COVID-19NCT04582214
Oscillation and Lung Expansion Therapy in Patients With COVID-19
A study testing MetaNeb® System in people with COVID-19 and Oscillation and Lung Expansion, run by Hill-Rom at 2 sites in United States.
Trial summary
A Pilot Study of the Use of Oscillation and Lung Expansion (OLE) Therapy in Patients Hospitalized with COVID-19 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19, Oscillation and Lung Expansion
- What is being tested?
- MetaNeb® System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 2 sitesUnited States
- Study dates
- 28 Sep 2020to 30 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
2 sites in 1 country.
United States2 sites, 2 recruiting
- Recruiting
Emory University
Atlanta, Georgia, 30322
Elizabeth Cox, elizabeth.m.cox@emory.edu
Colin Swenson, MD
- Recruiting
Northwestern University
Evanston, Illinois, 60208
Phill Cooper, 312-503-0406, p-cooper@northwestern.edu
Lisa Wolfe, MD
About this study
Official title: A Pilot Study of the Use of Oscillation and Lung Expansion (OLE) Therapy in Patients Hospitalized With COVID-19
A Pilot Study of the Use of Oscillation and Lung Expansion (OLE) Therapy in Patients Hospitalized with COVID-19
Read the 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.
- Conditions
- COVID-19, Oscillation and Lung Expansion
- Being tested
- MetaNeb® System
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MetaNeb® SystemDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| OLE Therapy with The MetaNeb® System | Experimental | Subjects in the active treatment group will receive OLE therapy with The MetaNeb® System following the labeled instructions for the device. Receives: Device: MetaNeb® System |
| Control Group | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospital Length of Stay
Number of days/hours the patient is in the hospital after initiation of high-flow oxygen therapy
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2020
- Study start28 Sep 2020
- Primary completion30 Apr 2022 (estimated)
- Study completion30 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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 retrospectively collected results from patients treated with standard care with no OLE therapy.
- Masking
- None (open label)
- Enrolment
- 6 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hill-Rom
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Emory University, Northwestern University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04582214
- Sponsor's protocol ID
- CR-RR-2020-002
- Status last verified
- May 2022
- First submitted
- 6 Oct 2020
- Last updated
- 10 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of the Use of Oscillation and Lung Expansion (OLE) Therapy in Patients Hospitalized With COVID-19
- ClinicalTrials.gov ID
- NCT04582214
- Acronym / sponsor ID
- CR-RR-2020-002
- Conditions
- COVID-19, Oscillation and Lung Expansion
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 6 participants (estimated)
- Lead sponsor
- Hill-RomIndustry (pharma, biotech, devices)
- Collaborators
- Emory University, Northwestern University
- Study start
- 28 Sep 2020 (actual)
- Primary completion
- 30 Apr 2022 (estimated)
- Study completion
- 30 Jun 2022 (estimated)
- First posted
- 9 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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 retrospectively collected results from patients treated with standard care with no OLE therapy.
| Arm | Type | Receives |
|---|---|---|
| OLE Therapy with The MetaNeb® System | Experimental | Device: MetaNeb® SystemSubjects in the active treatment group will receive OLE therapy with The MetaNeb® System following the labeled instructions for the device. |
| Control Group | No intervention | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MetaNeb® SystemThe 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. | Device | OLE Therapy with The MetaNeb® System |
Primary outcome
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.
Number of days/hours the patient is in the hospital after initiation of high-flow oxygen therapy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MetaNeb® System in people with COVID-19 and Oscillation and Lung Expansion, run by Hill-Rom at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Brian Becker, RT (612.600.1301, brian.becker@hillrom.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2022.