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

October 31, 2022 updated by: Duke University
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).

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

11

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University Health System

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Device: AirFLO2
Mask device
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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Subject Dyspnea Symptoms
Time Frame: 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.
baseline to end of hospitalization (discharge from hospital or death, 1 - 30 days range)
Change in Participant Cough Symptoms as Measured by the Leicester Cough Questionnaire (LCQ)
Time Frame: 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.
baseline to up to six hours for device intervention participants; baseline to hospital discharge (up to 30 days) for all patients
Change in Participant Respiratory Symptoms as Measured by the St George Respiratory Questionnaire (SGRC)
Time Frame: 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.
baseline to up to six hours for device intervention participants; baseline to hospital discharge (up to 30 days) for all patients
Number of Participants Transferred to High Flow Nasal Cannula (HFNC), Non-invasive Ventilation (NIV), or Invasive Ventilation
Time Frame: 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.
baseline to end of hospitalization (discharge from hospital or death, 1 - 30 days range)
Number of Participants Transferred to the ICU
Time Frame: 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
baseline to end of hospitalization, (discharge from hospital or death, 1 - 30 days range)
Number of Participants Requiring Intubation
Time Frame: 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)
baseline to end of hospitalization (discharge from hospital or death, 1 - 30 days range)
Hospitalization Length of Stay in Days
Time Frame: 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.
baseline to end of hospitalization (discharge from hospital or death, 1 - 30 days range)
Number of Participants Who Survived to Discharge
Time Frame: 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)
baseline to end of hospitalization (discharge from hospital or death, 1 - 30 days expected range)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Duke University

Collaborators

MEDEX

Investigators

  • Principal Investigator: Loretta Que, MD, Duke Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 9, 2021

Primary Completion (Actual)

November 8, 2021

Study Completion (Actual)

November 8, 2021

Study Registration Dates

First Submitted

October 14, 2020

First Submitted That Met QC Criteria

December 1, 2020

First Posted (Actual)

December 2, 2020

Study Record Updates

Last Update Posted (Actual)

November 25, 2022

Last Update Submitted That Met QC Criteria

October 31, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00105246

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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