Ignite Creation Date:
2024-05-06 @ 3:28 PM
Last Modification Date:
2024-10-26 @ 1:50 PM
Study NCT ID:
NCT04649775
Status:
TERMINATED
Last Update Posted:
2022-11-25
First Post:
2020-10-14
Brief Title:
AirFLO2 Treatment for Hypoxia andor Tachypnea in Patients With COVID-19
Sponsor:
Duke University
Organization:
Duke University
Study Overview
Official Title:
AirFLO2 Treatment for Hypoxia andor Tachypnea in Patients With COVID-19
Status:
TERMINATED
Status Verified Date:
2022-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
no eligible participants
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
AirFLO2
Brief 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 breathsmin andor 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- PF ratio PaO2FiO2 and repeat PF 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 breathsmin andor 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
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 breathsmin andor 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None