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临床试验/NCT03422107
NCT03422107Unknown不适用

Clinical Assessment of a Novel Automated SSEP Monitor for Detection and Management of Intraoperative Positional Neuropraxia

Western University, Canada1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2017年11月20日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
100
试验地点
1
主要终点
Cumulative duration of abnormal SSEP

研究概览

简要总结

PNI (Peripheral Nerve Injury) occurs in 5-15% of patients in cardiac surgery. So far, the mechanism of injury has never been researched. In this study, we will compare minimally invasive cardiac surgery with conventional cardiac surgery using a novel portable SSEP device to pinpoint the mechanism and timing of PNI during cardiac surgery.

详细描述

General objectives The general objective of this study is to identify the causative insults during various kinds of cardiac surgeries. To attain this objective, we have three specific aims. Firstly, surgical insults such as excessive or asymmetric sternal retraction have long been regarded as the main causes of PNI. Therefore, we will investigate this by comparing cardiac surgeries with sternotomy to the ones without sternotomy. Secondly, more and more cardiac surgeons utilize minimally invasive techniques these days. In the current study, we will investigate the incidence, mechanisms and patterns of PNI in minimally invasive cardiac surgeries by comparing conventional surgeries to minimally invasive surgeries. Thirdly, recent studies have suggested systematic insults such as ischemia, inflammation, and underlying neuropathy might play more prominent roles in the mechanism of PNI. In this study, we will analyze various factors such as intraoperative hemodynamics and baseline patient characteristics to pinpoint the most responsible factors.

Background The studies regarding mechanisms of PNI in cardiac surgeries have not been done over the past few decades. With respect to minimally invasive cardiac surgeries, no studies have been done to investigate the mechanism of PNI.

Regarding the device used in this study The conventional SSEP device is large in size, invasive, and requires expertise to interpret. These characteristics have prevented its use in the operating room. This new portable SSEP device is devoid of these properties.

Significance Identification of causative insults will help clinicians to recognize and possibly prevent PNI during cardiac surgeries.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 95 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • ●all adult (age>18, <95 years of age) cardiac surgical patients who are undergoing the four following procedures, open AVR, TAVI, conventional CABG, robotic CABG

排除标准

  • any patients with contraindication to SSEP monitoring, which include skin burns or trauma at SSEP electrode sites
  • lack of written consent
  • emergency surgery
  • language barrier
  • fluctuating neurological signs/symptoms
  • regional anesthesia (spinal, epidural, nerve block)
  • CABG with radial artery harvest, combined cardiac surgeries

结局指标

主要结局

Cumulative duration of abnormal SSEP

时间窗: From the beginning of the surgery to the end of surgery

Defined as the amplitude reduction \>50% from baseline, Latency\>10% from baseline

次要结局

  • The incidence of postoperative peripheral neuropathy at post-operative day 2-5(Post operative day 2 to 5)
  • The number of SSEP abnormal alarms(From the beginning of the surgery to the end of surgery)

研究者

发起方
Western University, Canada
申办方类型
Other
责任方
Sponsor

研究点 (1)

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