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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04356443
Other study ID # 2020P000881
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date April 15, 2020
Est. completion date December 31, 2020

Study information

Verified date April 2020
Source Massachusetts General Hospital
Contact Omar Hyder, MD, MS
Phone 617-724-0151
Email ohyder@partners.org
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 500
Est. completion date December 31, 2020
Est. primary completion date December 31, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
United States Massachusetts General Hospital Boston Massachusetts

Sponsors (1)

Lead Sponsor Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
Secondary 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
Secondary In-hospital mortality, recorded through chart review Death from any cause while in the hospital Up to 24 weeks
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