ClinicalTrials.gg
TerminatedNCT04356443Updated Oct 29, 2025

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

An observational study in Respiratory Failure, Ventilatory Failure and COVID-19, sponsored by Massachusetts General Hospital. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-10-29.

Sponsored by Massachusetts General Hospital · Observational

Why this study was terminated
Technical challenges
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
25
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Respiratory Failure
  • Ventilatory Failure
  • COVID-19
  • Pneumonia
  • ARDS, Human
03

In context

Respiratory Insufficiency

1,369 studies on the registry are indexed under Respiratory Insufficiency; 264 are open to participants now.

This study's enrollment of 25 is below the median of 100 across 455 observational studies indexed under Respiratory Insufficiency.

Browse Respiratory Insufficiency studies →

Lead sponsor

Massachusetts General Hospital is the lead sponsor of 2,586 studies on the registry; 447 are open to participants now.

Of its 222 completed or terminated interventional studies of FDA-regulated products, 168 (76%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Intubated patients
  • Pregnant women
  • Moribund patients
  • Patients who are on comfort measures (CMO)
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
25 participants (actual)
Patient registry
No

Interventions

  • DeviceAirGo 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.

06

What researchers measure

Primary outcomes

  1. Endotracheal intubation during present hospitalization, recorded through chart review

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

    Time frame: Up to three weeks

Secondary outcomes

  1. 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)

    Time frame: Up to three weeks

  2. 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

    Time frame: Up to three weeks

  3. In-hospital mortality, recorded through chart review

    Death from any cause while in the hospital

    Time frame: Up to 24 weeks

07

Study locations

1 site
  • Massachusetts General Hospital
    Boston, Massachusetts 02114, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 29, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04356443
Responsible party
Omar Hyder (Anesthesia & Critical Care Attending Physician, Massachusetts General Hospital) — Principal investigator
First posted
Apr 22, 2020
Start date
Apr 15, 2020
Primary completion
Dec 31, 2020
Completion
Dec 31, 2020
Last update
Oct 29, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Oct 2025. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion