Evaluating lung therapies for patients after heart surgery
Hyperinflation Respiratory Therapies in Cardiac Surgery Patients: A Randomized, Observer-Blinded, Prospective Clinical Trial
This study tests three different breathing therapies to see which one helps patients recover their lung function best after heart surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 324 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | University of Texas Southwestern Medical Center Academic / other |
| Locations | 1 site (Dallas, Texas) |
| Trial ID | NCT04164173 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: Previous studies have shown mixed results regarding the effectiveness of various respiratory therapies, making this approach both relevant and necessary for further exploration.
Eligibility criteria
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 this trial is running
Dallas, Texas
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.