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

Sponsor
Duke University (Other)
Overall Status
Terminated
CT.gov ID
NCT04649775
Collaborator
MEDEX (Other)
11
1
2
7
1.6

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
  • Device: AirFLO2
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
11 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Unblinded, randomized, controlled trial with two arms.Unblinded, randomized, controlled trial with two arms.
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
AirFLO2 Treatment for Hypoxia and/or Tachypnea in Patients With COVID-19
Actual Study Start Date :
Apr 9, 2021
Actual Primary Completion Date :
Nov 8, 2021
Actual Study Completion Date :
Nov 8, 2021

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Improve hypoxia as measured by change between baseline P:F ratio and repeat P:F ratio [change from baseline compared to one to six hours after initial device intervention]

    Improve hypoxia as measured by change between baseline P:F ratio and repeat P:F ratio inspired oxygen- P:F ratio (PaO2:FiO2), a higher value indicates better oxygenation. Range 20 to 500.

Secondary Outcome Measures

  1. 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.

  2. Subject cough symptoms [baseline to up to six hours for device intervention participants; baseline to hospital discharge (up to 30 days) for all patients]

    Improved symptoms related to cough as measured by the change in Leicester Cough Questionnaire (LCQ) questionnaire, score range 3-21, a higher score indicates better quality of life.

  3. Subject respiratory symptoms [baseline to up to six hours for device intervention participants; baseline to hospital discharge (up to 30 days) for all patients]

    Improve subjective symptoms related to cough as measured by the change in St George Respiratory Questionnaire (SGRC) questionnaire, score range 0-100, a higher score indicates worse quality of life.

  4. Reduced risk progression of respiratory deterioration [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

  5. Reduced risk of ICU transfer [baseline to end of hospitalization, (discharge from hospital or death, 1 - 30 days range)]

    Reduced intensive care unit (ICU) transfer risk, as measured by a change from baseline to end of hospitalization of ICU admission.

  6. Reduced risk for 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)

  7. Reduced hospitalization length of stay [baseline to end of hospitalization, (discharge from hospital or death, 1 - 30 days range)]

    Reduced hospitalization length of stay as measured by length of hospitalization after the baseline timepoint.

  8. Increased patient survival to discharge [baseline to end of hospitalization, (discharge from hospital- 1 - 30 days expected range)]

    Increased patient survival to hospital discharge as measured by the participant status at the end of the hospitalization (discharge or death)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Duke University Health System Durham North Carolina United States 27710

Sponsors and Collaborators

  • Duke University
  • MEDEX

Investigators

  • Principal Investigator: Loretta Que, MD, Duke Health

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Duke University
ClinicalTrials.gov Identifier:
NCT04649775
Other Study ID Numbers:
  • Pro00105246
First Posted:
Dec 2, 2020
Last Update Posted:
Apr 22, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 22, 2022