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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04356443
Recruitment Status : Recruiting
First Posted : April 22, 2020
Last Update Posted : April 22, 2020
Sponsor:
Information provided by (Responsible Party):
Omar Hyder, Massachusetts General Hospital

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.

Condition or disease Intervention/treatment
Respiratory Failure Ventilatory Failure COVID-19 Pneumonia ARDS, Human Device: AirGo Respiratory Monitor

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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Non-Invasive Monitoring of Respiratory Function in Spontaneously Breathing Patients With COVID-19 Infection
Actual Study Start Date : April 15, 2020
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020



Intervention Details:
  • Device: AirGo 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.


Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. Improvement in hypoxemia as indicated by oxygen saturation and requirement for supplemental oxygen, recorded through chart review [ Time Frame: Up to three weeks ]
    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)

  2. Premature need for removal of the band, recorded through investigator report [ Time Frame: Up to three weeks ]
    Patient or care provider may request removal of the band for any reason prior to the patient reaching the outcome

  3. In-hospital mortality, recorded through chart review [ Time Frame: Up to 24 weeks ]
    Death from any cause while in the hospital



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   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.
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04356443


Contacts
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Contact: Omar Hyder, MD, MS 617-724-0151 ohyder@partners.org
Contact: Jeanine Wiener-Kronish, MD jweiner-kronish@mgh.harvard.edu

Locations
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United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Omar Hyder, MD, MS    617-724-0151    ohyder@partners.org   
Sub-Investigator: Jeanine Wiener-Kronish, MD         
Sub-Investigator: M. Brandon Westover, MD, PhD         
Principal Investigator: Omar Hyder, MD, MS         
Sponsors and Collaborators
Massachusetts General Hospital
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Responsible Party: Omar Hyder, Anesthesia & Critical Care Attending Physician, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT04356443    
Other Study ID Numbers: 2020P000881
First Posted: April 22, 2020    Key Record Dates
Last Update Posted: April 22, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Pneumonia
Respiratory Insufficiency
Respiratory Distress Syndrome, Adult
Hypoventilation
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Respiration Disorders
Signs and Symptoms, Respiratory