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

Not Applicable

Terminated

• Conditions: Corona Virus Infection; Hypoxia; Covid19; Respiratory Rate
• Interventions: Device: AirFLO2

• Registration Number: NCT04649775
• Lead Sponsor: Duke University

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 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.

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study First Submitted: 2020-10-14
• Study First Submitted QC: 2020-12-01
• Study First Posted: 2020-12-02
• Study Start: 2021-04-09
• Primary Completion: 2021-11-08
• Study Completion: 2021-11-08
• Status Verified: 2022-04
• Results First Submitted: 2022-10-31
• Results First Submitted QC: 2022-10-31
• Last Update Submitted: 2022-10-31
• Results First Posted: 2022-11-25
• Last Update Posted: 2022-11-25

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 11

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Device intervention	AirFLO2	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.

Primary Outcome Measures

Name	Time	Method
Oxygenation as Measured by P:F Ratio (PaO2:FiO2)	Baseline, 24 hours, 48 hours	A higher P:F ratio value indicates better oxygenation. Range 20 to 500.

Secondary Outcome Measures

Name	Time	Method
Change in Participant Cough Symptoms as Measured by the Leicester Cough Questionnaire (LCQ)	baseline to up to six hours for device intervention participants; baseline to hospital discharge (up to 30 days) for all patients	The Leicester Cough Questionnaire (LCQ) questionnaire has a score range of 3-21, where a higher score indicates better quality of life.
Number of Participants Transferred to the ICU	baseline to end of hospitalization, (discharge from hospital or death, 1 - 30 days range)	Reduced intensive care unit (ICU) transfer risk occurring between baseline and end of hospitalization
Number of Participants Who Survived to Discharge	baseline to end of hospitalization (discharge from hospital or death, 1 - 30 days expected range)	Patient survival to hospital discharge as measured by the participant status at the end of the hospitalization (discharge or death)
Hospitalization Length of Stay in Days	baseline to end of hospitalization (discharge from hospital or death, 1 - 30 days range)	Hospitalization length of stay as measured by length of hospitalization after the baseline timepoint.
Subject Dyspnea Symptoms	baseline to end of hospitalization (discharge from hospital or death, 1 - 30 days range)	Improved symptoms related to dyspnea as measured by the change in the Modified Medical Research Council (MMRC).. Range 0 to 4 with lower values being better.
Change in Participant Respiratory Symptoms as Measured by the St George Respiratory Questionnaire (SGRC)	baseline to up to six hours for device intervention participants; baseline to hospital discharge (up to 30 days) for all patients	The St George Respiratory Questionnaire (SGRC) questionnaire has a score range of 0-100, where a higher score indicates worse quality of life.
Number of Participants Transferred to High Flow Nasal Cannula (HFNC), Non-invasive Ventilation (NIV), or Invasive Ventilation	baseline to end of hospitalization (discharge from hospital or death, 1 - 30 days range)	Reduce risk of respiratory deterioration as measured by change from baseline to end of hospitalization (discharge or patient death) to high flow nasal cannula (HFNC), non-invasive ventilation (NIV), or invasive ventilation.
Number of Participants Requiring Intubation	baseline to end of hospitalization (discharge from hospital or death, 1 - 30 days range)	Reduce risk for intubation requirement as measured by incidence of intubation occurring between baseline and end of hospitalization (discharge or death)

Trial Locations

Locations (1)

Duke University Health System; 🇺🇸 Durham, North Carolina, United States