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

Not Applicable

Completed

• Conditions: Coronavirus Infection; Disease Prevention
• Interventions: Other: Assembled mask

• Registration Number: NCT04416919
• Lead Sponsor: University of Oklahoma

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-05-13
• Study Start: 2020-05-20
• Primary Completion: 2020-06-01
• Study First Submitted QC: 2020-06-03
• Study First Posted: 2020-06-04
• Study Completion: 2022-01-20
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-07
• Last Update Posted: 2024-03-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Assembled Mask	Assembled mask	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.

Primary Outcome Measures

Name	Time	Method
Success Percentage	15 minutes	Conduct a quantitative fit test and calculate the percentage of participants who pass the test.

Secondary Outcome Measures

Name	Time	Method
End-tidal CO2 Variation. Description: mmHg.	at 0 and 15 minutes	Change in end-tidal CO2 from 0 to 15 minutes while wearing the Full or the Whole mask
Mask Visibility. Description: Likert Scale.	15 minutes	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.	after 15 minutes	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'.
Oxygen Pulse Oximetry Variation. Description: mmHg.	at 0 and 15 minutes.	Measure the change in Oxygen Pulse Oximetry from 0 to15 minutes while wearing the Full or the Whole mask

Trial Locations

Locations (1)

Oklahoma City VA Health Care System; 🇺🇸 Oklahoma City, Oklahoma, United States