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History of Changes for Study: NCT04582214
Oscillation and Lung Expansion Therapy in Patients With COVID-19
Latest version (submitted May 4, 2022) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 October 8, 2020 None (earliest Version on record)
2 May 4, 2022 Study Status, Outcome Measures, Study Design, Study Description, Contacts/Locations, Eligibility and Conditions
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Study NCT04582214
Submitted Date:  October 8, 2020 (v1)

Open or close this module Study Identification
Unique Protocol ID: CR-RR-2020-002
Brief Title: Oscillation and Lung Expansion Therapy in Patients With COVID-19
Official Title: A Pilot Study of the Use of Oscillation and Lung Expansion (OLE) Therapy in Patients Hospitalized With COVID-19
Secondary IDs:
Open or close this module Study Status
Record Verification: October 2020
Overall Status: Recruiting
Study Start: September 28, 2020
Primary Completion: January 1, 2021 [Anticipated]
Study Completion: January 1, 2021 [Anticipated]
First Submitted: October 6, 2020
First Submitted that
Met QC Criteria:
October 8, 2020
First Posted: October 9, 2020 [Actual]
Last Update Submitted that
Met QC Criteria:
October 8, 2020
Last Update Posted: October 9, 2020 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Hill-Rom
Responsible Party: Sponsor
Collaborators: Emory University
Northwestern University
Open or close this module Oversight
U.S. FDA-regulated Drug: No
U.S. FDA-regulated Device: Yes
Unapproved/Uncleared Device:
Pediatric Postmarket Surveillance:
Data Monitoring: No
Open or close this module Study Description
Brief Summary: This is a non-randomized prospective open-label cohort study in patients with COVID-19 who require intubation and mechanical ventilation.
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.

Open or close this module Conditions
Conditions: COVID-19
Oscillation and Lung Expansion
Ventilation
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Not Applicable
Interventional Study Model: Parallel Assignment
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.
Number of Arms: 2
Masking: None (Open Label)
Allocation: Non-Randomized
Enrollment: 30 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
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.
Open or close this module Outcome Measures
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
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
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
Open or close this module Contacts/Locations
Central Contact Person: Brian Becker, RT
Telephone: 612.600.1301
Email: brian.becker@hillrom.com
Central Contact Backup: Lindsay Downing, MPH
Telephone: 804.307.0924
Email: lindsay.downing@hillrom.com
Locations: United States, Georgia
Emory University
[Recruiting]
Atlanta, Georgia, United States, 30322
Contact:Contact: Elizabeth Cox elizabeth.m.cox@emory.edu
Contact:Principal Investigator: Colin Swenson, MD
United States, Illinois
Northwestern University
[Recruiting]
Evanston, Illinois, United States, 60208
Contact:Contact: Phill Cooper p-cooper@northwestern.edu
Contact:Principal Investigator: Lisa Wolfe, MD
Open or close this module IPDSharing
Plan to Share IPD: No
Open or close this module References
Citations:
Links:
Available IPD/Information:

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