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Purpose

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

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
Yes

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

Phase
N/A
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Prevention
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
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)

Recruiting Locations

More Details

NCT ID
NCT04416919
Status
Completed
Sponsor
University of Oklahoma

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.