Oscillation and Lung Expansion Therapy in Patients With COVID-19
A Pilot Study of the Use of Oscillation and Lung Expansion (OLE) Therapy in Patients Hospitalized With COVID-19
1 other identifier
interventional
6
1 country
2
Brief Summary
A Pilot Study of the Use of Oscillation and Lung Expansion (OLE) Therapy in Patients Hospitalized with COVID-19
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable covid19
Started Sep 2020
Longer than P75 for not_applicable covid19
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 28, 2020
CompletedFirst Submitted
Initial submission to the registry
October 6, 2020
CompletedFirst Posted
Study publicly available on registry
October 9, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2022
CompletedMay 10, 2022
May 1, 2022
1.6 years
October 6, 2020
May 4, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Hospital Length of Stay
Number of days/hours the patient is in the hospital after initiation of high-flow oxygen therapy
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.
Study Arms (2)
OLE Therapy with The MetaNeb® System
EXPERIMENTALSubjects in the active treatment group will receive OLE therapy with The MetaNeb® System following the labeled instructions for the device.
Control Group
NO INTERVENTIONThe 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Hill-Romlead
- Emory Universitycollaborator
- Northwestern Universitycollaborator
Study Sites (2)
Emory University
Atlanta, Georgia, 30322, United States
Northwestern University
Evanston, Illinois, 60208, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 6, 2020
First Posted
October 9, 2020
Study Start
September 28, 2020
Primary Completion
April 30, 2022
Study Completion
June 30, 2022
Last Updated
May 10, 2022
Record last verified: 2022-05
Data Sharing
- IPD Sharing
- Will not share