End-tidal Carbon Dioxide Measurements in Adults and Children Wearing Surgical Masks
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 119
- Locations
- 2
- Primary Endpoint
- Potential Change in End Tidal CO2 level
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Sequential
- Primary Purpose
- Screening
- Masking
- None
Eligibility Criteria
- Ages
- 2 Years to 80 Years (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Outcomes
Primary Outcomes
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
- Potential change in Inspired CO2 level(Inspired CO2 levels after 5 minutes without a mask will be compared to Inspired CO2 levels after 15 minutes wearing a disposable surgical mask)
- Potential change in respiratory rate measured in 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)
- Potential change in oxygen saturation(Oxygen saturation levels after 5 minutes without a mask will be compared to oxygen saturation levels after 15 minutes wearing a disposable surgical mask)
- Potential change in Heart Rate(Heart rate after 5 minutes without a mask will be compared to heart rate after 15 minutes wearing a disposable surgical mask)
Investigators
Patrick Brooks
Assistant Professor
Missouri State University