome Measures

Primary Outcomes (1)

• Potential Change in End Tidal CO2 level

  measurement of End Tidal CO2 by way of nasal cannula

  End tidal CO2 levels after 5 minutes without a mask will be compared to End Tidal CO2 levels after 15 minutes wearing a disposable surgical mask

Secondary Outcomes (4)

• Potential change in Inspired CO2 level

  Inspired CO2 levels after 5 minutes without a mask will be compared to Inspired CO2 levels after 15 minutes wearing a disposable surgical mask

• Potential change in oxygen saturation

  Oxygen saturation levels after 5 minutes without a mask will be compared to oxygen saturation levels after 15 minutes wearing a disposable surgical mask

• Potential change in respiratory rate measured in breaths per minute

  Respiratory rate after 5 minutes without a mask will be compared to respiratory rate after 15 minutes wearing a disposable surgical mask

• Potential change in Heart Rate

  Heart rate after 5 minutes without a mask will be compared to heart rate after 15 minutes wearing a disposable surgical mask

Study Arms (1)

Effects of donning a disposable surgical mask

EXPERIMENTAL

Participants will be observed and monitored without wearing a mask for a 5-minute control period. Measurements will include End Tidal CO2, Inspired CO2, Pulse Oximetry, Respiratory Rate, and Heart Rate each minute without a mask x 5 minutes. After 5 minutes, all study subjects will don the same model of disposable surgical mask. The same measurements will be taken, including End Tidal CO2, Inspired CO2, Pulse Oximetry, Respiratory Rate, and Heart Rate each minute with a mask x 15 minutes.

Device: wearing a disposable surgical mask

Interventions

wearing a disposable surgical mask DEVICE

Physiologic vital signs will be monitored every minute for 5 minutes without a mask, followed by every minute for 15 minutes with a surgical mask.

Effects of donning a disposable surgical mask

Eligibility Criteria

• Age: 2 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Good health
• Aged 2 - 14 years (inclusive) or 18 - 80 years (inclusive)

You may not qualify if:

• Significant cardiopulmonary diseases
• Intolerance to wearing nasal canula
• Intolerance to wearing a surgical mask

Sponsors & Collaborators

• Patrick Brooks: lead
• Missouri State University: collaborator

Study Sites (1)

Missouri State University

Springfield, Missouri, 65897-0027, United States

Location

Related Publications (1)

• Brooks JP, Layman J, Willis J. Physiologic effects of surgical masking in children versus adults. PeerJ. 2023 Jun 16;11:e15474. doi: 10.7717/peerj.15474. eCollection 2023.

  PMID: 37342359 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Participants will be observed and monitored for 5 minutes without any intervention. After 5 minutes of observation and monitoring, participants will don a disposable surgical mask. Participants will then be observed and monitored for 15 minutes while under the intervention of "mask-wearing". Only one type of mask will be used for all participants.

Study Record Dates

• First Submitted: October 18, 2021
• First Posted: November 10, 2021
• Study Start: November 16, 2021
• Primary Completion: January 27, 2022
• Study Completion: January 27, 2022
• Last Updated: August 24, 2022

Record last verified: 2022-08

Locations

US (1)