A Randomized Trial of the Hypotension Prediction Index in the Cardiac Operating Room and the Intensive Care Unit
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 170
- 试验地点
- 2
- 主要终点
- Assessment if the use of the AcumenTM HPI Feature Software reduces the mean duration of hypotension (defined as MAP < 65mmHg)
研究概览
简要总结
A prospective single-center randomized controlled trial to determine if guided hemodynamic management with the Acumen HPI technology in the OR and ICU can reduce the mean duration of hypotension in cardiac surgery patients requiring cardiopulmonary bypass.
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
- •Subjects who are at least 18 years of age
- •Subjects who have signed the Informed Consent Form
- •Subjects with planned pressure monitoring with an arterial line
- •Subjects with planned sternotomy
- •Subjects with planned general anesthesia
- •Subjects who have ASA Physical Status ≤ 4
- •Subjects with planned cerebral oximetry monitoring
- •Subjects with planned overnight hospitalization
- •Subjects with planned cardiopulmonary bypass (CPB) "on-pump" surgery
排除标准
- •Subjects with a physical site area too limited for proper Sensor placement
- •Subjects with contraindications for Arterial Line Placement;
- •Subjects participating in another (interventional) study
- •Subjects in whom an intraoperative MAP target will be < 65 mmHg
- •Subjects with pre-op or pre-pump or post-pump LVEF < 15%
- •Subjects requiring heart transplant
- •Subjects with pre-existing circulatory support devices or planned circulatory support devices post-bypass
- •Subjects requiring emergency surgery
- •Subjects with known or identified severe PAH (defined as pulmonary systolic pressure> 70mmHg or mean pressures > 55mmHg) as determined by a pre-operative echo or intraoperative Swan-Ganz
- •Subjects with cardiovascular instability in the operating room necessitating the need to go back on bypass for a subsequent run
研究组 & 干预措施
HPI Arm
AcumenTM HPI Software Feature to guide hemodynamic management in cardiac surgery post-CPB
干预措施: AcumenTM HPI Software Feature (Device)
Non-HPI Arm
Non-protocolized standard of care management per clinician and provider judgement.
干预措施: Non-protocolized Standard of Care (Other)
结局指标
主要结局
Assessment if the use of the AcumenTM HPI Feature Software reduces the mean duration of hypotension (defined as MAP < 65mmHg)
时间窗: From post-bypass period to the first 8-hour ICU period
Assessment if the use of the AcumenTM HPI Feature Software reduces the mean duration of hypotension (defined as MAP \< 65mmHg)
次要结局
未报告次要终点