Actively Recruiting
Hyperinflation Respiratory Therapies in Cardiac Surgery Patients: A Randomized, Observer-Blinded, Prospective Clinical Trial
Led by University of Texas Southwestern Medical Center · Updated on 2025-11-04
324
Participants Needed
1
Research Sites
21 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating three different types of hyperinflation respiratory therapies in patients who have undergone cardiac surgery. The study aims to find out which therapy helps expand the lungs better and may improve lung recovery after surgery. This is important because pain from surgery can limit lung expansion, leading to complications like lung collapse or airway secretion buildup. The trial is a prospective randomized clinical study comparing Intermittent Positive Pressure Breathing (IPPB), Intermittent Positive End Expiratory Pressure (EzPAP), and Metaneb therapies. Participants will be randomly assigned to receive one of the three hyperinflation respiratory therapies. IPPB supports breathing by providing pressure to increase air volume. EzPAP and Metaneb involve breathing against resistance to keep the lungs open longer. Each therapy is given every 4 hours in the intensive care unit, with sessions lasting about 10 to 15 minutes. The total study period lasts about 96 hours after surgery or until the patient is discharged from the ICU. During the study, lung function will be measured daily using a microspirometer, which takes about 5 minutes, to monitor recovery. Researchers will watch for any lung over-expansion risks or typical post-surgery complications, such as pneumothorax, infection, blood changes, or breathing difficulties. The main outcome measured is the change in lung function (FEV1/FVC) up to 96 hours after surgery or until ICU discharge. Participants will be closely monitored throughout their ICU stay for safety and lung recovery progress.
CONDITIONS
Brief Title
Hyperinflation Respiratory Therapies in Cardiac Surgery Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years and older
- Admitted to Cardiovascular ICU after coronary artery bypass grafting, isolated valve repair/replacement, or combined CABG and valve repair/replacement
- Cardiac surgery performed through median sternotomy
You will not qualify if you...
- Body Mass Index greater than 40
- Refusal to give consent
- Prior or current lung transplant patients
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 96 hours after surgery or until discharge from the intensive care unit (ICU), whichever comes first.
Participants receive one of three hyperinflation respiratory therapies after cardiac surgery to support lung recovery in the intensive care unit.
Therapy sessions every 4 hours with daily pulmonary function evaluations
Trial Site Locations
Total: 1 location
1
UT Southwestern Clements University Hospital
Dallas, Texas, United States, 75390
Actively Recruiting
Research Team
J
Jaffer Odeh, MD
E
Emily Melikman, RN
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
3
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here