Recruiting

Respiratory Therapies

Sponsor:

University of Texas Southwestern Medical Center

Code:

NCT04164173

Conditions

Pulmonary Disease

Postoperative Complications

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

EzPAP

Metaneb

Intermittent Positive Pressure Breathing (IPPB)

Study Details

Brief summary:

The purpose of this prospective randomized clinical trial is to evaluate three different types of hyperinflation respiratory therapies, Intermittent Positive Pressure Breathing (IPPB), Intermittent positive end expiratory pressure (EzPAP), Metaneb. Investigators will examine which hyperinflation therapy provides better lung expansion and may improve lung recovery after surgery.

Conditions

Pulmonary Disease

Postoperative Complications

Study ID

NCT04164173

Start date

Jun 15, 2020

Status verified date

Oct, 2025

Completion date

Dec 31, 2028

Anticipated

Primary completion date

Aug 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Age 18 years and older
2. Admitted to Cardiovascular ICU (CVICU) after coronary artery bypass grafting (CABG), isolated valve repair/replacement, or CABG + valve repair/replacement
3. Cardiac surgery performed via median sternotomy

Exclusion Criteria:

1. BMI>40
2. Refusal to be consented
3. Prior or current lung transplant patients

Study Design

Enrollment

324 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: EzPAP

The patient will have EzPAP postoperative respiratory therapy as 3 x 10 breaths at a 1:4 ratio four times daily

experimental: Metaneb

The patient will have Metaneb postoperative respiratory therapy as 10 minutes Continuous Positive End Expiratory Pressure (CPEP) four times daily

experimental: Intermittent Positive Pressure Breathing (IPPB)

The patient will have Intermittent positive pressure breathing (IPPB) postoperatively for 10 minutes four times daily

Interventions

EzPAP

Patient will receive 10 min EzPAP 4 times daily

Metaneb

Patient will receive 10 min Metaneb 4 times daily

Intermittent Positive Pressure Breathing (IPPB)

Patient will receive 10 min IPPB 4 times daily

Primary outcome measure

  • Postoperative lung function as assessed by the changes in FEV1/FVC [ Time Frame: Up to 96 hours postoperatively or until discharge from the intensive care unit (ICU), whichever came first. ]

Central Contacts and Locations

Central contacts

Jaffer Odeh, MD

214-786-1067Jaffer.Odeh@UTSouthwestern.edu

Emily Melikman, RN

214-645-7011Emily.Melikman@UTSouthwestern.edu

Locations

UT Southwestern Clements University Hospital

Recruiting

Dallas, Texas, United States, 75390

Contacts

Cheryl Mansir, RT

214/633-4791Cheryl.Mansir@UTSouthwestern.edu

Gabriel Rodriguez, RT

214/633-4791Gabriel.Rodriguez@utsouthwestern.edu

More Information

Sponsor

University of Texas Southwestern Medical Center

Last update posted

Nov 4, 2025

Last verified

Oct, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Texas Southwestern Medical Center on 2025-11-04.