AtelectasisNCT02627742
Evaluation of The MetaNeb® System to Reduce Postoperative Pulmonary Complications
A study testing MetaNeb® System in people with Atelectasis and Pulmonary Complications, run by Hill-Rom at 3 sites in United States.
Trial summary
To determine if a therapy regimen including treatment with The MetaNeb® System had a positive impact on the rate of pulmonary complications related to atelectasis and/or secretion retention that occur in high risk post-operative patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atelectasis, Pulmonary Complications
- 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
- 419 participants
- Where
- 3 sitesUnited States
- Study dates
- Mar 2016to Aug 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Age ≥ 18 years Post-thoracic, -upper abdominal or -aortic surgery Open surgical procedure Incision at or above the umbilicus
- High risk defined by:
- Documented ASA class ≥ 3 OR
- Documented ASA class 2 AND One or more of the following:
- Current smoker or smoking history within past 6 months History of COPD Documented obesity and/or BMI ≥ 30 kg/m2 Age ≥ 75
Who cannot join
- Contraindication to Continuous High Frequency Oscillation (CHFO) therapy
- Minimally invasive, or ". . . scopic" procedure.
- Spinal surgery involving a posterior approach.
- Surgery for organ transplant.
- Chronic invasive positive pressure ventilation (PPV)
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Lahey Hospital and Medical Center
Burlington, Massachusetts, 01805
Carolinas Medical Center
Charlotte, North Carolina, 28203
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: Evaluation of a Practice Change to Include The MetaNeb® System to Reduce Postoperative Pulmonary Complications
To determine if a therapy regimen including treatment with The MetaNeb® System had a positive impact on the rate of pulmonary complications related to atelectasis and/or secretion retention that occur in high risk post-operative patients. This is a non-randomized facility (or hospital) level pre-post intervention study.
Read the detailed description
Post-operative pulmonary complications (PPC) are associated with significant excess morbidity, mortality and healthcare expenditure. Although PPCs are an incompletely understood multifactorial syndrome, atelectasis is recognized as a critical component. A variety of strategies have been shown to reduce the risk for development of post-operative atelectasis including lung expansion (LE) therapies. Well-designed studies are needed to distinguish which LE approach has the greatest potential to optimize patient care, clinical outcomes and cost savings.
Intrapulmonary percussive ventilation (IPV) devices have been in use for more than 25 years and are used widely in the acute care, post-surgical, and homecare setting. Such devices provide both LE and airway clearance therapy (ACT) for patients with obstructive and/or restrictive lung diseases and conditions. The MetaNeb® System is an LE expansion modality that incorporates all the physiological effects of IPV while providing additional therapeutic advantages intended primarily to more effectively treat or prevent pulmonary atelectasis.
The study was be conducted in two stages. In Stage I of the study, a retrospective review of medical records for post-surgical patients, who received STANDARD THERAPY as defined by current hospital and respiratory care department policies and procedures was performed. In Stage II, a CHANGE IN PRACTICE was made and patients received standard care with the addition of therapy with The MetaNeb® System. Demographic, clinical \& outcome data was collected for eligible patients during the two stages of the study. Study staff collected data from the medical records, following a protocol determined schedule.
- Conditions
- Atelectasis, Pulmonary Complications
- Being tested
- MetaNeb® System
- Medical subject headings
- Pulmonary Atelectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MetaNeb® SystemDevice
The treatment protocol used for Respiratory Care during the CHANGE IN PRACTICE period of the Study will be that prescribed by the patient's health care team in the routine standard care of each patient. With the exception of standard airway clearance and lung expansion procedures, other components of the patients respiratory care regimen will remain the same as during the standard therapy period, however the CHANGE IN PRACTICE will incorporate the use/treatment with The MetaNeb® System as an alternative to usual airway clearance and lung expansion procedures. Use of The MetaNeb® System will follow the labeling of the device.
| Study group | Role | What they receive |
|---|---|---|
| METANEB | Experimental | Patients will receive standard care with the addition of therapy with The MetaNeb® System. Receives: Device: MetaNeb® System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Significant Postoperative Pulmonary Complication Incidence.
One or more of the following that occurs within seven (7) days of the post-surgical admission will be considered a Significant Postoperative Pulmonary Complication (PPC)
- Patient requires prolonged mechanical ventilation (> 24 hours from post-surgical admission)
- Patient requires prolonged respiratory support for > 24 hours from post-surgical admission
- Diagnosis of pneumonia within seven (7) days
- Readmission to ICU for pulmonary complications within seven (7) days of post-surgical hospital admission
Measured: Within seven (7) days of the post-surgical admission
Secondary outcomes (7)
Requirement for Invasive Mechanical Ventilation for > 48 Hours Within Seven (7) Days of the Post-surgical Hospital Admission
Defined as patient requirement for invasive mechanical ventilation (MV) for > 48 hours (after hour 48) post-operatively. This includes patients that require re-intubation after hour 48, regardless of length of time on MV in the first 48 hours postoperatively.
