Evaluating lung therapies for patients after heart surgery
Official title: Hyperinflation Respiratory Therapies in Cardiac Surgery Patients: A Randomized, Observer-Blinded, Prospective Clinical Trial
Run by University of Texas Southwestern Medical Center · NCT04164173 · Data updated 2026-11-12
This study tests three different breathing therapies to see which one helps patients recover their lung function best after heart surgery.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 80 Years |
| Sex | All |
| Enrollment | 324 (estimated) |
| Sponsor | University of Texas Southwestern Medical Center Academic / other |
| Locations | 1 site (Dallas, Texas) |
| Status | Recruiting |
| Started | June 15, 2020 |
| Main results expected | August 1, 2028 |
| Study ends | December 31, 2028 |
| Registry record updated | November 4, 2025 |
| Trial ID | NCT04164173 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 and older who have undergone cardiac surgery via median sternotomy and are admitted to the Cardiovascular ICU.
✕Probably not a fit
Patients with a BMI over 40, those who refuse consent, or individuals with prior or current lung transplants may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial aims to assess the effectiveness of three different hyperinflation respiratory therapies—Intermittent Positive Pressure Breathing (IPPB), Intermittent positive end expiratory pressure (EzPAP), and Metaneb—in improving lung recovery in patients following cardiac surgery. Participants will be randomly assigned to one of the therapies to determine which method enhances lung expansion and reduces postoperative respiratory complications. The study focuses on patients recovering from procedures such as coronary artery bypass grafting and valve repairs, where lung expansion is critical to prevent issues like atelectasis.
Why it matters
Potential benefit: If successful, this study could lead to improved lung recovery and reduced respiratory complications for cardiac surgery patients.
How similar studies have gone: Previous studies have shown mixed results regarding the effectiveness of various respiratory therapies, making this approach both relevant and necessary for further exploration.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
UT Southwestern Clements University Hospital
Dallas, Texas, United States Recruiting
Study contacts
- Study coordinator: Jaffer Odeh, MD
- Email: Jaffer.Odeh@UTSouthwestern.edu
- Phone: 214-786-1067
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.