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

NCT04356443 | Terminated FDA Device

• 1 other identifier: 2020P000881
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Respiratory Failure; Ventilatory Failure; COVID-19; Pneumonia; ARDS, Human

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Improvement in hypoxemia as indicated by oxygen saturation and requirement for supplemental oxygen, recorded through chart review

  Up to three weeks

• Premature need for removal of the band, recorded through investigator report

  Up to three weeks

• In-hospital mortality, recorded through chart review

  Up to 24 weeks

Interventions

AirGo Respiratory Monitor DEVICE

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 Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This is a pilot study that aims to recruit 500 patients with respiratory failure due to COVID-19 infection at Massachusetts General Hospital.

You may qualify if:

• 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

You may not qualify if:

• Intubated patients
• Pregnant women
• Moribund patients
• Patients who are on comfort measures (CMO)

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Respiratory Insufficiency; Hypoventilation; COVID-19; Pneumonia; Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pneumonia, Viral; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anesthesia & Critical Care Attending Physician

Study Record Dates

• First Submitted: April 16, 2020
• First Posted: April 22, 2020
• Study Start: April 15, 2020
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: October 29, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)