Ignite Creation Date:
2024-05-06 @ 7:39 PM
Last Modification Date:
2024-10-26 @ 3:11 PM
Study NCT ID:
NCT06089434
Status:
RECRUITING
Last Update Posted:
2024-05-08
First Post:
2023-09-26
Brief Title:
TEE and Dysphagia in Lung Transplantation
Sponsor:
University of California Los Angeles
Organization:
University of California Los Angeles
Study Overview
Official Title:
Transesophageal Echocardiography TEE and Dysphagia in Lung Transplantation LT
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 speechlanguage 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
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 speechlanguage 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None