Evaluation of a Practice Change to Include The MetaNeb® System to Reduce Postoperative Pulmonary Complications
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 419
- Locations
- 6
- Primary Endpoint
- Significant Postoperative Pulmonary Complication Incidence.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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)
Outcomes
Primary Outcomes
Significant Postoperative Pulmonary Complication Incidence.
Time Frame: Within seven (7) days of the post-surgical admission
One or more of the following that occurs within seven (7) days of the post-surgical admission will be considered a Significant Postoperative Pulmonary Complication (PPC) * Patient requires prolonged mechanical ventilation (\> 24 hours from post-surgical admission) * Patient requires prolonged respiratory support for \> 24 hours from post-surgical admission * Diagnosis of pneumonia within seven (7) days * Readmission to ICU for pulmonary complications within seven (7) days of post-surgical hospital admission
Secondary Outcomes
- Requirement for Invasive Mechanical Ventilation for > 48 Hours Within Seven (7) Days of the Post-surgical Hospital Admission(7 days (From the time of post-surgical admission to the hospital through day 7 following the initial post-surgical admission))
- Length of Hospital Stay During Initial Hospital Stay(Time of admission until time of discharge from the hospital, up to 8 weeks)
- Requirement for Respiratory Support > 48 Hours Within Seven (7) Days of the Post-surgical Hospital Admission(7 days (From the time of post-surgical admission to the hospital through day 7 following the initial post-surgical admission))
- 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)
- Length of ICU Stay During Initial Hospital Stay(Total days/hours until time of discharge from the hospital, up to 8 weeks)
- Readmission to Hospital(30 days following discharge from the hospital)
- Readmission to ICU and Transfers to Elevated Level of Care for Pulmonary Complications During Initial Hospital Stay(during hospital stay, up to 8 weeks)