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

Duke University11 enrolled

Overview

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).

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Corona Virus Infection Respiratory Rate Hypoxia Covid19

Interventions

AirFLO2DEVICE

Mask device

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Duke University Health System

Durham, North Carolina, United States

Outcomes

Primary Outcomes

Oxygenation as Measured by P:F Ratio (PaO2:FiO2)

A higher P:F ratio value indicates better oxygenation. Range 20 to 500.

Time frame: Baseline, 24 hours, 48 hours

Secondary Outcomes

Subject Dyspnea Symptoms

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.

Time frame: 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)

The Leicester Cough Questionnaire (LCQ) questionnaire has a score range of 3-21, where a higher score indicates better quality of life.

Time frame: 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)

The St George Respiratory Questionnaire (SGRC) questionnaire has a score range of 0-100, where a higher score indicates worse quality of life.

Time frame: 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

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.

Time frame: baseline to end of hospitalization (discharge from hospital or death, 1 - 30 days range)

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.