Department of Anesthesiology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, Beijing, China.
Department of Cardiac Surgery, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, Beijing, China.
Trials. 2024 Aug 13;25(1):535. doi: 10.1186/s13063-024-08338-9.
In cardiac surgical procedures, patients carrying high-risk profiles are prone to encompass complicated cardiopulmonary bypass (CPB) separation. Intraoperative transesophageal echocardiography (TEE), a readily available tool, is utilized to detect cardiac structural and functional pathologies as well as to facilitate clinical management of CPB separation, especially in the episodes of hemodynamic compromise. However, the conventional TEE examination, always performed in a liberal fashion without any restriction of view acquisition, is relatively time-consuming; there appear its flaws in the context of critically severe status. We therefore developed the perioperative rescue transesophageal echocardiography (PReTEE), a simplified three-view TEE protocol consisting of midesophageal four chamber, midesophageal left ventricular long axis, and transgastric short axis.
This is a single-center and randomized controlled trial which will be implemented in Peking Union Medical College Hospital, Beijing, China. A total of 46 TEE scans are schemed to be performed by 6 operators participating in and randomly assigned to either the PReTEE or the conventional TEE group. This study is purposed to investigate whether the efficiency of discriminating leading causes of difficult CPB wean-off can be significantly improved via an abbreviated sequence of TEE views. The primary outcome of interest is the difference between the groups of PReTEE and the conventional TEE in the successful discrimination of etiologies in specified 120 s. Cox proportional hazards model will be further employed to calculate the outcome difference.
The estimated results of this trial are oriented at verifying whether a simplified TEE exam sequence can improve the efficiency of etiologies discrimination during CPB separation in cardiac surgery.
ClinicalTrials.gov NCT05960552. Registered on 6 July 2023.
在心脏外科手术中，高风险患者容易出现复杂的体外循环（CPB）分离。术中经食管超声心动图（TEE）作为一种随时可用的工具，用于检测心脏结构和功能病理学，并有助于 CPB 分离的临床管理，尤其是在出现血液动力学不稳定的情况下。然而，常规 TEE 检查总是以无任何视图获取限制的宽松方式进行，相对耗时；在危急重症情况下存在缺陷。因此，我们开发了围术期抢救经食管超声心动图（PReTEE），一种简化的三切面 TEE 方案，包括食管中段四腔心切面、食管中段左心室长轴切面和经胃短轴切面。
这是一项在中国北京协和医院进行的单中心、随机对照试验。共有 6 名操作人员参与并随机分配到 PReTEE 或常规 TEE 组，每组进行 46 次 TEE 扫描。本研究旨在探讨通过缩短 TEE 视图序列是否可以显著提高区分 CPB 脱机困难的主要原因的效率。主要研究结果是在 120 秒内，PReTEE 组与常规 TEE 组在成功区分病因方面的差异。进一步采用 Cox 比例风险模型计算结果差异。
该试验的估计结果旨在验证简化的 TEE 检查序列是否可以提高心脏手术中 CPB 分离时病因鉴别效率。
ClinicalTrials.gov NCT05960552. 注册于 2023 年 7 月 6 日。
