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TEE and Dysphagia in Lung Transplantation

Primary Purpose

Lung Transplant, Dysphagia

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Transesophageal Echocardiography (TEE) with limited number of TEE clips
Transesophageal Echocardiography (TEE) with number of TEE clips per attending anesthesiologist
Sponsored by
University of California, Los Angeles
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Lung Transplant focused on measuring Lung Transplantation, Dysphagia, Transesophageal Echocardiography (TEE), Outcomes

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Adult patients Single or double lung transplantation Exclusion Criteria: Contraindications to TEE including: perforated esophagus; esophageal stricture; esophageal tumor; and history of an esophagectomy Patients that require a tracheostomy postoperatively.

Sites / Locations

  • Ronald Reagan UCLA Medical Center, Department of Anesthesiology & Perioperative Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Transesophageal Echocardiography (TEE) with limited number of TEE clips

Transesophageal Echocardiography (TEE) with number of TEE clips per attending anesthesiologist

Arm Description

The intervention group would limit the number of TEE clips per case.

The control group would leave the number of TEE clips to the discretion of the attending anesthesiologist.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Mortality
In-hospital mortality
Length of Intubation
Number of hours intubated from POD0 to extubation.
Length of intensive care unit (ICU) Stay
Number of days in the ICU from POD0 to discharge from the ICU.
Length of Hospital Stay
Number of days in the hospital from POD0 to discharge from the hospital.

Full Information

First Posted
September 26, 2023
Last Updated
October 12, 2023
Sponsor
University of California, Los Angeles
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1. Study Identification

Unique Protocol Identification Number
NCT06089434
Brief Title
TEE and Dysphagia in Lung Transplantation
Official Title
Transesophageal Echocardiography (TEE) and Dysphagia in Lung Transplantation (LT)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 2023 (Anticipated)
Primary Completion Date
October 2025 (Anticipated)
Study Completion Date
November 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Los Angeles

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Transplant, Dysphagia
Keywords
Lung Transplantation, Dysphagia, Transesophageal Echocardiography (TEE), Outcomes

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
116 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Transesophageal Echocardiography (TEE) with limited number of TEE clips
Arm Type
Experimental
Arm Description
The intervention group would limit the number of TEE clips per case.
Arm Title
Transesophageal Echocardiography (TEE) with number of TEE clips per attending anesthesiologist
Arm Type
Other
Arm Description
The control group would leave the number of TEE clips to the discretion of the attending anesthesiologist.
Intervention Type
Diagnostic Test
Intervention Name(s)
Transesophageal Echocardiography (TEE) with limited number of TEE clips
Intervention Description
The intervention group would be limited to fewer than 20 TEE clips per case (versus the average of ~ 80-100 TEE clips per case).
Intervention Type
Diagnostic Test
Intervention Name(s)
Transesophageal Echocardiography (TEE) with number of TEE clips per attending anesthesiologist
Intervention Description
The control group would leave the number of TEE clips to the discretion of the attending anesthesiologist.
Primary Outcome Measure Information:
Title
Number of participants with dysphagia
Description
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
POD1
Secondary Outcome Measure Information:
Title
Mortality
Description
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.
Title
Length of Intubation
Description
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.
Title
Length of intensive care unit (ICU) Stay
Description
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.
Title
Length of Hospital Stay
Description
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adult patients Single or double lung transplantation Exclusion Criteria: Contraindications to TEE including: perforated esophagus; esophageal stricture; esophageal tumor; and history of an esophagectomy Patients that require a tracheostomy postoperatively.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jennifer Scovotti, MA
Phone
(424) 440-0936
Email
jscovotti@mednet.ucla.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
J.Prince Neelankavil, MD
Organizational Affiliation
University of California, Los Angeles
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ronald Reagan UCLA Medical Center, Department of Anesthesiology & Perioperative Medicine
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jennifer Scovotti, MA
Phone
424-440-0936
Email
jscovotti@mednet.ucla.edu
First Name & Middle Initial & Last Name & Degree
J. Prince Neelankavil, MD
First Name & Middle Initial & Last Name & Degree
Jonathan Ho, MD
First Name & Middle Initial & Last Name & Degree
Reed Harvey, MD
First Name & Middle Initial & Last Name & Degree
Sophia Poorsattar, MD

12. IPD Sharing Statement

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TEE and Dysphagia in Lung Transplantation

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