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

Massachusetts General Hospital25 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Respiratory Failure Ventilatory Failure COVID-19 Pneumonia ARDS, Human

Interventions

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Outcomes

Primary Outcomes

Endotracheal intubation during present hospitalization, recorded through chart review

Progression of respiratory failure to require endotracheal intubation (and mechanical ventilation)

Time frame: Up to three weeks

Secondary Outcomes

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)

Time frame: 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

Time frame: Up to three weeks

In-hospital mortality, recorded through chart review

Death from any cause while in the hospital

Time frame: Up to 24 weeks

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes