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Oscillation and Lung Expansion Therapy in Patients With COVID-19

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: NCT04582214
Recruitment Status : Recruiting
First Posted : October 9, 2020
Last Update Posted : October 9, 2020
Sponsor:
Collaborators:
Emory University
Northwestern University
Information provided by (Responsible Party):
Hill-Rom

Study Description
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Brief Summary:
This is a non-randomized prospective open-label cohort study in patients with COVID-19 who require intubation and mechanical ventilation.

Condition or disease Intervention/treatment Phase
COVID-19 Oscillation and Lung Expansion Ventilation Device: MetaNeb® System Not Applicable

Detailed Description:

This is a non-randomized prospective open-label cohort study in patients with COVID-19 who require intubation and mechanical ventilation. The active treatment group will consist of patients who are treated OLE therapy while on mechanical ventilation.

Results from subjects in the active treatment group will be compared to retrospectively collected results from patients treated with standard care with no OLE therapy.

Subjects in the control group will be identified from the population of patients previously admitted to the two study sites with COVID-19 infection who required invasive mechanical ventilation but were not treated with OLE therapy. Subject data will be collected retrospectively from the medical record.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: The active treatment group will consist of patients who are treated OLE therapy while on mechanical ventilation. Results from subjects in the active treatment group will be compared to retrospectively collected results from patients treated with standard care with no OLE therapy.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Study of the Use of Oscillation and Lung Expansion (OLE) Therapy in Patients Hospitalized With COVID-19
Actual Study Start Date : September 28, 2020
Estimated Primary Completion Date : January 1, 2021
Estimated Study Completion Date : January 1, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: OLE Therapy with The MetaNeb® System
Subjects in the active treatment group will receive OLE therapy with The MetaNeb® System following the labeled instructions for the device.
 Device: MetaNeb® System
The intervention device use in this study is The MetaNeb® System (Hill-Rom; St. Paul, MN). It is an FDA 510k cleared device (k124032), powered by compressed gas, that delivers oscillation and lung expansion (OLE) therapy using both continuous high-frequency oscillation (CHFO) and continuous positive expiratory pressure (CPEP). The device also provides supplemental oxygen when used with compressed oxygen and can deliver aerosol therapy during CPEP and/or CHFO. The therapy is indicated for mobilization of secretions, lung expansion therapy and the treatment and prevention of pulmonary atelectasis. The device also provides supplemental oxygen when used with compressed oxygen.
No Intervention: Control Group
The airway clearance regimen for subjects in the control group will be collected from the medical record.This information will be retrospectively collected from patients treated with standard care with no OLE therapy. Subjects in the control group will be identified from the population of patients previously admitted to the two study sites with COVID-19 infection who required invasive mechanical ventilation but were not treated with OLE therapy.


Outcome Measures
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Primary Outcome Measures :
  1. Time on mechanical ventilation [ Time Frame: Time frame begins when the patient is first connected to mechanical ventilation and ends when they are removed from mechanical ventilation. Expected time is a a few days but not expected to exceed 3 weeks. ]
    Number of hours the patient is on mechanical ventilation


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult patient (> 18 years of age)
  • Tested positive or person under investigation (PUI) for COVID-19 infection
  • Intubated, require invasive mechanical ventilation
  • Signed informed consent (phone consent)
  • Invasive mechanical ventilation initiated within the past 24 hours

Exclusion Criteria:

  • Serious medical condition that, in the investigator's judgment, precludes the patient's safe participation in the study
  • Pressure related risk for pneumothorax
  • Patient inability or unwillingness to tolerate OLE therapy
  • Staff unavailable or unable to deliver therapy
Contacts and Locations
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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): NCT04582214


Contacts
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Contact: Brian Becker, RT 612.600.1301 brian.becker@hillrom.com
Contact: Lindsay Downing, MPH 804.307.0924 lindsay.downing@hillrom.com

Locations
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United States, Georgia
Emory University Recruiting
Atlanta, Georgia, United States, 30322
Contact: Elizabeth Cox       elizabeth.m.cox@emory.edu   
Principal Investigator: Colin Swenson, MD         
United States, Illinois
Northwestern University Recruiting
Evanston, Illinois, United States, 60208
Contact: Phill Cooper       p-cooper@northwestern.edu   
Principal Investigator: Lisa Wolfe, MD         
Sponsors and Collaborators
Hill-Rom
Emory University
Northwestern University
More Information
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Responsible Party: Hill-Rom
ClinicalTrials.gov Identifier: NCT04582214    
Other Study ID Numbers: CR-RR-2020-002
First Posted: October 9, 2020    Key Record Dates
Last Update Posted: October 9, 2020
Last Verified: October 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
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
 Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases