Clinical trial NCT06089434: TEE and Dysphagia in Lung Transplantation
Official title: Transesophageal Echocardiography (TEE) and Dysphagia in Lung Transplantation (LT)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Lung Transplant
Dysphagia
Keywords: Lung Transplantation
Dysphagia
Transesophageal Echocardiography (TEE)
Outcomes
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
First posted: 2023-10-18
Enrollment: 116
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Number of participants with dysphagia
timeFrame: Postoperative Day 1 (POD1)
Secondary outcomes:
measure: Mortality
timeFrame: 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.
measure: Length of Intubation
timeFrame: From time of intubation until time to extubation, in hours, on average POD0 or POD1.
measure: Length of intensive care unit (ICU) Stay
timeFrame: From time of admission to the ICU (POD0) until discharge from the ICU. An average of 3-5 days.
measure: Length of Hospital Stay
timeFrame: From time of admission to the ICU (POD0) until discharge from the hospital, An average of 5-10 days.
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Ronald Reagan UCLA Medical Center, Department of Anesthesiology & Perioperative Medicine
state: California
Study officials:
affiliation: University of California, Los Angeles
name: J.Prince Neelankavil, MD
role: PRINCIPAL_INVESTIGATOR
References: