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Technical challenges
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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AirGo Respiratory Monitor | Device | AirGoâ„¢ 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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This is a pilot study that aims to recruit 500 patients with respiratory failure due to COVID-19 infection at Massachusetts General Hospital.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
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| ID | Term |
|---|---|
| D012131 | Respiratory Insufficiency |
| D007040 | Hypoventilation |
| D000086382 | COVID-19 |
| D011014 | Pneumonia |
| D012128 | Respiratory Distress Syndrome |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
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| 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 |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011024 | Pneumonia, Viral |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |