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Oscillation and Lung Expansion Therapy in Patients With COVID-19

Primary Purpose

COVID-19, Oscillation and Lung Expansion

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
MetaNeb® System
Sponsored by
Hill-Rom
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COVID-19

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Adult patient (> 18 years of age)
  • Tested positive or person under investigation (PUI) for COVID-19 infection
  • Currently require heated high-flow oxygen therapy to maintain SaO2 > 90 %
  • Signed informed consent (phone consent)
  • Heated high-flow oxygen initiated within the past 72 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
  • Current requirement for mechanical ventilation or expected requirement for mechanical ventilation within the next 12 hours

Sites / Locations

  • Emory UniversityRecruiting
  • Northwestern UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

OLE Therapy with The MetaNeb® System

Control Group

Arm Description

Subjects in the active treatment group will receive OLE therapy with The MetaNeb® System following the labeled instructions for the device.

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.

Outcomes

Primary Outcome Measures

Hospital Length of Stay
Number of days/hours the patient is in the hospital after initiation of high-flow oxygen therapy

Secondary Outcome Measures

Full Information

First Posted
October 6, 2020
Last Updated
May 4, 2022
Sponsor
Hill-Rom
Collaborators
Emory University, Northwestern University
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1. Study Identification

Unique Protocol Identification Number
NCT04582214
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 28, 2020 (Actual)
Primary Completion Date
April 30, 2022 (Anticipated)
Study Completion Date
June 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hill-Rom
Collaborators
Emory University, Northwestern University

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

Brief Summary
A Pilot Study of the Use of Oscillation and Lung Expansion (OLE) Therapy in Patients Hospitalized with COVID-19
Detailed Description
This is a randomized prospective open-label cohort study in patients with COVID-19 to evaluate the impact of Oscillation and Lung Expansion (OLE) therapy using The MetaNeb® System on the hospital length of stay in patients hospitalized and receiving heated high-flow oxygen therapy for COVID-19 infection. The active treatment group will consist of patients who are treated OLE therapy while on heated high-flow oxygen therapy . Results from subjects in the active treatment group will be compared to results from patients treated with standard care with no OLE therapy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19, Oscillation and Lung Expansion

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The active treatment group will consist of patients who are treated OLE therapy while on heated high-flow oxygen therapy. 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)
Allocation
Randomized
Enrollment
6 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
OLE Therapy with The MetaNeb® System
Arm Type
Experimental
Arm Description
Subjects in the active treatment group will receive OLE therapy with The MetaNeb® System following the labeled instructions for the device.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
MetaNeb® System
Intervention Description
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.
Primary Outcome Measure Information:
Title
Hospital Length of Stay
Description
Number of days/hours the patient is in the hospital after initiation of high-flow oxygen therapy
Time Frame
Time frame begins when the patient is first started on heated high-flow oxygen therapy and ends when they are ready for discharge from the hospital. Expected time is a a few days but not expected to exceed 3 weeks.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adult patient (> 18 years of age) Tested positive or person under investigation (PUI) for COVID-19 infection Currently require heated high-flow oxygen therapy to maintain SaO2 > 90 % Signed informed consent (phone consent) Heated high-flow oxygen initiated within the past 72 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 Current requirement for mechanical ventilation or expected requirement for mechanical ventilation within the next 12 hours
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Brian Becker, RT
Phone
612.600.1301
Email
brian.becker@hillrom.com
First Name & Middle Initial & Last Name or Official Title & Degree
Lindsay Downing, MPH
Phone
804.307.0924
Email
lindsay.downing@hillrom.com
Facility Information:
Facility Name
Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elizabeth Cox
Email
elizabeth.m.cox@emory.edu
First Name & Middle Initial & Last Name & Degree
Colin Swenson, MD
Facility Name
Northwestern University
City
Evanston
State/Province
Illinois
ZIP/Postal Code
60208
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Phill Cooper
Phone
312-503-0406
Email
p-cooper@northwestern.edu
First Name & Middle Initial & Last Name & Degree
Lisa Wolfe, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Oscillation and Lung Expansion Therapy in Patients With COVID-19

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