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

Not Applicable

Completed

• Conditions: Carbon Dioxide

• 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

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