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

Not Applicable

Completed

• Conditions: Carbon Dioxide
• Interventions: Device: wearing a disposable surgical mask

• Registration Number: NCT05114993
• Lead Sponsor: Patrick Brooks

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-10-18
• Study First Submitted QC: 2021-11-01
• Study First Posted: 2021-11-10
• Study Start: 2021-11-16
• Primary Completion: 2022-01-27
• Study Completion: 2022-01-27
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-22
• Last Update Posted: 2022-08-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 119

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Effects of donning a disposable surgical mask	wearing 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.

Primary Outcome Measures

Name	Time	Method
Potential Change in End Tidal CO2 level	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	measurement of End Tidal CO2 by way of nasal cannula

Secondary Outcome Measures

Name	Time	Method
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	measurement of inspired CO2 by way of nasal cannula
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	measurement of breaths per minute
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	measurement of oxygen saturation by way of noninvasive pulse oximetry
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	measurement of heart rate in beats per minute

Trial Locations

Locations (1)

Missouri State University; 🇺🇸 Springfield, Missouri, United States