- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02627742
Evaluation of The MetaNeb® System to Reduce Postoperative Pulmonary Complications
Evaluation of a Practice Change to Include The MetaNeb® System to Reduce Postoperative Pulmonary Complications
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Massachusetts
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Burlington, Massachusetts, United States, 01805
- Lahey Hospital and Medical Center
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North Carolina
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Charlotte, North Carolina, United States, 28203
- Carolinas Medical Center
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19104
- Hospital of the University of Pennsylvania
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
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
Exclusion Criteria:
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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: METANEB
Patients will receive standard care with the addition of therapy with The MetaNeb® System.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Significant Postoperative Pulmonary Complication Incidence.
Time Frame: Within seven (7) days of the post-surgical admission
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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)
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Within seven (7) days of the post-surgical admission
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
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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.
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7 days (From the time of post-surgical admission to the hospital through day 7 following the initial post-surgical admission)
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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)
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Respiratory support greater than the patient's baseline level for a period longer than 48 hours
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7 days (From the time of post-surgical admission to the hospital through day 7 following the initial post-surgical admission)
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Length of ICU Stay During Initial Hospital Stay
Time Frame: Total days/hours until time of discharge from the hospital, up to 8 weeks
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ICU length of stay, during initial hospital stay, was determined by calculating the number of days/hours spent in ICU. The following was documented:
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Total days/hours until time of discharge from the hospital, up to 8 weeks
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Length of Hospital Stay During Initial Hospital Stay
Time Frame: Time of admission until time of discharge from the hospital, up to 8 weeks
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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) |
Time of admission until time of discharge from the hospital, up to 8 weeks
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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
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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:
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during hospital stay, up to 8 weeks
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Readmission to Hospital
Time Frame: 30 days following discharge from the hospital
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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.
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30 days following discharge from the hospital
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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
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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
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Timothy Liesching, MD, FCCP, Lahey Hospital & Medical Center
- Principal Investigator: Maurizio Cereda, MD, University of Pennsylvania
- Principal Investigator: Toan Huynh, MD FACS FCCM, Carolinas Medical Center
Publications and helpful links
General Publications
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CR-RR2015-001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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