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Clinical Trials/NCT04356443
NCT04356443
Terminated
N/A

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

Massachusetts General Hospital1 site in 1 country25 target enrollmentApril 15, 2020

Overview

Phase
N/A
Intervention
Not specified
Conditions
Respiratory Failure
Sponsor
Massachusetts General Hospital
Enrollment
25
Locations
1
Primary Endpoint
Endotracheal intubation during present hospitalization, recorded through chart review
Status
Terminated
Last Updated
6 months ago

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.

Registry
clinicaltrials.gov
Start Date
April 15, 2020
End Date
December 31, 2020
Last Updated
6 months ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Omar Hyder

Anesthesia & Critical Care Attending Physician

Massachusetts General Hospital

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)

Outcomes

Primary Outcomes

Endotracheal intubation during present hospitalization, recorded through chart review

Time Frame: Up to three weeks

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

Secondary Outcomes

  • Premature need for removal of the band, recorded through investigator report(Up to three weeks)
  • Improvement in hypoxemia as indicated by oxygen saturation and requirement for supplemental oxygen, recorded through chart review(Up to three weeks)
  • In-hospital mortality, recorded through chart review(Up to 24 weeks)

Study Sites (1)

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