Evaluation of The MetaNeb® System to Reduce Postoperative Pulmonary Complications

Study Overview
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Brief Summary
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To determine if a therapy regimen including treatment with The MetaNeb® System has a positive impact on the rate of pulmonary complications that occur in high risk post-operative patients. This is a non-randomized facility (or hospital) level pre-post intervention study.

Detailed Description
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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 will 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 will be performed. In Stage II, a CHANGE IN PRACTICE will be made and patients will receive standard care with the addition of therapy with The MetaNeb® System. Demographic, clinical & outcome data will be collected for eligible patients during the two stages of the study. Study staff will collect data from the medical records, following a protocol determined schedule.

Official Title
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Evaluation of a Practice Change to Include The MetaNeb® System to Reduce Postoperative Pulmonary Complications

Conditions
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Atelectasis, Pulmonary Complications

Intervention / Treatment
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* Device: MetaNeb® System


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: METANEB<br>Patients will receive standard care with the addition of therapy with The MetaNeb® System. | Device: MetaNeb® System<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Significant Postoperative Pulmonary Complication Incidence | Patient Requires Prolonged Mechanical Ventilation, Patient requires prolonged respiratory support for > 24 hours post-surgery, Diagnosis of Pneumonia Within Seven (7) Days, Readmission to ICU (or transfer to an elevated level of care) for pulmonary complications within seven (7) days of discharge | Occurs within seven (7) days of the post-surgical admission will be considered a Significant Postoperative Pulmonary Complication | 

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 |  | from the time of the post-surgical admission to the hospital unit until discharge from the hospital, up to 8 weeks | 
| Requirement for respiratory support > 48 hours within seven (7) days of the post-surgical hospital admission |  | from the time of the post-surgical admission to the hospital unit until time of discharge from the hospital, up to 8 weeks | 
| Length of ICU stay during initial hospital stay |  | Total days/hours until time of discharge from the hospital, up to 8 weeks | 
| Length of hospital stay during initial hospital stay |  | 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 |  | during hospital stay, up to 8 weeks | 
| Readmission to hospital |  | 30 days following discharge from the hospital | 
| Time on Mechanical Ventilation |  | 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 |