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

Duke University

Status: Terminated

Conditions: Corona Virus Infection; Covid19; Hypoxia; Respiratory Rate

Treatments: Device: AirFLO2

Study type: Interventional

Funder types: Other

Identifiers

NCT04649775

Pro00105246

Details and patient eligibility

About

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).

Full 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.

Enrollment: 11 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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11 participants in 2 patient groups

Device intervention

Active Comparator group

Description:

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.

Treatment:

Device: AirFLO2

Standard of Care- Control

No Intervention group

Description:

Participants will receive standard of care, clinical data will be recorded. Baseline and end of study questionnaires will be performed.