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

Sponsor

University of Oklahoma (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT04416919

Collaborator

US Department of Veterans Affairs (U.S. Fed)

Enrollment

Location

Arm

13.4

Anticipated Duration (Months)

1.5

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Coronavirus Infection Disease Prevention	Other: Assembled mask	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

20 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

May 20, 2020

Actual Primary Completion Date :

Jun 1, 2020

Anticipated Study Completion Date :

Jul 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Other: 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.	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)

Arm

Intervention/Treatment

Other: 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.

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)

Outcome Measures

Primary Outcome Measures

Success Percentage [15 minutes]
Conduct a quantitative fit test and calculate the percentage of participants who pass the test.

Secondary Outcome Measures

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
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
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'.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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