Ignite Creation Date:
2024-05-06 @ 3:34 PM
Last Modification Date:
2024-10-26 @ 1:51 PM
Study NCT ID:
NCT04670484
Status:
WITHDRAWN
Last Update Posted:
2022-02-08
First Post:
2020-12-10
Brief Title:
Mask Hypoxia in Subjects Using Masks to Prevent Infection Spread
Sponsor:
University of New Mexico
Organization:
University of New Mexico
Study Overview
Official Title:
To Determine the Presence of Mask Hypoxia in Subject Wearing Masks as Personal Protective Equipment PPE Due to the Federal Guidelines
Status:
WITHDRAWN
Status Verified Date:
2020-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Due to the cdc and institutional guidelines study was never started and withdrawn without any enrollment of subjects
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
There is some evidence that the use of surgical masks can induce mild hypoxia with a low level of activity eg performing surgery There is no evidence that this decrease in oxygenation is clinically significant The degree of hypoxia associated with surgical mask use N-95 mask use or the combination at rest and with exertion is unclear and warrants further investigation particularly given the current widespread use of both due to the COVID-19 pandemic Our working hypothesis is that there is a decrement in oxygenation with the use of any mask that is higher with an N-95 than a surgical mask and higher still when wearing both and that this decrement is more pronounced with exertion than at rest
Detailed Description:
Research has shown some evidence of hypoxia associated with the prolonged use of a surgical or N-95 mask Despite this the prolonged use of surgical andor N-95 masks in the clinical setting and surgical masks in the non-clinical setting is the current standard due to the COVID-19 pandemic The physiologic cost of wearing a respirator was demonstrated in healthy volunteers with mask use during heavy exertion associated with increased respiratory rate blood pressure and heart rate N95 use during light exercise increases CO2 intake reduces inspired oxygen and increases the work of breathing The physiologic effects of N95 fit testing using a hood include higher CO2 levels and lower oxygen levels in the respirator In patients with ESRD N95 mask use was associated with reduced PaO2 and increased respiratory rate The use of surgical masks for prolonged surgeries is associated with decreased SpO2 and increased heart rate particularly in those over 35 years old Many studies have suggested that there is a physiologic burden and risk of hypoxia associated with surgical andor N95 mask use This pilot study aims to compare baselines with each and both masks and with no mask versus short-duration exertion which has not yet been done per review of the literature
There is some evidence that the use of surgical masks can induce mild hypoxia with a low level of activity eg performing surgery with prolonged use There is no evidence that this decrease in oxygenation is clinically significant The degree of hypoxia associated with surgical mask use N-95 mask use or the combination at rest and with exertion is unclear and warrants further investigation particularly given the current widespread use of both due to the COVID-19 pandemic Our working hypothesis is that there is a decrement in oxygenation with the use of a mask with exertion The general public is being advised to wear a mask including those with pre-existing pulmonary disease and heart disease If there is evidence of a statistically significant decrease in oxygen saturation with short duration mask use with exertion then further studies on patients at risk for decompensation due to mask-induced hypoxia is warranted Our working hypothesis is that there is a decrement in oxygenation with the use of a mask with exertion
This is a single-site study
There is some evidence that the use of surgical masks can induce mild hypoxia with a low level of activity eg performing surgery with prolonged use There is no evidence that this decrease in oxygenation is clinically significant The degree of hypoxia associated with surgical mask use N-95 mask use or the combination at rest and with exertion is unclear and warrants further investigation particularly given the current widespread use of both due to the COVID-19 pandemic Our working hypothesis is that there is a decrement in oxygenation with the use of a mask with exertion The general public is being advised to wear a mask including those with pre-existing pulmonary disease and heart disease If there is evidence of a statistically significant decrease in oxygen saturation with short duration mask use with exertion then further studies on patients at risk for decompensation due to mask-induced hypoxia is warranted Our working hypothesis is that there is a decrement in oxygenation with the use of a mask with exertion
This is a single-site study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None