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

University of Oklahoma (OU)

Status: Completed

Conditions: Disease Prevention; Coronavirus Infection

Treatments: Other: Assembled mask

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT04416919

11887

Details and patient eligibility

About

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

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts 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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Assembled Mask

Other group

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.

Treatment:

Other: Assembled mask