NCT05105477终止不适用
Hypotension Prediction Index (HPI) Software Guided Hemodynamic Management for Noncardiac Surgery Patients - Blood Pressure Trial (National PI: Kamal Maheshwari, MD, MPH)
Edwards Lifesciences21 个研究点 分布在 1 个国家目标入组 407 人开始时间: 2021年11月17日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 407
- 试验地点
- 21
- 主要终点
- A Composite of 30-day Moderate-to-severe Perfusion Related Postoperative Complications.
研究概览
简要总结
A multicenter, randomized comparison of intraoperative hemodynamic management with or without a protocolized strategy utilizing Hypotension Prediction Index (HPI) software guidance during moderate-to-high-risk noncardiac surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Prevention
- 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
- •Signed informed consent
- •Age >18 years
- •ASA Physical Status > 2
- •Noncardiac surgery with expected surgery duration > 2 hours (example include: orthopedic, spine, urology, and general surgery)
- •Planned blood pressure monitoring with an arterial line catheter;
- •General anesthesia;
排除标准
- •Participating in another interventional Trial;
- •Contraindication to arterial blood pressure monitoring;
- •Subjects with a physical site area too limited for proper Sensor placement
- •Serum creatine > 175 μmol/L (>2.0 mg/dL) or CKD stage > 3A
- •Scheduled for intracranial surgery with permissive hypotension;
- •Patient who is confirmed to be pregnant and/or nursing mothers;
- •Patients with an intra-aortic balloon pump (IABP) or ventricular assist device(s);
- •Have a condition that precludes routine or tight blood pressure management such as surgeon request for relative hypotension;
- •Emergency surgery;
- •Require beach-chair positioning;
- •Scheduled for cardiac surgeries
- •Have previously participated in the SMART-BP trial.
结局指标
主要结局
A Composite of 30-day Moderate-to-severe Perfusion Related Postoperative Complications.
时间窗: From post non-cardiac surgery to 30 days.
A composite of 30-day moderate-to-severe perfusion related postoperative complications.
次要结局
未报告次要终点
研究者
研究点 (21)
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