NCT04649775

AirFLO2 Treatment for Hypoxia and/or Tachypnea in Patients With COVID-19

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: Duke University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

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.

Conditions

• Corona Virus Infection
• Respiratory Rate
• Hypoxia
• Covid19

Interventions

Type	Name	Description
DEVICE	AirFLO2	Mask device

Timeline

• Start date: 2021-04-09
• Primary completion: 2021-11-08
• Completion: 2021-11-08
• First posted: 2020-12-02
• Last updated: 2022-11-25
• Results posted: 2022-11-25

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study