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

NCT04416919 | Completed

• 1 other identifier: 11887
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Success Percentage

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

  15 minutes

Secondary Outcomes (4)

• End-tidal CO2 Variation. Description: mmHg.

  at 0 and 15 minutes

• Oxygen Pulse Oximetry Variation. Description: mmHg.

  at 0 and 15 minutes.

• Mask Visibility. Description: Likert Scale.

  15 minutes

• Willingness of usage. Description: Likert Scale.

  after 15 minutes

Study Arms (1)

Assembled Mask

OTHER

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.

Other: Assembled mask

Interventions

Assembled mask OTHER

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)

Assembled Mask

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Oklahoma: lead
• US Department of Veterans Affairs: collaborator

Study Sites (1)

Oklahoma City VA Health Care System

Oklahoma City, Oklahoma, 73104, United States

Location

Related Publications (3)

• Prevention CfDCa. Strategies for Optimizing the Supply of Facemasks: COVID-19. https://www.cdc.gov/coronavirus/2019-ncov/hcp/ppe-strategy/face-masks.html

  BACKGROUND

• 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.

  PMID: 32182409 RESULT

• 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.

  PMID: 9487666 RESULT

MeSH Terms

Conditions

Coronavirus Infections; COVID-19

Condition Hierarchy (Ancestors)

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

Study Officials

• Houssein Youness, MD

  University of Oklahoma HSC - OKC Veterans Affairs Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: May 13, 2020
• First Posted: June 4, 2020
• Study Start: May 20, 2020
• Primary Completion: June 1, 2020
• Study Completion: January 20, 2022
• Last Updated: March 8, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)