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OpenTrials
Completed

NCT Number: NCT04416919

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

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

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Key information

Conditions

Coronavirus Infection COVID-19 Coronaviridae Infections Coronavirus Infections Disease Prevention Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Oklahoma City VA Health Care System

Oklahoma City, Oklahoma, 73104, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Assembled mask

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)

Primary outcomes

  1. Success Percentage

    Time frame: 15 minutes

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

Secondary outcomes

  1. End-tidal CO2 Variation. Description: mmHg.

    Time frame: at 0 and 15 minutes

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

  2. Oxygen Pulse Oximetry Variation. Description: mmHg.

    Time frame: at 0 and 15 minutes.

    Measure the change in Oxygen Pulse Oximetry from 0 to15 minutes while wearing the Full or the Whole mask

  3. Mask Visibility. Description: Likert Scale.

    Time frame: 15 minutes

    Evaluate the visibility (5-point Likert scale from Absent to Complete) while wearing the Full or the Whole mask for 15 minutes

  4. Willingness of usage. Description: Likert Scale.

    Time frame: 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'.

Sponsors and collaborators

Lead sponsor

University of Oklahoma

Other

Collaborators

  • US Department of Veterans Affairs

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2022
First posted
Jun 4, 2020
Registry last updated
Mar 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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