TEE and Dysphagia in Lung Transplantation

Part of paid clinical trials in Los Angeles, California.

Sponsor
University of California, Los Angeles
Study ID
NCT06089434
Status
Recruiting

Conditions

  • Dysphagia
  • Lung Transplant

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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 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.

Study Details

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.

Key Dates

Start date
Jul 12, 2024
Status verified
Jul 2025
Primary completion
Jun 30, 2026
Completion
Jul 31, 2026

Study Design

Enrollment
116 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Transesophageal Echocardiography (TEE) with limited number of TEE clips
    The intervention group would limit the number of 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.

Primary Outcome Measure

Number of participants with dysphagia [ Time Frame: Postoperative Day 1 (POD1) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Ronald Reagan UCLA Medical Center, Department of Anesthesiology & Perioperative MedicineLos AngelesCalifornia90095
Jennifer Scovotti, MA
424-440-0936
J. Prince Neelankavil, MD (PRINCIPAL_INVESTIGATOR)
Jonathan Ho, MD (SUB_INVESTIGATOR)
Reed Harvey, MD (SUB_INVESTIGATOR)
Sophia Poorsattar, MD (SUB_INVESTIGATOR)

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