Hypotension Prediction Index for Prevention of Hypotension During Cardiac Surgery: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 110
- 试验地点
- 2
- 主要终点
- TWA (time-weighted average) of intraoperative hypotension
研究概览
简要总结
Hypotension prediction index (HPI) was applied in various types of non-cardiac surgery with convincing benefits of preventing hypotensive events and clinical sequelae. Although HPI was validated in cardiac surgery, its clinical benefits are not proven yet. We aim to evaluate its effects on intraoperative hypotension and postoperative adverse events in cardiac surgery. In this randomized, single-blind trial, we will enroll adults scheduled for elective primary cardiac surgery under general anesthesia. Participants will be randomly assigned to intraoperative HPI-guided or non-HPI-guided hemodynamic management. The primary endpoint is the time-weighted average intraoperative hypotension below a mean arterial pressure threshold of 65 mmHg. The secondary endpoints are postoperative complications.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Care Provider)
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
- •elective, primary, isolated coronary arterial bypass surgery (CABG) or isolated valve surgery
- •provide inform consent.
排除标准
- •arrhythmia (e.g., atrial fibrillation, atrial flutter)
- •intracardiac shunts
- •preoperative inotropic usage
- •preoperative supportive devices usage (e.g., intra-aortic balloon pump, extracorporeal membrane oxygenation, left ventricular assist device, or right ventricular assist device)
- •receiving urgent or emergent procedures.
研究组 & 干预措施
HPI-guided
The arterial line of patients in HPI-guided arm will be connected to HemoSphere advanced monitoring platform (EV1000), which will provide HPI value calculated with Acumen Hypotension Prediction Index software.
干预措施: Hypotension prediction index (HPI) (Device)
non-HPI-guided
The arterial line of patients in non-HPI-guided arm will also be connected to HemoSphere advanced monitoring platform (EV1000) and all hemodynamic parameters will be calculated and showed as HPI-guided arm EXCEPT that the HPI value will not be shown on screen.
结局指标
主要结局
TWA (time-weighted average) of intraoperative hypotension
时间窗: From induction to the end of surgery. (If cardiopulmonary bypass (CPB) is adopted, the time of CPB will not be counted in)
Time-weighted average of intraoperative hypotension below 65 mmHg
次要结局
- length of ICU stay(after surgery until ICU discharge, assessed up to 30 days)
- length of hospital stay(after surgery until hospital discahrge, assessed up to 30 days)
- duration of hypotension(from induction to the end of surgery (excluding CPB time))
- postoperative complications(after surgery until discharge, assessed up to 30 days)
- incidence of hypotension(from induction to the end of surgery (excluding CPB time))
研究者
Ying-Chun Lin
Attending physician
Mackay Memorial Hospital