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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
No Placebo-Only Group
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 belowSelect...
I had heart surgery through a cut down the center of my chest.
Select...
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:Select...
I have had a lung transplant.
Select...
I do not agree to participate in this study.
Select...
My BMI is over 40.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 96 hours postoperatively or until discharge from the intensive care unit (icu), whichever came first.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 96 hours postoperatively or until discharge from the intensive care unit (icu), whichever came first.
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
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
1,083 Previous Clinical Trials
1,057,865 Total Patients Enrolled
1 Trials studying Postoperative Complications
288 Patients Enrolled for Postoperative Complications
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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had a lung transplant.I had heart surgery through a cut down the center of my chest.I am 18 years old or older.I do not agree to participate in this study.I was admitted to the CVICU after heart surgery.My BMI is over 40.
Research Study Groups:
This trial has the following groups:- Group 1: EzPAP
- Group 2: Metaneb
- Group 3: Intermittent Positive Pressure Breathing (IPPB)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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