TEE and Dysphagia in Lung Transplantation

January 11, 2024 updated by: Jacques Neelankavil, University of California, Los Angeles

Transesophageal Echocardiography (TEE) and Dysphagia in Lung Transplantation (LT)

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

116

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90095
        • Recruiting
        • Ronald Reagan UCLA Medical Center, Department of Anesthesiology & Perioperative Medicine
        • Contact:
        • Sub-Investigator:
          • Reed Harvey, MD
        • Principal Investigator:
          • J. Prince Neelankavil, MD
        • Sub-Investigator:
          • Jonathan Ho, MD
        • Sub-Investigator:
          • Sophia Poorsattar, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Transesophageal Echocardiography (TEE) with limited number of TEE clips
The intervention group would limit the number of TEE clips per case.
Diagnostic test: 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).
Other: 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with dysphagia
Time Frame: Postoperative Day 1 (POD1)
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mortality
Time Frame: 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.
In-hospital 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
Time Frame: From time of intubation until time to extubation, in hours, on average POD0 or POD1.
Number of hours intubated from POD0 to extubation.
From time of intubation until time to extubation, in hours, on average POD0 or POD1.
Length of intensive care unit (ICU) Stay
Time Frame: From time of admission to the ICU (POD0) until discharge from the ICU. An average of 3-5 days.
Number of days in the ICU from POD0 to discharge from the ICU.
From time of admission to the ICU (POD0) until discharge from the ICU. An average of 3-5 days.
Length of Hospital Stay
Time Frame: From time of admission to the ICU (POD0) until discharge from the hospital, An average of 5-10 days.
Number of days in the hospital from POD0 to discharge from the hospital.
From time of admission to the ICU (POD0) until discharge from the hospital, An average of 5-10 days.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, Los Angeles

Investigators

  • Principal Investigator: J.Prince Neelankavil, MD, University of California, Los Angeles

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 1, 2024

Primary Completion (Estimated)

January 1, 2026

Study Completion (Estimated)

February 1, 2026

Study Registration Dates

First Submitted

September 26, 2023

First Submitted That Met QC Criteria

October 12, 2023

First Posted (Actual)

October 18, 2023

Study Record Updates

Last Update Posted (Estimated)

January 15, 2024

Last Update Submitted That Met QC Criteria

January 11, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 23-000600

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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