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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 : May 10, 2022
Sponsor:
Collaborators:
Emory University
Northwestern University
Information provided by (Responsible Party):
Hill-Rom

Tracking Information
First Submitted Date  ICMJE October 6, 2020
First Posted Date  ICMJE October 9, 2020
Last Update Posted Date May 10, 2022
Actual Study Start Date  ICMJE September 28, 2020
Estimated Primary Completion Date April 30, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 4, 2022)
Hospital Length of Stay [ 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. ]
Number of days/hours the patient is in the hospital after initiation of high-flow oxygen therapy
Original Primary Outcome Measures  ICMJE
 (submitted: October 8, 2020)
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
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Oscillation and Lung Expansion Therapy in Patients With COVID-19
Official Title  ICMJE A Pilot Study of the Use of Oscillation and Lung Expansion (OLE) Therapy in Patients Hospitalized With COVID-19
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Primary Purpose: Treatment
Condition  ICMJE
  • COVID-19
  • Oscillation and Lung Expansion
Intervention  ICMJE 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.
Study Arms  ICMJE
  • 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.
    Intervention: Device: MetaNeb® System
  • 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.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 4, 2022)
6
Original Estimated Enrollment  ICMJE
 (submitted: October 8, 2020)
30
Estimated Study Completion Date  ICMJE June 30, 2022
Estimated Primary Completion Date April 30, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Brian Becker, RT 612.600.1301 brian.becker@hillrom.com
Contact: Lindsay Downing, MPH 804.307.0924 lindsay.downing@hillrom.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04582214
Other Study ID Numbers  ICMJE CR-RR-2020-002
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Hill-Rom
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Hill-Rom
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE
  • Emory University
  • Northwestern University
Investigators  ICMJE Not Provided
PRS Account Hill-Rom
Verification Date May 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP