Evaluation of The MetaNeb® System to Reduce Postoperative Pulmonary Complications

NCT02627742 | Completed Results

• 1 other identifier: CR-RR2015-001
• Study Type: interventional
• Target: 419
• Locations: 1 country
• Sites: 3

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.

Conditions

Atelectasis; Pulmonary Complications

Outcome Measures

Primary Outcomes (1)

• Significant Postoperative Pulmonary Complication Incidence.

  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

  Within seven (7) days of the post-surgical admission

Secondary Outcomes (7)

• 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)

• 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)

• Length of ICU Stay During Initial Hospital Stay

  Total days/hours until time of discharge from the hospital, up to 8 weeks

• Length of Hospital Stay During Initial Hospital Stay

  Time of admission until time of discharge from the hospital, up to 8 weeks

• Readmission to ICU and Transfers to Elevated Level of Care for Pulmonary Complications During Initial Hospital Stay

  during hospital stay, up to 8 weeks

Study Arms (1)

METANEB

EXPERIMENTAL

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

Device: MetaNeb® System

Interventions

MetaNeb® System DEVICE

The treatment protocol used for Respiratory Care during the CHANGE IN PRACTICE period of the Study will be that prescribed by the patient's health care team in the routine standard care of each patient. With the exception of standard airway clearance and lung expansion procedures, other components of the patients respiratory care regimen will remain the same as during the standard therapy period, however the CHANGE IN PRACTICE will incorporate the use/treatment with The MetaNeb® System as an alternative to usual airway clearance and lung expansion procedures. Use of The MetaNeb® System will follow the labeling of the device.

METANEB

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Hill-Rom: lead

Study Sites (3)

Lahey Hospital and Medical Center

Burlington, Massachusetts, 01805, United States

Location

Carolinas Medical Center

Charlotte, North Carolina, 28203, United States

Location

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (2)

• Huynh TT. et al.,

  BACKGROUND

• 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.

  PMID: 31362061 DERIVED

MeSH Terms

Conditions

Pulmonary Atelectasis

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Baxter Clinical Trials Disclosure Call Center
• Organization: Baxter Healthcare

Global_CORP_ClinicalTrialsDisclosure@baxter.com

(224) 948-7359

Study Officials

• Timothy Liesching, MD, FCCP

  Lahey Hospital & Medical Center

  PRINCIPAL INVESTIGATOR

• Maurizio Cereda, MD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

• Toan Huynh, MD FACS FCCM

  Carolinas Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2015
• First Posted: December 11, 2015
• Study Start: March 1, 2016
• Primary Completion: August 1, 2017
• Study Completion: August 1, 2017
• Last Updated: January 29, 2024
• Results First Posted: January 29, 2024

Record last verified: 2024-01

Locations

US (3)