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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

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

Study 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.Check my eligibility

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.See study design

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.

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of Texas Southwestern Medical CenterLead Sponsor

1,047 Previous Clinical Trials

1,053,475 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

EzPAP (Respiratory Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04164173 — N/A

Postoperative Complications Research Study Groups: EzPAP, Metaneb, Intermittent Positive Pressure Breathing (IPPB)

Postoperative Complications 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many people are eligible to participate in the current clinical trial?

"Affirmative. As evidenced on clinicaltrials.gov, this medical experiment which was made public on June 15th 2020 is actively recruiting participants at present. Specifically, 324 individuals are required for the trial to be conducted at a single centre."

Answered by AI

Is this research involving elderly individuals?

"The inclusion criteria for this clinical trial require that qualified participants are between 18 and 80 years of age. There are 8 trials catered specifically to minors, while 139 studies focus on individuals above the senior citizen threshold."

Answered by AI

Do I fit the criteria for involvement in this experiment?

"Prospective participants in this research should have experienced postoperative issues and fall between the age of consent and 80 years old. We intend to recruit a total of 324 individuals for this study."

Answered by AI

Are there still opportunities to join this medical experiment?

"Affirmative. Clinicaltrials.gov holds evidence that this medical experiment, first posted on June 15th 2020, is still recruiting patients. Up to 324 individuals will be involved, from one clinical site only."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Hyperinflation Respiratory Therapies in Cardiac Surgery Patients

Jaffer Odeh 2020. "Hyperinflation Respiratory Therapies in Cardiac Surgery Patients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04164173.

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