AirFLO2 Treatment for Hypoxia and/or Tachypnea in Patients With COVID-19
NCT04649775 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 11
Last updated 2022-11-25
Summary
The study is an unblinded, randomized, controlled trial for use of the AirFlO2 device for patients admitted to Duke Hospital with COVID-19 and tachypnea (RR \>20 breaths/min) and/or hypoxia (Oxygen saturation \<94% on room air or requiring supplemental oxygen at baseline).
Conditions
- Corona Virus Infection
- Respiratory Rate
- Hypoxia
- Covid19
Interventions
- DEVICE
-
AirFLO2
Mask device
Sponsors & Collaborators
-
MEDEX
collaborator OTHER - lead OTHER
Principal Investigators
-
Loretta Que, MD · Duke Health
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-04-09
- Primary Completion
- 2021-11-08
- Completion
- 2021-11-08
- FDA Device
- Yes
Countries
- United States
Study Locations
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