NCT03805217已完成不适用
Prospective, Single-Arm, Open-Label, Multicenter Study of Hypotension Prevention and Treatment in Patients Receiving Arterial Pressure Monitoring with Acumen™ Hypotension Prediction Index Feature Software
Edwards Lifesciences11 个研究点 分布在 1 个国家目标入组 485 人开始时间: 2019年5月16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
- 485
- 试验地点
- 11
- 主要终点
- Reduction of Intraoperative Hypotension
研究概览
简要总结
A prospective, single-arm, open-label, multicenter post-approval study to determine whether the use of the Acumen HPI Software to guide intraoperative hemodynamic management in non-cardiac surgery reduces the duration of intraoperative hypotension below a threshold of Mean Arterial Pressure (MAP)
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 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
- •Written informed consent;
- •Age ≥ 18 years;
- •ASA Physical Status 3 or 4;
- •Moderate- or high-risk non-cardiac surgery (for example, orthopedic, spine, urology, and general surgery);
- •Planned pressure monitoring with an arterial line;
- •General anesthesia;
- •Surgery duration expected to last ≥ 3 hours from induction;
- •Planned overnight hospitalization.
排除标准
- •Participating in another (interventional) study;
- •Contraindication to the invasive blood pressure monitoring;
- •Patient who is confirmed to be pregnant and/or nursing mothers;
- •Emergency surgery;
- •Known clinically important intra-cardiac shunts;
- •Patient in whom an intraoperative MAP target will be < 65 mmHg;
- •Known aortic stenosis with valve area ≤ 1.5 cm2;
- •Known moderate to severe aortic regurgitation;
- •Known moderate to severe mitral regurgitation;
- •Known moderate to severe mitral stenosis;
- •Patient or surgical procedure type known as an SVV limitation (5) (e.g. tidal volume <8mL/kg of theoretical ideal weight, spontaneous ventilation, persistent cardiac arrhythmia, known atrial fibrillation, open chest surgery, Heart Rate/Respiratory Rate (HR/RR) ratio <3.6);
- •Current persistent atrial fibrillation;
- •Known acute congestive heart failure;
- •Craniotomy;
- •Surgery duration expected to last < 3 hours;
- •Burn surgeries;
- •Patients with an intra-aortic balloon pump (IABP) or ventricular assist device(s);
- •Patient transfer from ICU requiring multiple vasoactive agents and known diagnosis of ongoing active sepsis.
结局指标
主要结局
Reduction of Intraoperative Hypotension
时间窗: Duration of Surgery
Duration (t \[min\]) reduction of intraoperative hypotension (defined as MAP \< 65 mmHg for at least 1 minute) as compared with a historic retrospective control group
次要结局
- Intraoperative Hypotension in Each Subject(Duration of Surgery)
研究者
研究点 (11)
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