TEE and Dysphagia in Lung Transplantation

Dysphagia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06089434
• Other study ID #: 23-000600
• Status: Recruiting
• Phase: N/A
• Start date: June 2024
• Est. completion date: June 2026

Study information

• Verified date: May 2024
• Source: University of California, Los Angeles
• Contact: Jennifer Scovotti, MA
• Phone: (424) 440-0936
• Email: jscovotti[@]mednet.ucla.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 116
• Est. completion date: June 2026
• Est. primary completion date: May 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Deglutition Disorders
• Dysphagia
• Lung Transplant

Intervention

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).
• 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.

Locations

Country	Name	City	State
United States	Ronald Reagan UCLA Medical Center, Department of Anesthesiology & Perioperative Medicine	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Los Angeles

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	Length of Intubation	Number of hours intubated from POD0 to extubation.	From time of intubation until time to extubation, in hours, on average POD0 or POD1.
Secondary	Length of intensive care unit (ICU) Stay	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.
Secondary	Length of Hospital Stay	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.