TEE and Dysphagia in Lung Transplantation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of California, Los Angeles
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adult patients
Single or double lung transplantation
Disqualifiers
perforated esophagus;
esophageal stricture;
esophageal tumor; and
history of an esophagectomy
Trial design
Design model
Parallel
Treatments tested in this trial
Transesophageal Echocardiography (TEE) with limited number of TEE clips
Diagnostic testThe 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 testThe control group would leave the number of TEE clips to the discretion of the attending anesthesiologist.
Treatment groups
116 Participants
are divided into 2 treatment groupsGroup A: Transesophageal Echocardiography (TEE) with limited number of TEE clipsExperimental treatment 1 intervention
Group B: Transesophageal Echocardiography (TEE) with number of TEE clips per attending anesthesiologistOther 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Postoperative Day 1 (POD1)Secondary outcomes
1
Mortality
In-hospital 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.2
Length of Intubation
Number of hours intubated from POD0 to extubation.
Time frame
From time of intubation until time to extubation, in hours, on average POD0 or POD1.3
Length of intensive care unit (ICU) Stay
Number of days in the ICU from POD0 to discharge from the ICU.
Time frame
From time of admission to the ICU (POD0) until discharge from the ICU. An average of 3-5 days.4
Length of Hospital Stay
Number of days in the hospital from POD0 to discharge from the hospital.
Time frame
From time of admission to the ICU (POD0) until discharge from the hospital, An average of 5-10 days.Sponsors and contacts
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Source ClinicalTrials.gov