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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-05-20

Study Completion Date

2022-01-20

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Medical Masks vs N95 Respirators for COVID-19

NCT04296643

Coronavirus N95 Medical Mask

COMPLETED PHASE4

Rational Use of Personal Protective Equipment During COVID-19 Pandemic

NCT04712045

Covid19 Personal Protective Equipment

COMPLETED NA

Novel Face Mask Sampling for COVID-19: A Diagnostic and Public Health Tool

NCT04481646

Covid19

UNKNOWN

The Respiratory Protection Effectiveness Clinical Trial

NCT01249625

Influenza Respiratory Syncytial Viruses Paramyxoviridae Infections +2 more

COMPLETED NA

Expanded Access to Convalescent Plasma to Treat and Prevent Pulmonary Complications Associated With COVID-19

NCT04358211

COVID-19

NO_LONGER_AVAILABLE

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Coronavirus Infection Disease Prevention

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type OTHER

Assembled mask

Intervention Type OTHER

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)

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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)

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes