Carbon Dioxide
Conditions
Keywords
surgical masks, end tidal CO2, pulse oximetry
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.
Interventions
DEVICEwearing 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.
Sponsors
Missouri State University
Patrick Brooks
Study design
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
SCREENING
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
2 Years to 80 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Potential Change in End Tidal CO2 level | 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | measurement of inspired CO2 by way of nasal cannula |
| 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 | measurement of oxygen saturation by way of noninvasive pulse oximetry |
| 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 | measurement of breaths per minute |
| 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 | measurement of heart rate in beats per minute |
Countries
United States
Outcome results
None listed