跳至主要内容
临床试验/NCT03431870
NCT03431870Unknown不适用

Prospective Study to Examine the Impact of Anesthesia on the Dimension of the Ascending Aorta in Patients With a Dilated Aorta Who Undergo Open-heart Surgery

Sheba Medical Center2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2018年1月21日最近更新:
适应症

试验速览

阶段
不适用
入组人数
20
试验地点
2
主要终点
difference in the aortic dimension

研究概览

简要总结

The aim of this study is to evaluate the accuracy and reliability of intra-operative TEE after the induction of anesthesia when assessing proximal thoracic aorta diameters in a cohort of aortic aneurysm patients.

详细描述

Dilatation of the ascending aorta often progresses silently in an asymptomatic patient, until an acute complication occurs (such as a dissection or rupture), which is directly related to the diameter of the aortic. To prevent these extremely harmful situations, aortic replacement surgery, as indicated by significant dilatation of the ascending aorta, could be the option of choice (1). The decision to perform elective surgery depends on the measurement of the thoracic aorta diameter, which would rely on the largest aortic dimension. Trans-thoracic echocardiography (TTE) is widely used to assess the aortic root (2), and results from computed tomography (CT) scans are used to evaluate the ascending aorta beyond the sinotubular junction (3, 4). Both these tests facilitate follow-up evaluation of patients with thoracic aortic aneurysm. Usually, patients are referred for surgery based on the findings of one or both of these examinations. Furthermore, when a patient is referred for surgery, intra-operative trans-esophageal echocardiography (TEE) is often performed after induction of the anesthesia in order to evaluate the aortic dimension and valve function.

In some cases, the diameter of the aorta is considered borderline for replacement, in which case the TEE measurement could reverse the decision-making, especially when the indication for surgery is due to valve pathology, with the aorta being a secondary consideration.

From the investigators experience, intra-operative TEE aortic measurements after the anesthesia are not entirely accurate, and could under-estimate the diameter of the aorta. Relying on intra-operative TEE measurements could result in under-treatment of the dilated aorta, especially when its replacement is secondary to other cardiac pathologies (e.g. AVR, CABG) that require surgery.

Influence of intra-operative anesthesia on TEE measurements of the aorta are not described in the current literature. If the investigators hypothesis is correct, adjustments will need to be made regarding the surgical management of patients with borderline aortic dimensions.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Ascending aorta of 40 mm and above
  • Patients who undergo cardiac surgery

排除标准

  • Unstable patients
  • Patients who underwent a previous cardiac surgery
  • Patients who were diagnosed with aortic dissection

结局指标

主要结局

difference in the aortic dimension

时间窗: intraoperative

10% difference in the aortic dimension before and after anaesthesia

次要结局

未报告次要终点

研究者

申办方类型
Other Gov
责任方
Sponsor

研究点 (2)

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