Recruiting

Lung Expansion Therapy

Sponsor:

Hill-Rom

Code:

NCT04582214

Conditions

COVID-19

Oscillation and Lung Expansion

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

MetaNeb® System

Study Details

Brief summary:

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

Conditions

COVID-19

Oscillation and Lung Expansion

Study ID

NCT04582214

Start date

Sep 28, 2020

Status verified date

May, 2022

Completion date

Jun 30, 2022

Anticipated

Primary completion date

Apr 30, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

6 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: OLE Therapy with The MetaNeb® System

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

no intervention: Control Group

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.

Interventions

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.

Primary outcome measure

  • Hospital Length of Stay [ 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 and Locations

Central contacts

Brian Becker, RT

612.600.1301brian.becker@hillrom.com

Lindsay Downing, MPH

804.307.0924lindsay.downing@hillrom.com

Locations

Emory University

Recruiting

Atlanta, Georgia, United States, 30322

Contacts

Elizabeth Cox

elizabeth.m.cox@emory.edu

Principal Investigator:

Colin Swenson, MD

Northwestern University

Recruiting

Evanston, Illinois, United States, 60208

Contacts

Phill Cooper

312-503-0406p-cooper@northwestern.edu

Principal Investigator:

Lisa Wolfe, MD

More Information

Sponsor

Hill-Rom

Last update posted

May 10, 2022

Last verified

May, 2022

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Hill-Rom on 2022-05-10.