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Assessment of N-95 Facemask for Use in COVID-19 Pandemic in Case of Shortage of Personal Protective Equipment

Primary Purpose

Coronavirus Infection, Disease Prevention

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Assembled mask
Sponsored by
University of Oklahoma
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Coronavirus Infection focused on measuring 2019 novel coronavirus disease, 2019 novel coronavirus infection, COVID-19 pandemic, COVID-19 virus disease, COVID19, COVID-19 virus infection, N-95, Respiratory protective devices, Protection from respiratory infecton, Safety, Efficacy, Pandemic

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

1. All individuals older than 18 years of age, and willing to participate in the study

Exclusion Criteria:

  1. Individuals with known severe COPD/emphysema, Obesity Hypoventilation or hypercapnic condition
  2. Individuals with allergy or reactions to latex or masks
  3. Individuals reporting dyspnea or unable to breathe comfortably in these masks
  4. Claustrophobic individuals
  5. Inability to create a proper Seal while inhaling through a closed filter (See Below)
  6. Individuals who cannot safely apply and remove these masks

Sites / Locations

  • Oklahoma City VA Health Care System

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Assembled Mask

Arm Description

Participant will be fitted with a full-face mask that covers the mouth and nose or a Whole face mask that covers the eyes, nose, and mouth depending on participant's preferences. The Fitted Mask will be attached to a bacterial/viral filter for fit testing. After completing the Fit test, the mask will be placed on the face for 15 minutes while the participant performs various activities to document the ability to tolerate the respirator. Participants oxygen and carbon dioxide level will be measured in the beginning and at the end of the 15 minutes. The individuals will be able to remove the Mask anytime if they experience significant discomfort or claustrophobia. At the end, the mask will be removed.

Outcomes

Primary Outcome Measures

Success Percentage
Conduct a quantitative fit test and calculate the percentage of participants who pass the test.

Secondary Outcome Measures

End-tidal CO2 Variation. Description: mmHg.
Change in end-tidal CO2 from 0 to 15 minutes while wearing the Full or the Whole mask
Oxygen Pulse Oximetry Variation. Description: mmHg.
Measure the change in Oxygen Pulse Oximetry from 0 to15 minutes while wearing the Full or the Whole mask
Mask Visibility. Description: Likert Scale.
Evaluate the visibility (5-point Likert scale from Absent to Complete) while wearing the Full or the Whole mask for 15 minutes
Willingness of usage. Description: Likert Scale.
When the mask is removed, participants will be asked about willingness to use this mask compared to N-95 masks using a 5-point Likert scale from 'Very unlikely' to 'Very likely'.

Full Information

First Posted
May 13, 2020
Last Updated
March 4, 2021
Sponsor
University of Oklahoma
Collaborators
US Department of Veterans Affairs
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1. Study Identification

Unique Protocol Identification Number
NCT04416919
Brief Title
Assessment of N-95 Facemask for Use in COVID-19 Pandemic in Case of Shortage of Personal Protective Equipment
Official Title
A Proposed Alternative to the N-95 Mask Shortage in the COVID-19 Pandemic. A Feasibility Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Unknown status
Study Start Date
May 20, 2020 (Actual)
Primary Completion Date
June 1, 2020 (Actual)
Study Completion Date
July 1, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Oklahoma
Collaborators
US Department of Veterans Affairs

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to assess the safety and efficiency of an assembled modified mask in protecting health care workers against Coronavirus in case of any personal protective equipment shortage. At least 20 healthy participants will be recruited to try the modified mask. The modified masks will be made from masks that are already available as well as filters available in the pulmonary department at the Oklahoma City VA Health Care System

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronavirus Infection, Disease Prevention
Keywords
2019 novel coronavirus disease, 2019 novel coronavirus infection, COVID-19 pandemic, COVID-19 virus disease, COVID19, COVID-19 virus infection, N-95, Respiratory protective devices, Protection from respiratory infecton, Safety, Efficacy, Pandemic

