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

Study Overview
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Brief Summary
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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

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

Conditions
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Coronavirus Infection, Disease Prevention

Intervention / Treatment
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* Other: Assembled mask


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1. All individuals older than 18 years of age, and willing to participate in the study Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Assembled Mask<br>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<br>* 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)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Success Percentage | Conduct a quantitative fit test and calculate the percentage of participants who pass the test. | 15 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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. | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COVID19, 2019 novel coronavirus disease, 2019 novel coronavirus infection, COVID-19 pandemic, COVID-19 virus disease, COVID-19 virus infection, N-95, Respiratory protective devices, Protection from respiratory infecton, Safety, Efficacy, Pandemic