TEE and Dysphagia in Lung Transplantation

NCT06089434 | Recruiting

• 1 other identifier: 23-000600
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 1

Brief Summary

The primary outcome of this study is dysphagia (difficulty swallowing) on postoperative speech and swallow evaluation following lung transplantation. Transesophageal echocardiography (TEE) (creates pictures of the heart from inside the participants body) is routinely performed for all lung transplantations at the University of California, Los Angeles (UCLA) and it is the standard of care. Patients are randomized to two groups. The intervention group would limit the number of TEE clips (# pictures taken) per case. The control group would leave the number of TEE clips to the discretion of the attending anesthesiologist. The investigators hypothesize that reduction in TEE imaging during lung transplantation will reduce dysphagia.

Conditions

Lung Transplant; Dysphagia

Keywords

Lung Transplantation; Dysphagia; Transesophageal Echocardiography (TEE); Outcomes

Outcome Measures

Primary Outcomes (1)

• Number of participants with dysphagia

  Dysphagia on the postoperative speech and swallow evaluation. Dysphagia is classified into 3 major classifications: swallowing without limitations, swallowing with limitations, and inability to swallow.

  Postoperative Day 1 (POD1)

Secondary Outcomes (4)

• Mortality

  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.

• Length of Intubation

  From time of intubation until time to extubation, in hours, on average POD0 or POD1.

• Length of intensive care unit (ICU) Stay

  From time of admission to the ICU (POD0) until discharge from the ICU. An average of 3-5 days.

• Length of Hospital Stay

  From time of admission to the ICU (POD0) until discharge from the hospital, An average of 5-10 days.

Study Arms (2)

Transesophageal Echocardiography (TEE) with limited number of TEE clips

EXPERIMENTAL

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

Diagnostic Test: Transesophageal Echocardiography (TEE) with limited number of TEE clips

Transesophageal Echocardiography (TEE) with number of TEE clips per attending anesthesiologist

OTHER

The control group would leave the number of TEE clips to the discretion of the attending anesthesiologist.

Diagnostic Test: Transesophageal Echocardiography (TEE) with number of TEE clips per attending anesthesiologist

Interventions

Transesophageal Echocardiography (TEE) with limited number of TEE clips DIAGNOSTIC_TEST

The intervention group would be limited to fewer than 20 TEE clips per case (versus the average of \~ 80-100 TEE clips per case).

Transesophageal Echocardiography (TEE) with limited number of TEE clips

Transesophageal Echocardiography (TEE) with number of TEE clips per attending anesthesiologist DIAGNOSTIC_TEST

The control group would leave the number of TEE clips to the discretion of the attending anesthesiologist.

Transesophageal Echocardiography (TEE) with number of TEE clips per attending anesthesiologist

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients
• Single or double lung transplantation

You may not qualify if:

• Contraindications to TEE including:
• perforated esophagus;
• esophageal stricture;
• esophageal tumor; and
• history of an esophagectomy
• Patients that require a tracheostomy postoperatively.

Sponsors & Collaborators

• University of California, Los Angeles: lead

Study Sites (1)

Ronald Reagan UCLA Medical Center, Department of Anesthesiology & Perioperative Medicine

Los Angeles, California, 90095, United States

RECRUITING

MeSH Terms

Conditions

Deglutition Disorders

Interventions

Echocardiography, Transesophageal

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Echocardiography; Cardiac Imaging Techniques; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Ultrasonography; Heart Function Tests; Diagnostic Techniques, Cardiovascular

Study Officials

• J.Prince Neelankavil, MD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jennifer Scovotti, MA

CONTACT

(424) 440-0936; jscovotti@mednet.ucla.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator and Professor of Clinical Anesthesiology

Study Record Dates

• First Submitted: September 26, 2023
• First Posted: October 18, 2023
• Study Start: July 12, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: July 18, 2025

Record last verified: 2025-07

Locations

US (1)