Oscillation and Lung Expansion Therapy in Patients With COVID-19
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|ClinicalTrials.gov Identifier: NCT04582214|
Recruitment Status : Recruiting
First Posted : October 9, 2020
Last Update Posted : May 10, 2022
|Condition or disease||Intervention/treatment||Phase|
|COVID-19 Oscillation and Lung Expansion||Device: MetaNeb® System||Not Applicable|
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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||6 participants|
|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)|
|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 :||April 30, 2022|
|Estimated Study Completion Date :||June 30, 2022|
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.
- 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
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
|Contact: Brian Becker, RTfirstname.lastname@example.org|
|Contact: Lindsay Downing, MPHemail@example.com|
|United States, Georgia|
|Atlanta, Georgia, United States, 30322|
|Contact: Elizabeth Cox firstname.lastname@example.org|
|Principal Investigator: Colin Swenson, MD|
|United States, Illinois|
|Evanston, Illinois, United States, 60208|
|Contact: Phill Cooper 312-503-0406 email@example.com|
|Principal Investigator: Lisa Wolfe, MD|