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临床试验/NCT04872504
NCT04872504Unknown不适用

Performance of the Hypotension Prediction Index With Invasive Arterial Pressure Waveform in Liver Transplantation

Chang Gung Memorial Hospital2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2021年5月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
60
试验地点
2
主要终点
Accurate hypotension prediction of EV1000 system

研究概览

简要总结

A prospective, open-label and single-center study to determine whether the use of Acumen Hypotension Prediction Index software predicts the occurrence of hypotension.

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
20 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Written informed consent
  • Age ≥ 20 years;
  • Scheduled liver transplantation
  • Planned pressure monitoring with an arterial line;
  • General anesthesia

排除标准

  • Contraindication for invasive blood pressure monitoring
  • End-staged renal disease
  • pre-operative MAP <65 mmHg
  • Severe heart failure
  • Severe cardiac shunt
  • Severe aortic stenosis
  • Severe atrial fibrillation

结局指标

主要结局

Accurate hypotension prediction of EV1000 system

时间窗: MAP measurements of each case were recorded every 20 s by the EV1000 system from induction to the end of surgery, assessed up to 1 day.

Analyze the actual incidence of hypotension after HPI alarm more than 85 within 15 min

Severity of intraoperative hypotension

时间窗: MAP measurements of each case were recorded every 20 s by the EV1000 system from induction to the end of surgery, assessed up to 1 day

MAP measurements were recorded every 20 s by the EV1000 system from induction to Time-weighted average mean arterial pressure (TWA-MAP) \< 65 mmHg

Incidence of intraoperative hypotension

时间窗: MAP measurements of each case were recorded every 20 s by the EV1000 system from induction to the end of surgery, assessed up to 1 day

Frequency, duration of intraoperative hypotension, which defined as MAP \< 65 mmHg at least 1 min

次要结局

  • Hospital stay and ICU stay(Days from admission to discharge, assessed up to 1 month)
  • Adverse effects(Days from admission to discharge, assessed up to 1 month)
  • Mortality after surgery(Days from admission to discharge, assessed up to 1 month)

研究者

发起方
Chang Gung Memorial Hospital
申办方类型
Other
责任方
Sponsor

研究点 (2)

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