Measured: 7 days (From the time of post-surgical admission to the hospital through day 7 following the initial post-surgical admission)
Requirement for Respiratory Support > 48 Hours Within Seven (7) Days of the Post-surgical Hospital Admission
Respiratory support greater than the patient's baseline level for a period longer than 48 hours
- Requirement for non-invasive ventilation (NIV) above patient's baseline requirement after hour 48 from post-surgical admission or continuous positive airway pressure (CPAP) above patient's baseline requirement after hour 48.
- Requirement for O2 therapy > 40 % FiO2 or > 5 LPM pm via Nasal Cannula (and above patient's baseline) after hour 48 postoperatively.
Measured: 7 days (From the time of post-surgical admission to the hospital through day 7 following the initial post-surgical admission)
Length of ICU Stay During Initial Hospital Stay
ICU length of stay, during initial hospital stay, was determined by calculating the number of days/hours spent in ICU. The following was documented:
- Time of admission to the ICU to actual time of initial discharge from the ICU during initial hospital stay
- Total ICU days/hours (includes readmissions) during initial hospital stay
Measured: Total days/hours until time of discharge from the hospital, up to 8 weeks
Length of Hospital Stay During Initial Hospital Stay
Hospital length of stay was determined by calculating the number of days/hours spent in hospital. The following was documented:
- Time of admission to time of discharge from the hospital (total days/hours)
Measured: Time of admission until time of discharge from the hospital, up to 8 weeks
Readmission to ICU and Transfers to Elevated Level of Care for Pulmonary Complications During Initial Hospital Stay
Readmissions to ICU and transfers to an elevated level of care, during the initial hospital stay, was documented for each event. The following was documented:
- Number of readmission to ICU or elevated level of care events
- Number of patients requiring readmission to the ICU or to an elevated level of care
Measured: during hospital stay, up to 8 weeks
Readmission to Hospital
Hospital records were reviewed at each site, 30 days after the last patient has been discharged from the hospital. Readmissions, for any cause, within 30 days of discharge for any study patient were documented.
Measured: 30 days following discharge from the hospital
Time on Mechanical Ventilation
- Time to initial extubation from time of initial intubation, if initial intubation was placed after surgery; or from time of post-surgical admission, if intubation was in place prior to start of surgery
- Total time on invasive mechanical ventilation - was determined for each patient by calculating the total number of days/hours intubated and mechanically ventilated from the time of post-surgical admission until the time of initial hospital discharge.
- Total time on non-invasive ventilation - was determined for each patient by calculating the total number of days/hours ordered for non-invasive ventilation from the time of post-surgical admission to the hospital unit until the time of initial hospital discharge.
Measured: total hours/days from the time of the post-surgical admission to the hospital unit until time of discharge from the hospital, up to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2015 (estimated)
- Study startMar 2016
- Primary completionAug 2017
- Study completionAug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for AtelectasisStudies 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 419 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hill-Rom
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Timothy Liesching, MD, FCCP, Principal investigator, Lahey Hospital & Medical CenterMaurizio Cereda, MD, Principal investigator, University of PennsylvaniaToan Huynh, MD FACS FCCM, Principal investigator, Carolinas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02627742
- Sponsor's protocol ID
- CR-RR2015-001
- Status last verified
- Jan 2024
- First submitted
- 2 Dec 2015
- Last updated
- 29 Jan 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Huynh TT. et al.,
Huynh TT, Liesching TN, Cereda M, Lei Y, Frazer MJ, Nahouraii MR, Diette GB. Efficacy of Oscillation and Lung Expansion in Reducing Postoperative Pulmonary Complication. J Am Coll Surg. 2019 Nov;229(5):458-466.e1. doi: 10.1016/j.jamcollsurg.2019.06.004. Epub 2019 Jul 27.
PubMed 31362061
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Practice Change to Include The MetaNeb® System to Reduce Postoperative Pulmonary Complications
- ClinicalTrials.gov ID
- NCT02627742
- Acronym / sponsor ID
- CR-RR2015-001
- Conditions
- Atelectasis, Pulmonary Complications
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 419 participants (actual)
- Lead sponsor
- Hill-RomIndustry (pharma, biotech, devices)
- Study start
- Mar 2016 (actual)
- Primary completion
- Aug 2017 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 11 Dec 2015 (estimated)
- Results
- Posted 29 Jan 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To determine if a therapy regimen including treatment with The MetaNeb® System had a positive impact on the rate of pulmonary complications related to atelectasis and/or secretion retention that occur in high risk post-operative patients. This is a non-randomized facility (or hospital) level pre-post intervention study.
Detailed description
Post-operative pulmonary complications (PPC) are associated with significant excess morbidity, mortality and healthcare expenditure. Although PPCs are an incompletely understood multifactorial syndrome, atelectasis is recognized as a critical component. A variety of strategies have been shown to reduce the risk for development of post-operative atelectasis including lung expansion (LE) therapies. Well-designed studies are needed to distinguish which LE approach has the greatest potential to optimize patient care, clinical outcomes and cost savings.
