Evaluation of The MetaNeb® System to Reduce Postoperative Pulmonary Complications

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

419 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-31

Study Completion Date

2017-08-31

Brief Summary

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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.

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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 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

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Atelectasis Pulmonary Complications

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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METANEB

Patients will receive standard care with the addition of therapy with The MetaNeb® System.

Group Type EXPERIMENTAL

MetaNeb® System

Intervention Type DEVICE

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.

Interventions

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MetaNeb® System

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.

Intervention Type DEVICE

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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No