116 Participants Needed

TEE Techniques for Swallowing Difficulty After Lung Transplant

JS
Overseen ByJennifer Scovotti, MA
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of California, Los Angeles
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether reducing the number of heart images taken during lung transplants can lessen swallowing difficulties afterward. It uses a heart imaging technique called transesophageal echocardiography (TEE), which captures images from inside the body. Participants are divided into two groups: one with limited TEE images and the other with the number determined by the doctor. This trial suits adults who have had single or double lung transplants and do not have specific esophagus issues. As an unphased trial, it offers participants the chance to contribute to innovative research that could enhance post-transplant recovery.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this TEE technique is safe for patients with swallowing difficulty after lung transplant?

Research has shown that transesophageal echocardiography (TEE) is a common procedure during lung transplants. TEE, which involves taking pictures of the heart from inside the body, is generally safe. This study examines whether the number of TEE images, or "clips," affects swallowing difficulties after surgery.

While there is limited direct information on the safety of taking fewer TEE clips, TEE itself is well-known and widely used. Complications are rare, though some patients might experience mild throat discomfort. The study focuses on whether reducing the number of clips can alleviate swallowing issues post-transplant. Overall, TEE is a common practice and is considered safe for most patients.12345

Why are researchers excited about this trial?

Researchers are excited about these techniques for managing swallowing difficulties after lung transplants because they explore how varying the number of transesophageal echocardiography (TEE) clips could impact patient outcomes. Unlike traditional approaches where the number of TEE clips is determined entirely by the attending anesthesiologist, this trial examines whether limiting the clips could reduce complications or improve recovery. This investigation could lead to a more standardized and potentially safer protocol for patients experiencing swallowing issues post-transplant.

What evidence suggests that limiting TEE clips is effective for reducing swallowing difficulty after lung transplant?

Research shows that Transesophageal Echocardiography (TEE) is often used during lung transplants to monitor the heart. However, some studies suggest that this procedure might make swallowing difficult afterward. One study found that TEE image quality was affected in some patients who had previous esophageal surgery, indicating possible complications. This trial will compare two approaches: one arm will limit the number of TEE clips taken during the procedure, while the other arm will allow the attending anesthesiologist to determine the number of TEE clips. The current research investigates whether taking fewer images during TEE could reduce the risk of swallowing problems after lung transplants. Although solid data on this idea is not yet available, the study aims to determine if a simpler approach could help.13467

Who Is on the Research Team?

JN

J.Prince Neelankavil, MD

Principal Investigator

University of California, Los Angeles

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I am 18 years old or older.
I have had a lung transplant.

Exclusion Criteria

I do not have any conditions that make throat exams unsafe, like a torn esophagus or throat surgery history.
I will need a tracheostomy after surgery.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo lung transplantation with TEE performed, randomized to either limited or standard number of TEE clips

1 day
1 visit (in-person, surgical procedure)

Postoperative Evaluation

Postoperative speech and swallow evaluation performed by a speech/language therapist

1 day
1 visit (in-person, bedside evaluation)

Follow-up

Participants are monitored for dysphagia and other outcomes until discharge from the hospital

5-10 days

What Are the Treatments Tested in This Trial?

Interventions

  • Transesophageal Echocardiography (TEE) with limited number of TEE clips
  • Transesophageal Echocardiography (TEE) with number of TEE clips per attending anesthesiologist
Trial Overview 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.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Group I: Transesophageal Echocardiography (TEE) with number of TEE clips per attending anesthesiologistExperimental Treatment1 Intervention
Group II: Transesophageal Echocardiography (TEE) with limited number of TEE clipsExperimental Treatment1 Intervention

Transesophageal Echocardiography (TEE) with limited number of TEE clips is already approved in United States, European Union for the following indications:

🇺🇸
Approved in United States as Transesophageal Echocardiography for:
🇪🇺
Approved in European Union as Transesophageal Echocardiography for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of California, Los Angeles

Lead Sponsor

Trials
1,594
Recruited
10,430,000+

Published Research Related to This Trial

In a study of 99,081 patients aged 65 and older who experienced ischemic stroke or TIA, transesophageal echocardiography (TEE) did not increase the risk of respiratory failure compared to those who did not undergo the procedure, with a cumulative risk of 1.4% for both groups.
The analysis showed that after adjusting for various factors, TEE was not associated with a higher likelihood of requiring intubation or mechanical ventilation, indicating that it can be performed safely in this patient population.
Transesophageal echocardiography and risk of respiratory failure in patients who had ischemic stroke or transient ischemic attack: an IDEAL phase 4 study.Bruce, SS., Navi, BB., Zhang, C., et al.[2022]
The TEDRAS study, involving 34 acute stroke patients, found that transesophageal echocardiography (TEE) significantly worsened swallowing ability for at least 24 hours post-procedure, as measured by increased dysphagia severity scores.
Specifically, patients in the intervention group showed significant increases in secretion severity and Penetration-Aspiration Scale scores immediately after and 24 hours after TEE, indicating a clear negative impact on their swallowing function.
Transesophageal Echocardiography - Dysphagia Risk in Acute Stroke (TEDRAS): a prospective, blind, randomized and controlled clinical trial.Hamzic, S., Braun, T., Butz, M., et al.[2021]
Transesophageal echocardiography (TEE) is increasingly utilized in liver transplantation, with over 90% of responding centers having at least one team member using it, indicating its growing importance in clinical practice.
A majority of liver transplant anesthesiologists (83.9%) recognize the unique clinical value of TEE, but opinions are divided on whether future training should focus on basic certification or more hands-on, site-specific training.
Use, Training, and Opinions About Effectiveness of Transesophageal Echocardiography in Adult Liver Transplantation Among Anesthesiologists in the United States.Zerillo, J., Hill, B., Kim, S., et al.[2018]

Citations

NCT06089434 | TEE and Dysphagia in Lung TransplantationThe primary outcome of this study is dysphagia (difficulty swallowing) on postoperative speech and swallow evaluation following lung transplantation.
TEE and Dysphagia in Lung TransplantationThe primary outcome of this study is dysphagia (difficulty swallowing) on postoperative speech and swallow evaluation following lung transplantation.
TEE Techniques for Swallowing Difficulty After Lung ...In a study of 95 patients with prior esophageal surgery who underwent 145 transesophageal echocardiograms (TEEs), image quality was compromised in 16% of cases, ...
4.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/40636077/
Transesophageal echocardiography during lung ...Lung transplantation (LTx) continues to be the primary curative intervention for end-stage lung disease, with post-transplant outcomes
Swallowing and laryngeal complications in lung and ...This paper explores the potential mechanisms of oropharyngeal dysphagia and dysphonia following transplantation and discusses optimal modalities of diagnostic ...
Incidence and Risk Factors for Clinically Significant ...The aim of this retrospective, single-center study was to determine the incidence of clinically significant OPD in lung transplant recipients.
Incidence, risk factors, and sequelae of dysphagia ...Of those who underwent both a pre- and postoperative swallowing exam (n = 170), preoperatively 83% demonstrated safe swallowing and 17% unsafe swallowing.
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Terms of Service·Privacy Policy·Cookies·Security