Respiratory FailureNCT04356443
Non-Invasive Monitoring of Respiratory Function in Spontaneously Breathing Patients With COVID-19 Infection
An observational study of Respiratory Failure and Ventilatory Failure, run by Massachusetts General Hospital at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Respiratory Failure, Ventilatory Failure, COVID-19
- What is being tested?
- AirGo Respiratory Monitor
- Type of treatment
- Medical device
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Apr 2020to 31 Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Intubated patients
- Pregnant women
- Moribund patients
- Patients who are on comfort measures (CMO)
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
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
- Being tested
- AirGo Respiratory Monitor
- Medical subject headings
- Respiratory Insufficiency, Hypoventilation, COVID-19, Pneumonia, Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AirGo Respiratory MonitorDevice
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Endotracheal intubation during present hospitalization, recorded through chart review
Progression of respiratory failure to require endotracheal intubation (and mechanical ventilation)
Measured: Up to three weeks
Secondary outcomes (3)
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)
Measured: 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
Measured: Up to three weeks
In-hospital mortality, recorded through chart review
Death from any cause while in the hospital
Measured: Up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2020
- Study start15 Apr 2020
- Primary completion31 Dec 2020
- Study completion31 Dec 2020
Why it stopped: Technical challenges
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory FailureStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Omar Hyder, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04356443
- Sponsor's protocol ID
- 2020P000881
- Status last verified
- Oct 2025
- First submitted
- 16 Apr 2020
- Last updated
- 29 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-Invasive Monitoring of Respiratory Function in Spontaneously Breathing Patients With COVID-19 Infection
- ClinicalTrials.gov ID
- NCT04356443
- Acronym / sponsor ID
- 2020P000881
- Conditions
- Respiratory Failure, Ventilatory Failure, COVID-19, Pneumonia, ARDS, Human
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Technical challenges
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- 15 Apr 2020 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 22 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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%
Key exclusion criteria (4 listed)
- Intubated patients
- Pregnant women
- Moribund patients
- Patients who are on comfort measures (CMO)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AirGo Respiratory MonitorAirGo™ 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. | Device | – |
Primary outcome
Endotracheal intubation during present hospitalization, recorded through chart review
Time frame: Up to three weeks
Progression of respiratory failure to require endotracheal intubation (and mechanical ventilation)
3 secondary outcomes
Improvement in hypoxemia as indicated by oxygen saturation and requirement for supplemental oxygen, recorded through chart review
Time frame: Up to three weeks
Premature need for removal of the band, recorded through investigator report
Time frame: Up to three weeks
In-hospital mortality, recorded through chart review
Time frame: Up to 24 weeks
Results and safety
The study was stopped early (reason given: Technical challenges). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Respiratory Failure and Ventilatory Failure, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 29 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Technical challenges). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Endotracheal intubation during present hospitalization, recorded through chart review (time frame: Up to three weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2025.