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
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.
Device: AirFLO2
Mask device
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
Duke University Health System
Durham, North Carolina, United States
Loretta Que, MD, Principal Investigator
Duke Health