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Procedure
TEE Techniques for Swallowing Difficulty After Lung Transplant
N/A
Recruiting
Led By J.Prince Neelankavil, MD
Research Sponsored by University of California, Los Angeles
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Single or double lung transplantation
Be older than 18 years old
Must not have
Contraindications to TEE including: perforated esophagus, esophageal stricture, esophageal tumor, and history of an esophagectomy
Patients that require a tracheostomy postoperatively.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up pod0 until discharge from the hospital. an average of 5-10 days until discharge from the hospital. a maximum of 30 days for in-hospital mortality.
Awards & highlights
No Placebo-Only Group
Summary
This trial is investigating if reducing the number of pictures taken of the heart during a lung transplant can reduce difficulty swallowing after surgery.
Who is the study for?
This trial is for adult patients undergoing single or double lung transplantation at UCLA. It's not suitable for individuals with conditions like a perforated esophagus, narrowed esophagus, esophageal cancer, or those who have had their esophagus removed. Patients needing a tracheostomy after surgery are also excluded.
What is being tested?
The study tests if limiting the number of TEE (heart imaging from inside the body) clips during lung transplant surgery can reduce swallowing difficulties afterwards. Participants will be randomly assigned to two groups: one with limited TEE clips and another where the attending anesthesiologist decides on the number of clips.
What are the potential side effects?
While this trial focuses on dysphagia as an outcome rather than side effects of medication, potential risks may include discomfort from TEE and complications related to fewer diagnostic images being available during surgery.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have had a lung transplant.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I do not have any conditions that make throat exams unsafe, like a torn esophagus or throat surgery history.
Select...
I will need a tracheostomy after surgery.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ pod0 until discharge from the hospital. an average of 5-10 days until discharge from the hospital. a maximum of 30 days for in-hospital mortality.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~pod0 until discharge from the hospital. an average of 5-10 days until discharge from the hospital. a maximum of 30 days for in-hospital mortality.
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Number of participants with dysphagia
Secondary study objectives
Length of Hospital Stay
Length of Intubation
Length of intensive care unit (ICU) Stay
+1 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Transesophageal Echocardiography (TEE) with number of TEE clips per attending anesthesiologistExperimental Treatment1 Intervention
The control group would leave the number of TEE clips to the discretion of the attending anesthesiologist.
Group II: Transesophageal Echocardiography (TEE) with limited number of TEE clipsExperimental Treatment1 Intervention
The intervention group would limit the number of TEE clips per case.
Find a Location
Who is running the clinical trial?
University of California, Los AngelesLead Sponsor
1,562 Previous Clinical Trials
10,262,245 Total Patients Enrolled
J.Prince Neelankavil, MDPrincipal InvestigatorUniversity of California, Los Angeles
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