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

University of Oklahoma20 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Coronavirus Infection Disease Prevention

Interventions

Assembled maskOTHER

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)

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Oklahoma City VA Health Care System

Oklahoma City, Oklahoma, United States

Outcomes

Primary Outcomes

Success Percentage

Conduct a quantitative fit test and calculate the percentage of participants who pass the test.

Time frame: 15 minutes

Secondary Outcomes

End-tidal CO2 Variation. Description: mmHg.

Change in end-tidal CO2 from 0 to 15 minutes while wearing the Full or the Whole mask

Time frame: 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

Time frame: 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

Time frame: 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'.

Time frame: after 15 minutes

Data from ClinicalTrials.gov

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