NCT05615168已完成不适用
Use of Hypotension Prediction Index to Reduce Intraoperative Hypotension in Major Thoracic Surgery
University Hospital Dubrava2 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2022年1月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 34
- 试验地点
- 2
- 主要终点
- Time weighted average of area under hypotensive threshold
研究概览
简要总结
Intraoperative hypotension is linked to increased incidence of perioperative adverse events such as myocardial and cerebrovascular infarction and acute kidney injury. Hypotension prediction index (HPI) is a novel machine learning guided algorithm which can predict hypotensive events using high fidelity analysis of pulse-wave contour. Goal of this trial is to determine whether use of HPI can reduce the number and duration of hypotensive events in patients undergoing major thoracic procedures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients over 18 years of age
- •patients scheduled for elective major thoracic procedure (lung resection, pleurectomy or resection of the esophagus)
- •planned thoracotomy and intraoperative period of one lung ventilation
- •planned postoperative admission to the ICU
排除标准
- •persistent atrial fibrillation
- •structural heart defects (shunting or moderate to severe valvular anomalies)
- •preoperative serum hemoglobin levels < 120 g/L
- •severe heart failure classified as New York Heart Association (NYHA) grade IV
结局指标
主要结局
Time weighted average of area under hypotensive threshold
时间窗: During surgery
次要结局
- Number of hypotensive events(During surgery)
- Cumulative duration of hypotension(During surgery)
研究者
Andrej Šribar
Prinicipal investigator, Head of division of cardiovascular anesthesiology
University Hospital Dubrava
研究点 (2)
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