Clinical trial NCT04416919: 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
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: University of Oklahoma
Sponsor class: OTHER
Collaborators: name: US Department of Veterans Affairs
First posted: 2020-06-04
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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


Eligibility criteria: 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

Primary outcomes:
measure: Success Percentage
timeFrame: 15 minutes
Secondary outcomes:
measure: End-tidal CO2 Variation. Description: mmHg.
timeFrame: at 0 and 15 minutes
measure: Oxygen Pulse Oximetry Variation. Description: mmHg.
timeFrame: at 0 and 15 minutes.
measure: Mask Visibility. Description: Likert Scale.
timeFrame: 15 minutes
measure: Willingness of usage. Description: Likert Scale.
timeFrame: after 15 minutes
Other outcomes:
Locations:
city: Oklahoma City
country: United States
facility: Oklahoma City VA Health Care System
state: Oklahoma
Study officials:
affiliation: University of Oklahoma HSC - OKC Veterans Affairs Medical Center
name: Houssein Youness, MD
role: PRINCIPAL_INVESTIGATOR
References:
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
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.
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.