Lung TransplantNCT06089434
TEE and Dysphagia in Lung Transplantation
A study testing Transesophageal Echocardiography (TEE) with limited number of TEE clips and Transesophageal Echocardiography (TEE) with number of TEE clips per attending anesthesiologist in people with Lung Transplant and Dysphagia, run by University of California, Los Angeles at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Transplant, Dysphagia
- What is being tested?
- Transesophageal Echocardiography (TEE) with limited number of TEE clips and Transesophageal Echocardiography (TEE) with number of TEE clips per attending anesthesiologist
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Jul 2024to 13 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients
- Single or double lung transplantation
Who cannot join
- Contraindications to TEE including:
- perforated esophagus;
- esophageal stricture;
- esophageal tumor; and
- history of an esophagectomy
- Patients that require a tracheostomy postoperatively.
Trial locations and contacts
1 site in 1 country.
United States1 site
Ronald Reagan UCLA Medical Center, Department of Anesthesiology & Perioperative Medicine
Los Angeles, California, 90095
About this study
Official title: 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.
Read the 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
- Being tested
- Transesophageal Echocardiography (TEE) with limited number of TEE clips, Transesophageal Echocardiography (TEE) with number of TEE clips per attending anesthesiologist
- Keywords
- Lung Transplantation, Dysphagia, Transesophageal Echocardiography (TEE), Outcomes
- Medical subject headings
- Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transesophageal Echocardiography (TEE) with limited number of TEE clipsDiagnostic 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 anesthesiologistDiagnostic test
The control group would leave the number of TEE clips to the discretion of the attending anesthesiologist.
| Study group | Role | What they receive |
|---|---|---|
| Transesophageal Echocardiography (TEE) with limited number of TEE clips | Experimental | The intervention group would limit the number of TEE clips per case. Receives: Diagnostic Test: Transesophageal Echocardiography (TEE) with limited number of TEE clips |
| Transesophageal Echocardiography (TEE) with number of TEE clips per attending anesthesiologist | Other | The control group would leave the number of TEE clips to the discretion of the attending anesthesiologist. Receives: Diagnostic Test: Transesophageal Echocardiography (TEE) with number of TEE clips per attending anesthesiologist |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Postoperative Day 1 (POD1)
Secondary outcomes (4)
Mortality
In-hospital mortality
Measured: 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
Number of hours intubated from POD0 to extubation.
Measured: From time of intubation until time to extubation, in hours, on average POD0 or POD1.
Length of intensive care unit (ICU) Stay
Number of days in the ICU from POD0 to discharge from the ICU.
Measured: From time of admission to the ICU (POD0) until discharge from the ICU. An average of 3-5 days.
Length of Hospital Stay
Number of days in the hospital from POD0 to discharge from the hospital.
Measured: From time of admission to the ICU (POD0) until discharge from the hospital, An average of 5-10 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2023
- Study start12 Jul 2024
- Primary completion13 Dec 2025
- Study completion13 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung TransplantStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jacques Neelankavil, University of California, Los Angeles
- Investigators
- J.Prince Neelankavil, MD, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06089434
- Sponsor's protocol ID
- 23-000600
- Status last verified
- Jul 2026
- First submitted
- 26 Sep 2023
- Last updated
- 21 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transesophageal Echocardiography (TEE) and Dysphagia in Lung Transplantation (LT)
- ClinicalTrials.gov ID
- NCT06089434
- Acronym / sponsor ID
- 23-000600
- Conditions
- Lung Transplant, Dysphagia
- Keywords
- Lung Transplantation, Dysphagia, Transesophageal Echocardiography (TEE), Outcomes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Study start
- 12 Jul 2024 (actual)
- Primary completion
- 13 Dec 2025 (actual)
- Study completion
- 13 Jan 2026 (actual)
- First posted
- 18 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transesophageal Echocardiography (TEE) with limited number of TEE clips | Experimental | Diagnostic Test: Transesophageal Echocardiography (TEE) with limited number of TEE clipsThe intervention group would limit the number of TEE clips per case. |
| Transesophageal Echocardiography (TEE) with number of TEE clips per attending anesthesiologist | Other | Diagnostic Test: Transesophageal Echocardiography (TEE) with number of TEE clips per attending anesthesiologistThe control group would leave the number of TEE clips to the discretion of the attending anesthesiologist. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult patients
- Single or double lung transplantation
Key exclusion criteria (6 listed)
- Contraindications to TEE including:
- Patients that require a tracheostomy postoperatively.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transesophageal Echocardiography (TEE) with limited number of TEE clipsThe intervention group would be limited to fewer than 20 TEE clips per case (versus the average of ~ 80-100 TEE clips per case). | Diagnostic test | Transesophageal Echocardiography (TEE) with limited number of TEE clips |
| Transesophageal Echocardiography (TEE) with number of TEE clips per attending anesthesiologistThe 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 |
Primary outcome
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.
4 secondary outcomes
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.
Length of Intubation
Time frame: 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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
J.Prince Neelankavil, MD principal investigator
University of California, Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transesophageal Echocardiography (TEE) with limited number of TEE clips and Transesophageal Echocardiography (TEE) with number of TEE clips per attending anesthesiologist in people with Lung Transplant and Dysphagia, run by University of California, Los Angeles at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with dysphagia (time frame: Postoperative Day 1 (POD1)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2026.