Oscillation and Lung Expansion Therapy in Patients With COVID-19

Not Applicable

• Conditions: Oscillation and Lung Expansion; COVID-19
• Interventions: Device: MetaNeb® System

• Registration Number: NCT04582214
• Lead Sponsor: Hill-Rom

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.

Study Timeline

• Study Start: 2020-09-28
• Study First Submitted: 2020-10-06
• Study First Submitted QC: 2020-10-08
• Study First Posted: 2020-10-09
• Primary Completion: 2022-04-30
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-04
• Last Update Posted: 2022-05-10
• Study Completion: 2022-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 6

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
OLE Therapy with The MetaNeb® System	MetaNeb® System	Subjects in the active treatment group will receive OLE therapy with The MetaNeb® System following the labeled instructions for the device.

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

Emory University; 🇺🇸 Atlanta, Georgia, United States

Northwestern University; 🇺🇸 Evanston, Illinois, United States