Oscillation and Lung Expansion Therapy in Patients With COVID-19

COVID-19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04582214
• Other study ID #: CR-RR-2020-002
• Status: Recruiting
• Phase: N/A
• Start date: September 28, 2020
• Est. completion date: June 30, 2022

Study information

• Verified date: May 2022
• Source: Hill-Rom
• Contact: Brian Becker, RT
• Phone: 612.600.1301
• Email: brian.becker[@]hillrom.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 6
• Est. completion date: June 30, 2022
• Est. primary completion date: April 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Oscillation and Lung Expansion

Intervention

Device:
• 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.

Locations

Country	Name	City	State
United States	Emory University	Atlanta	Georgia
United States	Northwestern University	Evanston	Illinois

Sponsors (3)

Lead Sponsor	Collaborator
Hill-Rom	Emory University, Northwestern University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hospital Length of Stay	Number of days/hours the patient is in the hospital after initiation of high-flow oxygen therapy	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.