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临床试验/NCT03323619
NCT03323619Unknown不适用

Impact of Anesthesia Technique on Post-operative Delirium After Transcatheter Aortic Valve Implantation

Central Hospital, Nancy, France1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2017年11月2日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
200
试验地点
1
主要终点
Delirium

研究概览

简要总结

Aortic stenosis is a frequent valvulopathy in Europe and North America. It occurs mainly over 65 years (2-7% of the population over 65 years). Treatment of symptomatic stenosis is an indication of aortic valve replacement. For patients with high surgical risk (EuroSCORE II> 6), TAVI (Transcatheter Aortic Valve Implantation) is recommended. This type of procedure concerns elderly patients (75-80 years on average in the literature) therefore the anesthesia technique must be optimal. The postoperative complications are, on the one hand, well-described surgical complications (Cardiogenic shock, bleeding, rhythm disorders, renal insufficiency) and, on the other hand, those related to anesthesia which are less well characterized. There is no consensus on best anesthesia technique for TAVI procedure managment. Between teams practices are different. It may consist of general anesthesia (GA) or local anesthesia with sedation (LASed). Elderly anesthesia has specific complications, including acute cerebral disturbances (delirium) usually occurring within 24 to 48 hours postoperatively and up to 7 days. It is recommended to screen delirium for patients admitted in intensive care using the CAM-ICU scale. The aim of the study is to observe the impact of the anesthesia technique (GA versus LASed) on delirium in post-operative aortic valve replacement with TAVI procedure

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Hospital admission for TAVI femoral way
  • Age > 18 years
  • Psychiatric disease

排除标准

  • Opposition of the operator (Interventional Cardiologist or Surgeon) to one of the two anesthesia technique
  • Contraindication to local anesthesia with sedation: agitation, delirium, allergy to local anesthetics, risk of inhalation
  • Opposition of the patient to use his data for research

结局指标

主要结局

Delirium

时间窗: 7 days

post-operative delirium after TAVI

次要结局

  • ICU stay(30 days)

研究者

发起方
Central Hospital, Nancy, France
申办方类型
Other
责任方
Sponsor

研究点 (1)

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