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

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.

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

Conditions
-----------------
Carbon Dioxide

Intervention / Treatment
-----------------
* Device: wearing a disposable surgical mask


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Screening
Intervention Model: Sequential Assignment
Interventional 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Effects of donning a disposable surgical mask<br>Participants will be observed and monitored without wearing a mask for a 5-minute control period. Measurements will include End Tidal CO2, Inspired CO2, Pulse Oximetry, Respiratory Rate, and Heart Rate each minute without a mask x 5 minutes. After 5 minutes, all study subjects will don the same model of disposable surgical mask. The same measurements will be taken, including End Tidal CO2, Inspired CO2, Pulse Oximetry, Respiratory Rate, and Heart Rate each minute with a mask x 15 minutes. | Device: wearing a disposable surgical mask<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
surgical masks, end tidal CO2, pulse oximetry