Oscillation and Lung Expansion Therapy in Patients With COVID-19

Hill-Rom6 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

COVID-19 Oscillation and Lung Expansion

Interventions

MetaNeb® SystemDEVICE

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

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (2)

Emory University

Atlanta, Georgia, United States

RECRUITING

Northwestern University

Evanston, Illinois, United States

RECRUITING

Outcomes

Primary Outcomes

Hospital Length of Stay

Number of days/hours the patient is in the hospital after initiation of high-flow oxygen therapy

Time frame: 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.

Central Contacts

Brian Becker, RT

CONTACT

612.600.1301 brian.becker@hillrom.com

Lindsay Downing, MPH

CONTACT

804.307.0924 lindsay.downing@hillrom.com

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.