Clinical trial NCT02627742: Evaluation of The MetaNeb® System to Reduce Postoperative Pulmonary Complications
Official title: Evaluation of a Practice Change to Include The MetaNeb® System to Reduce Postoperative Pulmonary Complications
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atelectasis
Pulmonary Complications
Lead sponsor: Baxter Healthcare Corporation
Sponsor class: INDUSTRY
First posted: 2015-12-11
Enrollment: 419
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: 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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Significant Postoperative Pulmonary Complication Incidence.
timeFrame: Within seven (7) days of the post-surgical admission
Secondary outcomes:
measure: Requirement for Invasive Mechanical Ventilation for > 48 Hours Within Seven (7) Days of the Post-surgical Hospital Admission
timeFrame: 7 days (From the time of post-surgical admission to the hospital through day 7 following the initial post-surgical admission)
measure: Requirement for Respiratory Support > 48 Hours Within Seven (7) Days of the Post-surgical Hospital Admission
timeFrame: 7 days (From the time of post-surgical admission to the hospital through day 7 following the initial post-surgical admission)
measure: Length of ICU Stay During Initial Hospital Stay
timeFrame: Total days/hours until time of discharge from the hospital, up to 8 weeks
measure: Length of Hospital Stay During Initial Hospital Stay
timeFrame: Time of admission until time of discharge from the hospital, up to 8 weeks
measure: Readmission to ICU and Transfers to Elevated Level of Care for Pulmonary Complications During Initial Hospital Stay
timeFrame: during hospital stay, up to 8 weeks
measure: Readmission to Hospital
timeFrame: 30 days following discharge from the hospital
measure: Time on Mechanical Ventilation
timeFrame: 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
Other outcomes:
Locations:
city: Burlington
country: United States
facility: Lahey Hospital and Medical Center
state: Massachusetts
city: Charlotte
country: United States
facility: Carolinas Medical Center
state: North Carolina
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: Lahey Hospital & Medical Center
name: Timothy Liesching, MD, FCCP
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Pennsylvania
name: Maurizio Cereda, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Carolinas Medical Center
name: Toan Huynh, MD FACS FCCM
role: PRINCIPAL_INVESTIGATOR
References:
citation: Huynh TT. et al.,
citation: Huynh TT, Liesching TN, Cereda M, Lei Y, Frazer MJ, Nahouraii MR, Diette GB. Efficacy of Oscillation and Lung Expansion in Reducing Postoperative Pulmonary Complication. J Am Coll Surg. 2019 Nov;229(5):458-466.e1. doi: 10.1016/j.jamcollsurg.2019.06.004. Epub 2019 Jul 27.