NCT04972266已完成不适用
European Hypotension Prediction Index Real World Experience Using AcumenTM Hypotension Prediction Index Software to Prevent Intraoperative Hypotension: the Multicentre Prospective Observational Registry
Edwards Lifesciences12 个研究点 分布在 5 个国家目标入组 702 人开始时间: 2021年9月28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
- 702
- 试验地点
- 12
- 主要终点
- To describe the time-weighted average (TWA) mean arterial pressure (MAP) <65 mmHg when using AcumenTM Hypotension Prediction Index software
研究概览
简要总结
European, multicenter, prospective, observational registry in patients undergoing elective major non-cardiac surgery
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- 否
入选标准
- •Consenting adult patients (≥18 years)
- •Patient is scheduled for elective major non-cardiac surgery under general anesthesia that is expected to last at least 120 minutes and in whom blood pressure is monitored using an arterial catheter
- •Patients in whom the AcumenTM Hypotension Prediction Index software with the Acumen IQ sensor on the Hemosphere platform is used intraoperatively
排除标准
- •Patients undergoing emergency surgery OR nephrectomy, liver and/or kidney transplantation
- •Patients suffering from atrial fibrillation and/or sepsis (according to current Sepsis-3 definition)
- •American Society of Anesthesiology (ASA) physical status classification V or VI
- •Disability and/or other circumstances under which the patient is not able to understand the nature, significance and scope of the investigation
- •Pregnancy at the time of surgery
- •Patients without signed informed consent / data protection statement
- •Patient participating in other interventional trials
结局指标
主要结局
To describe the time-weighted average (TWA) mean arterial pressure (MAP) <65 mmHg when using AcumenTM Hypotension Prediction Index software
时间窗: Duration of the procedure through 30 days after procedure
To describe the time-weighted average (TWA) mean arterial pressure (MAP) \<65 mmHg when using AcumenTM Hypotension Prediction Index software
次要结局
未报告次要终点
研究者
研究点 (12)
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