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

• Conditions: Ventilatory Failure; COVID-19; ARDS, Human; Respiratory Failure; Pneumonia

• Registration Number: NCT04356443
• Lead Sponsor: Massachusetts General Hospital

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-04
• Study Start: 2020-04-15
• Study First Submitted: 2020-04-16
• Study First Submitted QC: 2020-04-19
• Last Update Submitted: 2020-04-19
• Study First Posted: 2020-04-22
• Last Update Posted: 2020-04-22
• Primary Completion: 2020-12-31
• Study Completion: 2020-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 500

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Endotracheal intubation during present hospitalization, recorded through chart review	Up to three weeks	Progression of respiratory failure to require endotracheal intubation (and mechanical ventilation)

Secondary Outcome Measures

Name	Time	Method
Premature need for removal of the band, recorded through investigator report	Up to three weeks	Patient or care provider may request removal of the band for any reason prior to the patient reaching the outcome
Improvement in hypoxemia as indicated by oxygen saturation and requirement for supplemental oxygen, recorded through chart review	Up to three weeks	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)
In-hospital mortality, recorded through chart review	Up to 24 weeks	Death from any cause while in the hospital

Trial Locations

Locations (1)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States