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Respiratory Therapy

Respiratory Therapies for Postoperative Lung Recovery

N/A
Recruiting
Research Sponsored by University of Texas Southwestern Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Cardiac surgery performed via median sternotomy
Age 18 years and older
Must not have
Prior or current lung transplant patients
Refusal to be consented
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 96 hours postoperatively or until discharge from the intensive care unit (icu), whichever came first.
Awards & highlights

Summary

This trial will compare three different types of therapies to see which is best at expanding lungs and improving recovery after surgery.

Who is the study for?
This trial is for adults over 18 who are in the Cardiovascular ICU after certain heart surgeries like bypass or valve repair. They must have had their surgery through a cut down the middle of the chest. It's not for those with a BMI over 40, those who don't consent to participate, or patients with past or current lung transplants.
What is being tested?
The study is comparing three breathing treatments—IPPB, EzPAP, and Metaneb—to see which one helps lungs recover better after heart surgery. Patients will be randomly assigned to receive one of these therapies as they recuperate.
What are the potential side effects?
Potential side effects from these respiratory therapies may include discomfort while using the devices, possible shortness of breath during treatment, and rarely some might experience increased pressure in the lungs.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I had heart surgery through a cut down the center of my chest.
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I am 18 years old or older.
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I was admitted to the CVICU after heart surgery.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had a lung transplant.
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I do not agree to participate in this study.
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My BMI is over 40.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 96 hours postoperatively or until discharge from the intensive care unit (icu), whichever came first.
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 96 hours postoperatively or until discharge from the intensive care unit (icu), whichever came first. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Postoperative lung function as assessed by the changes in FEV1/FVC

Trial Design

3Treatment groups
Experimental Treatment
Group I: MetanebExperimental Treatment1 Intervention
The patient will have Metaneb postoperative respiratory therapy as 10 minutes Continuous Positive End Expiratory Pressure (CPEP) four times daily
Group II: Intermittent Positive Pressure Breathing (IPPB)Experimental Treatment1 Intervention
The patient will have Intermittent positive pressure breathing (IPPB) postoperatively for 10 minutes four times daily
Group III: EzPAPExperimental Treatment1 Intervention
The patient will have EzPAP postoperative respiratory therapy as 3 x 10 breaths at a 1:4 ratio four times daily
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
EzPAP
2014
Completed Phase 4
~60

Find a Location

Who is running the clinical trial?

University of Texas Southwestern Medical CenterLead Sponsor
1,072 Previous Clinical Trials
1,055,938 Total Patients Enrolled
Jaffer Odeh, MDStudy Chair - UT Southwestern Medical Center
Children's Medical Center of Dallas, The University of Texas Southwestern Medical Center At Dallas, UT Southwestern Medical Center-Zale Lipshy Campus

Media Library

EzPAP (Respiratory Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04164173 — N/A
Lung Disease Research Study Groups: EzPAP, Metaneb, Intermittent Positive Pressure Breathing (IPPB)
Lung Disease Clinical Trial 2023: EzPAP Highlights & Side Effects. Trial Name: NCT04164173 — N/A
EzPAP (Respiratory Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04164173 — N/A
~62 spots leftby Sep 2025
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