TEE Techniques for Swallowing Difficulty After Lung Transplant

Overseen By Jennifer Scovotti, MA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, Los Angeles

Disqualifiers: Perforated esophagus, esophageal stricture, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 1 day

116 Participants Needed

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. ^{1 2 3 4 5}

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. ^{1 3 4 6 7}

Who Is on the Research Team?

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?

Group I: Transesophageal Echocardiography (TEE) with number of TEE clips per attending anesthesiologist Experimental Treatment 1 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 clips Experimental Treatment 1 Intervention

The intervention group would limit the number of TEE clips per case.

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:

• Cardiovascular imaging
• Monitoring during surgical procedures

Approved in European Union as Transesophageal Echocardiography for:

• Cardiovascular imaging
• Monitoring during surgical procedures

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

In a study of 1,500 transesophageal echocardiography (TEE) procedures, only 1.6% of attempts failed to introduce the probe, indicating a high success rate, especially as most failures occurred during the initial learning phase.

No serious complications were reported, and minor incidents occurred in only 1.9% of cases, demonstrating that TEE is a safe procedure when performed by trained professionals, supporting its valuable role in cardiology.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Failure and complications of transesophageal echocardiography. Apropos of 1500 consecutive cases]. Vignon, P., Guéret, P., Chabernaud, JM., et al.[2016]

Transesophageal echocardiography (TEE) is a valuable tool for assessing various cardiac conditions in critically ill patients, including left ventricular function and valvular diseases, especially in those who are ventilated.

TEE is more effective than transthoracic echocardiography for identifying cardiac sources of embolism, but it has contraindications such as esophageal disorders and uncorrected bleeding issues that must be considered before use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transesophageal echocardiography: expanding indications for ICU use. How TEE can complement--or surpass--transthoracic techniques. Ofili, EO., Labovitz, AJ.[2016]

Transesophageal echocardiography (TEE) provides clear images of the heart by positioning an ultrasonic transducer in the esophagus, making it especially useful for assessing conditions like left atrial masses and mitral valve disease.

In a review of the first 100 patients at Toronto Western Hospital, TEE was effectively used to detect early myocardial ischemia during noncardiac surgeries and to evaluate the outcomes of valvular surgeries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transesophageal echocardiography: experience of a Canadian centre. Cujec, B., Sullivan, H., Wilansky, S., et al.[2008]

Transesophageal echocardiography (TEE) is increasingly used in critical care by various medical professionals, including intensivists and anesthesiologists, highlighting its growing importance in patient management.

The review summarizes the expanding clinical applications and diagnostic benefits of TEE, indicating its versatility and utility in assessing cardiovascular conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Overview of transesophageal echocardiography for the chest physician. Milani, RV., Lavie, CJ., Gilliland, YE., et al.[2019]

In a study of 95 patients with prior esophageal surgery who underwent 145 transesophageal echocardiograms (TEEs), image quality was compromised in 16% of cases, and comprehensive diagnostic studies were only completed in 57% of patients, indicating challenges in performing TEE in this population.

Despite these challenges, serious complications from TEE were rare, occurring in only 1% of patients, suggesting that while TEE can be performed safely, careful pre-procedure assessments and a conservative approach are recommended for patients with a history of esophageal surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and feasibility of transesophageal echocardiography in patients with prior esophageal surgery. Smith, BB., Rehfeldt, KH., Meinhardt, JR., et al.[2021]

Transesophageal echocardiography (TEE) is increasingly important in both cardiac and noncardiac procedures, but difficulties in probe insertion can lead to serious complications, highlighting the need for careful management.

The review provides evidence-based tips for TEE insertion and explores alternative imaging options, aiming to guide anesthesiologists in handling challenges during TEE placement effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Difficult TEE Probe Placement: The Evidence, Troubleshooting Techniques, and a Guide to Alternative Monitoring Options for Intraoperative Physicians. Hillenbrand, KD., Racine, CL., McNeil, JS., et al.[2020]

In a study of 6255 adult cardiac surgical patients, the incidence of complications associated with transesophageal echocardiography (TEE) was very low at 0.4%.

The most common complication was oropharyngeal mucosal bleeding, occurring in 60% of the cases, while more serious issues like esophageal perforation were rare, indicating that TEE is generally safe for use during cardiac operations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Complications of intraoperative transesophageal echocardiography in adult cardiac surgical patients - experience of two institutions in Taiwan. Huang, CH., Lu, CW., Lin, TY., et al.[2016]

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06089434

NCT06089434 | TEE and Dysphagia in Lung Transplantation

The primary outcome of this study is dysphagia (difficulty swallowing) on postoperative speech and swallow evaluation following lung transplantation.

2.

uclahealth.org

uclahealth.org/clinical-trials/tee-and-dysphagia-lung-transplantation

TEE and Dysphagia in Lung Transplantation

The primary outcome of this study is dysphagia (difficulty swallowing) on postoperative speech and swallow evaluation following lung transplantation.

3.

withpower.com

withpower.com/trial/phase-deglutition-disorders-10-2023-003bc

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.gov

pubmed.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

5.

jhltonline.org

jhltonline.org/article/S1053-2498(21)02460-8/fulltext

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 ...

6.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S0041134524005475

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.

7.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S1053249822019362

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.