Oscillation and Lung Expansion Therapy in Patients With COVID-19

Study Overview
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Brief Summary
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A Pilot Study of the Use of Oscillation and Lung Expansion (OLE) Therapy in Patients Hospitalized with COVID-19

Detailed Description
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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.

Official Title
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A Pilot Study of the Use of Oscillation and Lung Expansion (OLE) Therapy in Patients Hospitalized With COVID-19

Conditions
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COVID-19, Oscillation and Lung Expansion

Intervention / Treatment
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* Device: MetaNeb® System


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: OLE Therapy with The MetaNeb® System<br>Subjects in the active treatment group will receive OLE therapy with The MetaNeb® System following the labeled instructions for the device. | Device: MetaNeb® System<br>* 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.<br>|
| No Intervention: Control Group<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |