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

COVID-19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04356443
• Other study ID #: 2020P000881
• Status: Recruiting
• 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
• 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)

Related Conditions & MeSH terms

• ARDS, Human
• COVID-19
• Hypoventilation
• Pneumonia
• Respiratory Distress Syndrome, Adult
• Respiratory Failure
• Respiratory Insufficiency
• Ventilatory Failure

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