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

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ClinicalTrials.gov Identifier: NCT04649775
Recruitment Status : Recruiting
First Posted : December 2, 2020
Last Update Posted : April 21, 2021
Sponsor:
Collaborator:
MEDEX
Information provided by (Responsible Party):
Duke University

Tracking Information
First Submitted Date  ICMJE October 14, 2020
First Posted Date  ICMJE December 2, 2020
Last Update Posted Date April 21, 2021
Actual Study Start Date  ICMJE April 9, 2021
Estimated Primary Completion Date July 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 1, 2020)
Improve hypoxia as measured by change between baseline P:F ratio and repeat P:F ratio [ Time Frame: 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 1, 2020)
  • 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.
  • Subject cough symptoms [ Time Frame: 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.
  • Subject respiratory symptoms [ Time Frame: 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.
  • Reduced risk progression of respiratory deterioration [ 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
  • Reduced risk of ICU transfer [ Time Frame: 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.
  • Reduced risk for 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)
  • Reduced hospitalization length of stay [ Time Frame: 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.
  • Increased patient survival to discharge [ Time Frame: 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)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE AirFLO2 Treatment for Hypoxia and/or Tachypnea in Patients With COVID-19
Official Title  ICMJE AirFLO2 Treatment for Hypoxia and/or Tachypnea in Patients With COVID-19
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Unblinded, randomized, controlled trial with two arms.
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Corona Virus Infection
  • Respiratory Rate
  • Hypoxia
  • Covid19
Intervention  ICMJE Device: AirFLO2
Mask device
Study Arms  ICMJE
  • 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.
    Intervention: Device: AirFLO2
  • 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.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 1, 2020)
50
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 31, 2021
Estimated Primary Completion Date July 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Catherine M Foss, BS (919) 479-0861 DukeAirwayResearch@dm.duke.edu
Contact: Maria A Santoro, MA (919) 479-0861 DukeAirwayResearch@dm.duke.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04649775
Other Study ID Numbers  ICMJE Pro00105246
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Duke University
Study Sponsor  ICMJE Duke University
Collaborators  ICMJE MEDEX
Investigators  ICMJE
Principal Investigator: Loretta Que, MD Duke University Health System
PRS Account Duke University
Verification Date April 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP