User Experience of the OSR M-1

NCT04733677 | Terminated

• 1 other identifier: IRB00070715
• Study Type: observational
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this observational study is to verify the user acceptance of the Open Standard Respirator-Model 1 (OSR-M1) by clinicians through pre-trial survey and quantitative fit-testing and post-trial feedback surveys. This study will help to guide further design modifications and clarify quantities of employee populations that may benefit from elastomeric respirator use for the deployment of OSR M1 Air Purifying Respirators (APRs) in the Wake Health network.

Conditions

Covid19

Keywords

COVID; coronavirus; respirator; mask; N99

Outcome Measures

Primary Outcomes (6)

• Percentage of Successful Fits

  Percentage of subjects that pass fit-factor testing \[0%-100%\]

  Day 1

• Quality of Fit Score

  Scores can range from 0 to 10000 with a higher score denoting a better fit. A score of 100 qualifies as a successful OSHA half-mask respirator fit test.

  Day 1

• Percentage of Participants that Fit in a Small Size Mask

  percentage \[0%-100%\]

  Day 1

• Percentage of Participants that fit in a Medium Size Mask

  percentage \[0%-100%\]

  Day 1

• Percentage of Participants that fit in a Large Size Mask

  percentage \[0%-100%\]

  Day 1

• User Acceptance Percentage

  Percentage of participants that prefer the experimental device over currently used device \[0-100%\]

  Day 10

Secondary Outcomes (1)

• Percentage of Impression Change

  Baseline through Day 10

Study Arms (1)

OSR M-1 N95

All subjects will be fitted with an OSR M1 N95 mask

Eligibility Criteria

• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Clinical staff who are issued and routinely wear N95 FFR may be screened.

You may qualify if:

• Clinical staff who are issued and routinely wear N95 FFR or equivalent APR's are eligible.

You may not qualify if:

• Participants unable to pass the fit testing will be excluded from the study.
• Anyone with a contraindication to wearing an N95 FFR (I.e. pregnancy, underlying medical conditions) will be excluded from the study.

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Wake Forest Baptist Health

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

COVID-19; Coronavirus Infections

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Philip J Brown, PhD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2021
• First Posted: February 2, 2021
• Study Start: March 19, 2021
• Primary Completion: November 15, 2022
• Study Completion: November 15, 2022
• Last Updated: March 30, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)