Non-Invasive Monitoring of Respiratory Function in Spontaneously Breathing Patients With COVID-19 Infection

Study Overview
=================
Brief Summary
-----------------
This study uses the AirGo band to monitor changes in tidal ventilation in spontaneously breathing patients with COVID-19 associated respiratory failure. It aims to recognize patterns of ventilation associated with worsening respiratory failure in this patient population. If successful, this study will lead to the development of new robust methods for real-time, continuous monitoring of respiratory function in patients with respiratory failure. In turn, such monitoring methods may enable improvements in the medical management of respiratory failure and timing of interventions.

Official Title
-----------------
Non-Invasive Monitoring of Respiratory Function in Spontaneously Breathing Patients With COVID-19 Infection

Conditions
-----------------
Respiratory Failure, Ventilatory Failure, COVID-19, Pneumonia, ARDS, Human

Intervention / Treatment
-----------------
* Device: AirGo Respiratory Monitor


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Admitted to the hospital ≥ 18 years of age Clinically suspected or confirmed COVID-19 infection Spontaneously breathing For patients not on supplemental oxygen at their location of residence prior to hospital admission, need for supplemental O2 to maintain SpO2 >=92% For patients on supplemental O2 at their location of residence prior to hospital admission, an increase in requirement of supplemental oxygen from baseline Exclusion Criteria: Intubated patients Pregnant women Moribund patients Patients who are on comfort measures (CMO)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: AirGo Respiratory Monitor|AirGo™ is composed of a wearable, miniaturized recorder unit and a medical grade Holter worn over the floating ribs of patients both at rest and during normal activity. The recorder measures live circumference changes.|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Endotracheal intubation during present hospitalization, recorded through chart review | Progression of respiratory failure to require endotracheal intubation (and mechanical ventilation) | Up to three weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in hypoxemia as indicated by oxygen saturation and requirement for supplemental oxygen, recorded through chart review | Maintenance of SpO2 >=90% on no or low flow supplemental oxygen (=< 1 liter by nasal cannula or CPAP, or return of supplemental oxygen to baseline if required supplemental O2 for another indication, prior to onset of COVID-19 infection) | Up to three weeks | 
| Premature need for removal of the band, recorded through investigator report | Patient or care provider may request removal of the band for any reason prior to the patient reaching the outcome | Up to three weeks | 
| In-hospital mortality, recorded through chart review | Death from any cause while in the hospital | Up to 24 weeks |