Actively Recruiting

Phase Not Applicable
Age: 18Years - 80Years
All Genders
ID04164173

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

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Implementation

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

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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

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