Coronavirus Infection, Disease Prevention
Conditions
Keywords
2019 novel coronavirus disease, 2019 novel coronavirus infection, COVID-19 pandemic, COVID-19 virus disease, COVID19, COVID-19 virus infection, N-95, Respiratory protective devices, Protection from respiratory infecton, Safety, Efficacy, Pandemic
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
Interventions
OTHERAssembled 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)
Sponsors
US Department of Veterans Affairs
University of Oklahoma
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Success Percentage | 15 minutes | Conduct a quantitative fit test and calculate the percentage of participants who pass the test. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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'. |
Countries
United States
Outcome results
None listed