NCT05114993

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 119 (actual)
• Sponsor: Patrick Brooks · Academic / Other
• Sex: All
• Age: 2 Years – 80 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-11-16
• Primary completion: 2022-01-27
• Completion: 2022-01-27
• First posted: 2021-11-10
• Last updated: 2022-08-24

Locations

1 site across 1 country: United States