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Completed

NCT Number: NCT05114993

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

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.

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Key information

Conditions

Carbon Dioxide

Age range

2 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Missouri State University

Springfield, Missouri, 65897-0027, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

wearing a disposable surgical mask

Device

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.

Primary outcomes

  1. Potential Change in End Tidal CO2 level

    Time frame: 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 outcomes

  1. Potential change in Inspired CO2 level

    Time frame: 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

  2. Potential change in oxygen saturation

    Time frame: 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

  3. Potential change in respiratory rate measured in breaths per minute

    Time frame: 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

  4. Potential change in Heart Rate

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Patrick Brooks

Other

Collaborators

  • Missouri State University

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Nov 10, 2021
Registry last updated
Aug 24, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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