AirFLO2 Treatment for Hypoxia and/or Tachypnea in Patients With COVID-19
Purpose
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
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Adults ≥18 years of age with confirmed COVID-19 infection - Patient must be able to complete consent and hold mask - Baseline room air oxygen saturation <94% or new supplemental oxygen requirement at presentation or patient on supplemental oxygen at baseline and requiring up-titration of oxygen setting - Patient in negative pressure room - Patient must have access to an internet-connected device
Exclusion Criteria
- Tracheostomy - History of pneumothorax or known bullous lung disease - Recent cataract surgery - Patient receiving NIV (Noninvasive Ventilation) or HFNC (High Flow Nasal Cannula) - Patient receiving mechanical ventilation - Delirium
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Intervention Model Description
- Unblinded, randomized, controlled trial with two arms.
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Active Comparator Device intervention |
Intervention participants will receive the AirFLO2 device and training via video with reinforcement from the coordinator how to use and to self-apply it. Clinical data will be recorded before and after intervention. Questionnaires will be completed at baseline and at serial time points after intervention starts. |
|
|
No Intervention Standard of Care- Control |
Participants will receive standard of care, clinical data will be recorded. Baseline and end of study questionnaires will be performed. |
|
Recruiting Locations
More Details
- NCT ID
- NCT04649775
- Status
- Terminated
- Sponsor
- Duke University
Detailed Description
The aim of the study is to determine whether the use of the AirFLO2 device can improve hypoxia as measured by change between partial pressure of arterial oxygen to fraction of inspired oxygen- P:F ratio (PaO2:FiO2) and repeat P:F ratio between 1 to 6 hours after using the device. This 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). Groups will be analyzed by intention to treat. Per-protocol analyses will also be performed. Descriptive statistics will be reported for the overall subject population, and for the two groups.