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

Covid19 Clinical Trial

— AirFLO2  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04649775
• Other study ID #: Pro00105246
• Status: Terminated
• Phase: N/A
• Start date: April 9, 2021
• Est. completion date: November 8, 2021

Study information

• Verified date: April 2022
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 11
• Est. completion date: November 8, 2021
• Est. primary completion date: November 8, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Corona Virus Infection
• Coronavirus Infections
• COVID-19
• Covid19
• Hypoxia
• Respiratory Rate
• Tachypnea

Intervention

Device:
• AirFLO2
Mask device

Locations

Country	Name	City	State
United States	Duke University Health System	Durham	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Duke University	MEDEX

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Oxygenation as Measured by P:F Ratio (PaO2:FiO2)	A higher P:F ratio value indicates better oxygenation. Range 20 to 500.	Baseline, 24 hours, 48 hours
Secondary	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.	baseline to end of hospitalization (discharge from hospital or death, 1 - 30 days range)
Secondary	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.	baseline to up to six hours for device intervention participants; baseline to hospital discharge (up to 30 days) for all patients
Secondary	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.	baseline to up to six hours for device intervention participants; baseline to hospital discharge (up to 30 days) for all patients
Secondary	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.	baseline to end of hospitalization (discharge from hospital or death, 1 - 30 days range)
Secondary	Number of Participants Transferred to the ICU	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)
Secondary	Number of Participants Requiring Intubation	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)
Secondary	Hospitalization Length of Stay in Days	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)
Secondary	Number of Participants Who Survived to Discharge	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)