Intrapulmonary percussive ventilation (IPV) devices have been in use for more than 25 years and are used widely in the acute care, post-surgical, and homecare setting. Such devices provide both LE and airway clearance therapy (ACT) for patients with obstructive and/or restrictive lung diseases and conditions. The MetaNeb® System is an LE expansion modality that incorporates all the physiological effects of IPV while providing additional therapeutic advantages intended primarily to more effectively treat or prevent pulmonary atelectasis.
The study was be conducted in two stages. In Stage I of the study, a retrospective review of medical records for post-surgical patients, who received STANDARD THERAPY as defined by current hospital and respiratory care department policies and procedures was performed. In Stage II, a CHANGE IN PRACTICE was made and patients received standard care with the addition of therapy with The MetaNeb® System. Demographic, clinical \& outcome data was collected for eligible patients during the two stages of the study. Study staff collected data from the medical records, following a protocol determined schedule.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| METANEB | Experimental | Device: MetaNeb® SystemPatients will receive standard care with the addition of therapy with The MetaNeb® System. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥ 18 years Post-thoracic, -upper abdominal or -aortic surgery Open surgical procedure Incision at or above the umbilicus
- Documented ASA class ≥ 3 OR
- Current smoker or smoking history within past 6 months History of COPD Documented obesity and/or BMI ≥ 30 kg/m2 Age ≥ 75
Key exclusion criteria (5 listed)
- Contraindication to Continuous High Frequency Oscillation (CHFO) therapy
- Minimally invasive, or ". . . scopic" procedure.
- Spinal surgery involving a posterior approach.
- Surgery for organ transplant.
- Chronic invasive positive pressure ventilation (PPV)
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 treatment protocol used for Respiratory Care during the CHANGE IN PRACTICE period of the Study will be that prescribed by the patient's health care team in the routine standard care of each patient. With the exception of standard airway clearance and lung expansion procedures, other components of the patients respiratory care regimen will remain the same as during the standard therapy period, however the CHANGE IN PRACTICE will incorporate the use/treatment with The MetaNeb® System as an alternative to usual airway clearance and lung expansion procedures. Use of The MetaNeb® System will follow the labeling of the device. | Device | METANEB |
Primary outcome
Significant Postoperative Pulmonary Complication Incidence.
Time frame: Within seven (7) days of the post-surgical admission
One or more of the following that occurs within seven (7) days of the post-surgical admission will be considered a Significant Postoperative Pulmonary Complication (PPC) * Patient requires prolonged mechanical ventilation (> 24 hours from post-surgical admission) * Patient requires prolonged respiratory support for > 24 hours from post-surgical admission * Diagnosis of pneumonia within seven (7) days * Readmission to ICU for pulmonary complications within seven (7) days of post-surgical hospital admission
7 secondary outcomes
Requirement for Invasive Mechanical Ventilation for > 48 Hours Within Seven (7) Days of the Post-surgical Hospital Admission
Time frame: 7 days (From the time of post-surgical admission to the hospital through day 7 following the initial post-surgical admission)
Requirement for Respiratory Support > 48 Hours Within Seven (7) Days of the Post-surgical Hospital Admission
Time frame: 7 days (From the time of post-surgical admission to the hospital through day 7 following the initial post-surgical admission)
Length of ICU Stay During Initial Hospital Stay
Time frame: Total days/hours until time of discharge from the hospital, up to 8 weeks
Length of Hospital Stay During Initial Hospital Stay
Time frame: Time of admission until time of discharge from the hospital, up to 8 weeks
Readmission to ICU and Transfers to Elevated Level of Care for Pulmonary Complications During Initial Hospital Stay
Time frame: during hospital stay, up to 8 weeks
Readmission to Hospital
Time frame: 30 days following discharge from the hospital
Time on Mechanical Ventilation
Time frame: total hours/days from the time of the post-surgical admission to the hospital unit until time of discharge from the hospital, up to 8 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- BackgroundHuynh TT. et al.,
- Derived from this study: PubMed 31362061Huynh TT, Liesching TN, Cereda M, Lei Y, Frazer MJ, Nahouraii MR, Diette GB. Efficacy of Oscillation and Lung Expansion in Reducing Postoperative Pulmonary Complication. J Am Coll Surg. 2019 Nov;229(5):458-466.e1. doi: 10.1016/j.jamcollsurg.2019.06.004. Epub 2019 Jul 27.
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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.
Timothy Liesching, MD, FCCP principal investigator
Lahey Hospital & Medical Center
Maurizio Cereda, MD principal investigator
University of Pennsylvania
Toan Huynh, MD FACS FCCM principal investigator
Carolinas Medical Center
3 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 Atelectasis and Pulmonary Complications, run by Hill-Rom at 3 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: finished, as of the sponsor's last update on 29 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
Yes. Results are posted in the registry (first posted 29 Jan 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Significant Postoperative Pulmonary Complication Incidence. (time frame: Within seven (7) days of the post-surgical admission). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02627742, which also lists 2 linked publications.
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 29 Jan 2024.