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Oscillation and Lung Expansion Therapy in Patients With COVID-19

H

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)

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.

Trial contacts and locations

2

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Central trial contact

Brian Becker, RT; Lindsay Downing, MPH

Data sourced from clinicaltrials.gov

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