A Pilot Study of the Use of Oscillation and Lung Expansion (OLE) Therapy in Patients Hospitalized with COVID-19
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.
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.
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
Emory University
Atlanta, Georgia, United States
Northwestern University
Evanston, Illinois, United States
Brian Becker, RT
612.600.1301
brian.becker@hillrom.com
Lindsay Downing, MPH
804.307.0924
lindsay.downing@hillrom.com