Evaluation of The MetaNeb® System to Reduce Postoperative Pulmonary Complications

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.

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)