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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05114993
Other study ID # CT-2021-01
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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