N/A N=419 Prevention

Evaluation of The MetaNeb® System to Reduce Postoperative Pulmonary Complications

Atelectasis · Pulmonary Complications

Bottom Line

View on ClinicalTrials.gov: NCT02627742 ↗

Enrolled (actual)

419

Serious AEs

4.1%

Results posted

Jan 2024

Primary outcome: Primary: Significant Postoperative Pulmonary Complication Incidence. — 48; 33; 162; 176 Participants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: MetaNeb® System (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Hill-Rom
Primary completion: Aug 2017

Outcome Measures

Outcome	Result	p-value
PRIMARY Significant Postoperative Pulmonary Complication Incidence.	48; 33; 162; 176	—
SECONDARY Requirement for Invasive Mechanical Ventilation for > 48 Hours Within Seven (7) Days of the Post-surgical Hospital Admission	19; 14	—
SECONDARY Requirement for Respiratory Support > 48 Hours Within Seven (7) Days of the Post-surgical Hospital Admission	21; 19	—
SECONDARY Length of ICU Stay During Initial Hospital Stay	2.11; 1.27	—
SECONDARY Length of Hospital Stay During Initial Hospital Stay	8.40; 6.78	—
SECONDARY Readmission to ICU and Transfers to Elevated Level of Care for Pulmonary Complications During Initial Hospital Stay	205; 204; 5; 4; 0; 1	—
SECONDARY Readmission to Hospital	36; 28	—
SECONDARY Time on Mechanical Ventilation	18.57; 7.64; 23.7; 8.5; 0.5; 0.6	—

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.

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)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02627742). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.