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临床试验/NCT02287753
NCT02287753已完成不适用

Relationship Between Parameters of Vascular Occlusion Test Using Near Infrared Spectroscopy and Clinical Parameters & Outcomes in Pediatric Cardiac Surgery

Seoul National University Hospital1 个研究点 分布在 1 个国家目标入组 130 人开始时间: 2013年11月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
130
试验地点
1
主要终点
Major adverse event

研究概览

简要总结

The purpose of this study is to evaluate the ability of vascular occlusion test (VOT) during cardiac surgery to predict postoperative outcomes in pediatric patients.

详细描述

After induction of anesthesia, pediatric SomaSensor for INVOS 5100C is attached at calf muscle and non-invasive blood pressure cuff is applied to ipsilateral thigh. VOT is performed as: after baseline oxygen saturation value is recorded, cuff pressure is rapidly increased to 30 mmHg over than systolic blood pressure. After 3 minutes of ischemic time, cuff pressure is rapidly decreased. It is performed at 3 time periods : before start of operation, during cardiopulmonary bypass, and after weaning from cardiopulmonary bypass. Postoperative outcome variables are recorded after surgery : major adverse event, use of inotropic and vasoactive drugs, duration of mechanical ventilation and ICU stay. The relationship between the results of VOT and postoperative outcome will be investigated.

研究设计

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

入排标准

年龄范围
— 至 8 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Pediatric patients aged under 8 years old who are scheduled for cardiac surgery

排除标准

  • Skin disease
  • Skin preparation involving thigh
  • Peripheral vascular disease

结局指标

主要结局

Major adverse event

时间窗: up to 1 years after surgery

Major adverse event is defined as cardiac compression, re-sternotomy because of hemodynamic instability, ECMO support, Cr\> 2mg/dL, cerebral hemorrhage or infarct and mortality.

次要结局

  • Length of mechanical ventilation time and ICU stay(up to 1 years after surgery)
  • Use of inotropic and vasoactive drugs(up to 1 years after surgery)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jin-Tae Kim

assistant professor

Seoul National University Hospital

研究点 (1)

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