Mask Hypoxia in Subjects Using Masks to Prevent Infection Spread

NCT04670484 | Withdrawn

• 1 other identifier: 20-456
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

There is some evidence that the use of surgical masks can induce mild hypoxia with a low level of activity (e.g. 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.

Conditions

Hypoxia

Keywords

hypoxia; mask

Outcome Measures

Primary Outcomes (1)

• Hypoxia

  Decrease from baseline oxygenation from 70-80% of predicted maximum

  one year

Study Arms (1)

Healthy subjects wearing masks

OTHER

Subjects wearing masks to prevent coronavirus infection spread in COVID19 pandemic

Other: Wearing Mask

Interventions

Wearing Mask OTHER

Participants wearing masks as per federal guidelines to prevent Coronavirus spread

Healthy subjects wearing masks

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects 18 years old and up wearing masks as personal protective equipment (measure)

You may not qualify if:

• Subjects younger than 18 years old.
• Females who are pregnant or women of childbearing potential with a positive pregnancy test at the time of consenting. (If a pregnancy test has not been performed at the time of consenting, the individual will be automatically excluded since a confirmed negative pregnancy test is not available. We will not be able to provide the cost of pregnancy test and will only rely on verbal confirmation from the subject that they are not pregnant or have a -personally purchased standard of care- negative pregnancy test.)
• Consent cannot be obtained from the subject
• Prisoners will be excluded
• Cognitively impaired subjects will be excluded.

Sponsors & Collaborators

• University of New Mexico: lead

MeSH Terms

Conditions

Hypoxia

Condition Hierarchy (Ancestors)

Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2020
• First Posted: December 17, 2020
• Study Start: December 1, 2020
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: February 8, 2022

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share