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Assembled Mask
Arm Type
Other
Arm Description
Participant will be fitted with a full-face mask that covers the mouth and nose or a Whole face mask that covers the eyes, nose, and mouth depending on participant's preferences. The Fitted Mask will be attached to a bacterial/viral filter for fit testing. After completing the Fit test, the mask will be placed on the face for 15 minutes while the participant performs various activities to document the ability to tolerate the respirator. Participants oxygen and carbon dioxide level will be measured in the beginning and at the end of the 15 minutes. The individuals will be able to remove the Mask anytime if they experience significant discomfort or claustrophobia. At the end, the mask will be removed.
Intervention Type
Other
Intervention Name(s)
Assembled mask
Intervention Description
Assembled masks consisting of 3 parts: A facemask (Respironics Performax Whole Face Mask or Hans Rudolph mask naso-oral mask) linked by a blue elbow ( RP Performax SE ELBOW) to a ventilator filter (Teleflex Bacterial/Viral filter 1605 or Iso-Gard HEPA light Filter 28022)
Primary Outcome Measure Information:
Title
Success Percentage
Description
Conduct a quantitative fit test and calculate the percentage of participants who pass the test.
Time Frame
15 minutes
Secondary Outcome Measure Information:
Title
End-tidal CO2 Variation. Description: mmHg.
Description
Change in end-tidal CO2 from 0 to 15 minutes while wearing the Full or the Whole mask
Time Frame
at 0 and 15 minutes
Title
Oxygen Pulse Oximetry Variation. Description: mmHg.
Description
Measure the change in Oxygen Pulse Oximetry from 0 to15 minutes while wearing the Full or the Whole mask
Time Frame
at 0 and 15 minutes.
Title
Mask Visibility. Description: Likert Scale.
Description
Evaluate the visibility (5-point Likert scale from Absent to Complete) while wearing the Full or the Whole mask for 15 minutes
Time Frame
15 minutes
Title
Willingness of usage. Description: Likert Scale.
Description
When the mask is removed, participants will be asked about willingness to use this mask compared to N-95 masks using a 5-point Likert scale from 'Very unlikely' to 'Very likely'.
Time Frame
after 15 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 1. All individuals older than 18 years of age, and willing to participate in the study Exclusion Criteria: Individuals with known severe COPD/emphysema, Obesity Hypoventilation or hypercapnic condition Individuals with allergy or reactions to latex or masks Individuals reporting dyspnea or unable to breathe comfortably in these masks Claustrophobic individuals Inability to create a proper Seal while inhaling through a closed filter (See Below) Individuals who cannot safely apply and remove these masks
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Houssein Youness, MD
Organizational Affiliation
University of Oklahoma HSC - OKC Veterans Affairs Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oklahoma City VA Health Care System
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
Citation
Prevention CfDCa. Strategies for Optimizing the Supply of Facemasks: COVID-19. https://www.cdc.gov/coronavirus/2019-ncov/hcp/ppe-strategy/face-masks.html
Results Reference
background
PubMed Identifier
32182409
Citation
van Doremalen N, Bushmaker T, Morris DH, Holbrook MG, Gamble A, Williamson BN, Tamin A, Harcourt JL, Thornburg NJ, Gerber SI, Lloyd-Smith JO, de Wit E, Munster VJ. Aerosol and Surface Stability of SARS-CoV-2 as Compared with SARS-CoV-1. N Engl J Med. 2020 Apr 16;382(16):1564-1567. doi: 10.1056/NEJMc2004973. Epub 2020 Mar 17. No abstract available.
Results Reference
result
PubMed Identifier
9487666
Citation
Qian Y, Willeke K, Grinshpun SA, Donnelly J, Coffey CC. Performance of N95 respirators: filtration efficiency for airborne microbial and inert particles. Am Ind Hyg Assoc J. 1998 Feb;59(2):128-32. doi: 10.1080/15428119891010389.
Results Reference
result

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Assessment of N-95 Facemask for Use in COVID-19 Pandemic in Case of Shortage of Personal Protective Equipment

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