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

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.

Study Overview

• Status: Unknown
• Conditions: COVID-19; Pneumonia; Respiratory Failure; ARDS, Human; Ventilatory Failure
• Intervention / Treatment: Device: AirGo Respiratory Monitor

• Study Type: Observational
• Enrollment (Anticipated): 500

Contacts and Locations

• Study Contact: Name: Omar Hyder, MD, MS; Phone Number: 617-724-0151; Email: ohyder@partners.org
• Study Contact Backup: Name: Jeanine Wiener-Kronish, MD; Email: jweiner-kronish@mgh.harvard.edu

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Recruiting
      • Massachusetts General Hospital
      • Contact: Omar Hyder, MD, MS; Phone Number: 617-724-0151; Email: ohyder@partners.org
      • Sub-Investigator: Jeanine Wiener-Kronish, MD
      • Sub-Investigator: M. Brandon Westover, MD, PhD
      • Principal Investigator: Omar Hyder, MD, MS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
In-hospital mortality, recorded through chart review	Death from any cause while in the hospital	Up to 24 weeks

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 15, 2020
• Primary Completion (ANTICIPATED): December 31, 2020
• Study Completion (ANTICIPATED): December 31, 2020

Study Registration Dates

• First Submitted: April 16, 2020
• First Submitted That Met QC Criteria: April 19, 2020
• First Posted (ACTUAL): April 22, 2020

Study Record Updates

• Last Update Posted (ACTUAL): April 22, 2020
• Last Update Submitted That Met QC Criteria: April 19, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Respiration Disorders; Pneumonia, Viral; Pneumonia; Lung Diseases; Signs and Symptoms, Respiratory; COVID-19; Respiratory Insufficiency; Respiratory Distress Syndrome; Hypoventilation
• Other Study ID Numbers: 2020P000881

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No