MedTrace Logo

Evaluation of The MetaNeb® System to Reduce Postoperative Pulmonary Complications

NCT02627742 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 419

Last updated 2024-01-29

Study results available
· View outcomes & findings →

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

Interventions

DEVICE

MetaNeb® System

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.

Sponsors & Collaborators

  • Hill-Rom

    lead INDUSTRY

Principal Investigators

  • Timothy Liesching, MD, FCCP · Lahey Hospital & Medical Center

  • Maurizio Cereda, MD · University of Pennsylvania

  • Toan Huynh, MD FACS FCCM · Carolinas Medical Center

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-03-31
Primary Completion
2017-08-31
Completion
2017-08-31

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02627742 on ClinicalTrials.gov