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

End-tidal Carbon Dioxide Measurements in Adults and Children Wearing Surgical Masks

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.

Study Overview

• Status: Completed
• Conditions: Carbon Dioxide
• Intervention / Treatment: Device: wearing a disposable surgical mask

• Study Type: Interventional
• Enrollment (Actual): 119
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Springfield, Missouri, United States, 65897-0027
      • Missouri State University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 80 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: N/A
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Effects of donning a disposable surgical mask; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Potential change in Inspired CO2 level	measurement of inspired CO2 by way of nasal cannula	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	measurement of oxygen saturation by way of noninvasive pulse oximetry	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	measurement of 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	measurement of heart rate in beats per minute	Heart rate after 5 minutes without a mask will be compared to heart rate after 15 minutes wearing a disposable surgical mask

Collaborators and Investigators

• Sponsor: Patrick Brooks
• Collaborators: Missouri State University

Study record dates

Study Major Dates

• Study Start (Actual): November 16, 2021
• Primary Completion (Actual): January 27, 2022
• Study Completion (Actual): January 27, 2022

Study Registration Dates

• First Submitted: October 18, 2021
• First Submitted That Met QC Criteria: November 1, 2021
• First Posted (Actual): November 10, 2021

Study Record Updates

• Last Update Posted (Actual): August 24, 2022
• Last Update Submitted That Met QC Criteria: August 22, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: pulse oximetry; surgical masks; end tidal CO2
• Other Study ID Numbers: CT-2021-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No