Oscillation and Lung Expansion Therapy in Patients With COVID-19
NCT ID: NCT04582214
Last Updated: 2022-05-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
6 participants
INTERVENTIONAL
2020-09-28
2022-06-30
Brief Summary
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Detailed Description
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Results from subjects in the active treatment group will be compared to results from patients treated with standard care with no OLE therapy.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
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.
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.
No interventions assigned to this group
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Emory University
OTHER
Northwestern University
OTHER
Hill-Rom
INDUSTRY
Responsible Party
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Locations
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Emory University
Atlanta, Georgia, United States
Northwestern University
Evanston, Illinois, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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CR-RR-2020-002
Identifier Type: -
Identifier Source: org_study_id
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