COVID-19, Oscillation and Lung Expansion
Conditions
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.
Interventions
DEVICEMetaNeb® 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.
Sponsors
Emory University
Northwestern University
Hill-Rom
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hospital Length of Stay | 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 |
Countries
United States
Contacts
Primary ContactBrian Becker, RT
Backup ContactLindsay Downing, MPH
Outcome results
None listed