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

Carbon Dioxide Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05114993
• Other study ID #: CT-2021-01
• Status: Completed
• Phase: N/A
• Start date: November 16, 2021
• Est. completion date: January 27, 2022

Study information

• Verified date: August 2022
• Source: Missouri State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 119
• Est. completion date: January 27, 2022
• Est. primary completion date: January 27, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 2 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Carbon Dioxide

Intervention

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.

Locations

Country	Name	City	State
United States	Missouri State University	Springfield	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
Patrick Brooks	Missouri State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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