Clinical trial NCT04649775: AirFLO2 Treatment for Hypoxia and/or Tachypnea in Patients With COVID-19
Official title: AirFLO2 Treatment for Hypoxia and/or Tachypnea in Patients With COVID-19
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Corona Virus Infection
Respiratory Rate
Hypoxia
Covid19
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: MEDEX
First posted: 2020-12-02
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Unblinded, randomized, controlled trial with two arms.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Oxygenation as Measured by P:F Ratio (PaO2:FiO2)
timeFrame: Baseline, 24 hours, 48 hours
Secondary outcomes:
measure: Subject Dyspnea Symptoms
timeFrame: baseline to end of hospitalization (discharge from hospital or death, 1 - 30 days range)
measure: Change in Participant Cough Symptoms as Measured by the Leicester Cough Questionnaire (LCQ)
timeFrame: baseline to up to six hours for device intervention participants; baseline to hospital discharge (up to 30 days) for all patients
measure: Change in Participant Respiratory Symptoms as Measured by the St George Respiratory Questionnaire (SGRC)
timeFrame: baseline to up to six hours for device intervention participants; baseline to hospital discharge (up to 30 days) for all patients
measure: Number of Participants Transferred to High Flow Nasal Cannula (HFNC), Non-invasive Ventilation (NIV), or Invasive Ventilation
timeFrame: baseline to end of hospitalization (discharge from hospital or death, 1 - 30 days range)
measure: Number of Participants Transferred to the ICU
timeFrame: baseline to end of hospitalization, (discharge from hospital or death, 1 - 30 days range)
measure: Number of Participants Requiring Intubation
timeFrame: baseline to end of hospitalization (discharge from hospital or death, 1 - 30 days range)
measure: Hospitalization Length of Stay in Days
timeFrame: baseline to end of hospitalization (discharge from hospital or death, 1 - 30 days range)
measure: Number of Participants Who Survived to Discharge
timeFrame: baseline to end of hospitalization (discharge from hospital or death, 1 - 30 days expected range)
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Health System
state: North Carolina
Study officials:
affiliation: Duke Health
name: Loretta Que, MD
role: PRINCIPAL_INVESTIGATOR
References: