Evaluation of The MetaNeb® System to Reduce Postoperative Pulmonary Complications

Hill-Rom

Status: Completed

Conditions: Atelectasis; Pulmonary Complications

Treatments: Device: MetaNeb® System

Study type: Interventional

Funder types: Industry

Identifiers

NCT02627742

CR-RR2015-001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 419 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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419 participants in 1 patient group

METANEB

Experimental group

Description:

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

Treatment:

Device: MetaNeb® System