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

Patrick Brooks

Status: Completed

Conditions: Carbon Dioxide

Treatments: Device: wearing a disposable surgical mask

Study type: Interventional

Funder types: Other

Identifiers

NCT05114993

CT-2021-01

Details and patient eligibility

About

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.

Enrollment: 119 patients

Sex: All

Ages: 2 to 80 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: N/A

Interventional model: Sequential Assignment

Masking: None (Open label)

---

119 participants in 1 patient group

Effects of donning a disposable surgical mask

Experimental group

Description:

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.

Treatment:

Device: wearing a disposable surgical mask