Clinical trial NCT05114993: The Effect of Wearing Masks on End-tidal Carbon Dioxide and Pulse Oximetry
Official title: End-tidal Carbon Dioxide Measurements in Adults and Children Wearing Surgical Masks
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Carbon Dioxide
Keywords: surgical masks
end tidal CO2
pulse oximetry
Lead sponsor: Missouri State University
Sponsor class: OTHER
Collaborators: name: Missouri State University
First posted: 2021-11-10
Enrollment: 119
Sex: ALL
Minimum age (years): 2
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SEQUENTIAL
Intervention model description: Participants will be observed and monitored for 5 minutes without any intervention. After 5 minutes of observation and monitoring, participants will don a disposable surgical mask. Participants will then be observed and monitored for 15 minutes while under the intervention of "mask-wearing". Only one type of mask will be used for all participants.
Primary purpose: SCREENING

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.


Eligibility criteria: 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

Primary outcomes:
measure: Potential Change in End Tidal CO2 level
timeFrame: 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 outcomes:
measure: Potential change in Inspired CO2 level
timeFrame: Inspired CO2 levels after 5 minutes without a mask will be compared to Inspired CO2 levels after 15 minutes wearing a disposable surgical mask
measure: Potential change in oxygen saturation
timeFrame: Oxygen saturation levels after 5 minutes without a mask will be compared to oxygen saturation levels after 15 minutes wearing a disposable surgical mask
measure: Potential change in respiratory rate measured in breaths per minute
timeFrame: Respiratory rate after 5 minutes without a mask will be compared to respiratory rate after 15 minutes wearing a disposable surgical mask
measure: Potential change in Heart Rate
timeFrame: Heart rate after 5 minutes without a mask will be compared to heart rate after 15 minutes wearing a disposable surgical mask
Other outcomes:
Locations:
city: Springfield
country: United States
facility: Missouri State University
state: Missouri
Study officials:
References: