Transesophageal Echocardiography (TEE) and Dysphagia in Lung Transplantation (LT)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 112
- 试验地点
- 2
- 主要终点
- Number of participants with dysphagia
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients
- •Single or double lung transplantation
排除标准
- •Contraindications to TEE including:
- •perforated esophagus;
- •esophageal stricture;
- •esophageal tumor; and
- •history of an esophagectomy
- •Patients that require a tracheostomy postoperatively.
研究组 & 干预措施
Transesophageal Echocardiography (TEE) with limited number of TEE clips
The intervention group would limit the number of TEE clips per case.
干预措施: Transesophageal Echocardiography (TEE) with limited number of TEE clips (Diagnostic Test)
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.
干预措施: Transesophageal Echocardiography (TEE) with number of TEE clips per attending anesthesiologist (Diagnostic Test)
结局指标
主要结局
Number of participants with dysphagia
时间窗: 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.
次要结局
- Length of Intubation(From time of intubation until time to extubation, in hours, on average POD0 or POD1.)
- Length of Hospital Stay(From time of admission to the ICU (POD0) until discharge from the hospital, An average of 5-10 days.)
- Mortality(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 intensive care unit (ICU) Stay(From time of admission to the ICU (POD0) until discharge from the ICU. An average of 3-5 days.)
研究者
Jacques Neelankavil
Principal Investigator and Professor of Clinical Anesthesiology
University of California, Los Angeles