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

Coronavirus Infection Clinical Trial

Official title:

A Proposed Alternative to the N-95 Mask Shortage in the COVID-19 Pandemic. A Feasibility Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04416919
• Other study ID #: 11887
• Status: Completed
• Phase: N/A
• Start date: May 20, 2020
• Est. completion date: January 20, 2022

Study information

• Verified date: March 2024
• Source: University of Oklahoma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: January 20, 2022
• Est. primary completion date: June 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronavirus Infection
• Coronavirus Infections
• COVID-19
• Disease Prevention
• Infections

Intervention

Other:
• Assembled mask
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)

Locations

Country	Name	City	State
United States	Oklahoma City VA Health Care System	Oklahoma City	Oklahoma

Sponsors (2)

Lead Sponsor	Collaborator
University of Oklahoma	US Department of Veterans Affairs

Country where clinical trial is conducted

United States, 

References & 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

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. — View 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Success Percentage	Conduct a quantitative fit test and calculate the percentage of participants who pass the test.	15 minutes
Secondary	End-tidal CO2 Variation. Description: mmHg.	Change in end-tidal CO2 from 0 to 15 minutes while wearing the Full or the Whole mask	at 0 and 15 minutes
Secondary	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	at 0 and 15 minutes.
Secondary	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	15 minutes
Secondary	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'.	after 15 minutes