TEE and Dysphagia in Lung Transplantation

NCT ID: NCT06089434

Last Updated: 2025-07-18

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 116 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-12
• Study Completion Date: 2026-07-31

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.

Detailed Description

Dysphagia is a common complication after cardiac surgery and specifically after lung transplantation. The incidence of dysphagia after lung transplantation is approximately 40-50%. Dysphagia after cardiac surgery leads to a significant increase in mortality, morbidity, cost, and length of stay. There are several risk factors that have been identified retrospectively including patient comorbidities, length of surgery, length of intubation, and number of TEE clips obtained during surgery. Many of these risk factors are not modifiable, however, the number of TEE clips obtained is a potential area for intervention. Retrospective studies demonstrate that a high number of TEE clips may be associated with dysphagia postoperatively. TEE should not be completely eliminated from these procedures because it adds value for patient management and the diagnosis of intraoperative complications.

This is a prospective, cluster randomized study for adult patients undergoing single and double lung transplantation. Groups will be randomized by month. The primary outcome of the study is dysphagia on postoperative speech and swallow evaluation.

TEE is routinely performed for all lung transplantation at UCLA and it is the standard of care. Patients would be randomized to two groups. The intervention group would be limited to fewer than 20 TEE clips per case. The control group would leave the number of TEE clips to the discretion of the attending anesthesiologist (average ~80-100 TEE clips per case). The current standard of care is to leave the number of TEE clips to the discretion of the attending anesthesiologist (the control arm). The attending anesthesiologist has the ability to obtain more TEE clips in the intervention arm if they feel it will be beneficial to patient care.

The postoperative speech and swallow evaluation is standard of care for all lung transplant recipients and would be done regardless of participation in the study. This is a bedside evaluation done by a speech/language therapist after the patient has been extubated, usually performed on postoperative day (POD) 1.

Data will also be collected and recorded from the medical record.

Conditions

Lung Transplant; Dysphagia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Transesophageal Echocardiography (TEE) with limited number of TEE clips

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

Group Type: EXPERIMENTAL

Transesophageal Echocardiography (TEE) with limited number of TEE clips

Intervention Type: 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 number of TEE clips per attending anesthesiologist

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

Group Type: OTHER

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

Intervention Type: DIAGNOSTIC_TEST

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

Interventions

Transesophageal Echocardiography (TEE) with limited number of TEE clips

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

Intervention Type: DIAGNOSTIC_TEST

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

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

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

1. Adult patients

2. Single or double lung transplantation

Exclusion Criteria

1. Contraindications to TEE including:

• perforated esophagus;
• esophageal stricture;
• esophageal tumor; and
• history of an esophagectomy

2. Patients that require a tracheostomy postoperatively.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of California, Los Angeles

OTHER

Sponsor Role: lead

Responsible Party

Jacques Neelankavil

Principal Investigator and Professor of Clinical Anesthesiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

J.Prince Neelankavil, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, Los Angeles

Locations

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

Los Angeles, California, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Jennifer Scovotti, MA

Role: CONTACT

jscovotti@mednet.ucla.edu

(424) 440-0936

Facility Contacts

Jennifer Scovotti, MA

Role: primary

jscovotti@mednet.ucla.edu

424-440-0936

Other Identifiers

23-000600

Identifier Type: -

Identifier Source: org_study_id