Oscillation and Lung Expansion Therapy in Patients With COVID-19

Hill-Rom

Status: Unknown

Conditions: COVID-19; Oscillation and Lung Expansion

Treatments: Device: MetaNeb® System

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04582214

CR-RR-2020-002

Details and patient eligibility

About

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

Full 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.

Enrollment: 6 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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6 participants in 2 patient groups

OLE Therapy with The MetaNeb® System

Experimental group

Description:

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

Treatment:

Device: MetaNeb® System

Control Group

No Intervention group

Description:

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.