Acumen HPI Smart Alerts and Smart Trends to Improve Compliance With an Intra-operative Hemodynamic Management Algorithm and Reduce Renal Injury Following Major Elective Noncardiac Surgery.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 296
- 试验地点
- 16
- 主要终点
- HPI Smart Alert
研究概览
简要总结
A multicenter, interventional, feasibility comparison with historical controls
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Other
- 盲法
- None
盲法说明
HemoSphere ClearSight Module and Pressure Controller, and adult Acumen IQ finger cuff
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
- •Elective noncardiac surgery with expected surgery duration ≥ 3 hours and expected post-operative length of stay of ≥ 3 days
- •Planned monitoring with an arterial catheter; Cohort 2: without planned arterial catheter insertion
- •General anesthesia with tracheal intubation and positive pressure ventilation
排除标准
- •Inability to comply with the study intra-operative hemodynamic management algorithm such as surgeon request for relative hypotension or fluid restriction or avoidance of vasopressors
- •Planned vasopressor or inotrope infusion during surgery
- •Contraindication to intra-arterial blood pressure monitoring
- •Has previously participated in the SMART TRENDS study
- •Serum creatine > 2.0 mg/dL (> 175 μmol/L) or CKD stage > 3A
- •Scheduled for intracranial or cardiac surgery
- •Patient who is known to be pregnant
- •Patients on mechanical circulatory support
- •Emergency surgery
- •Planned beach-chair positioning
- •Additional Exclusion Criteria for Cohort 2 only:
- •Extreme contraction of the smooth muscle in the arteries and arterioles of the lower arm and hand, such as may be present in patients with Raynaud's disease
- •Finger or hand deformity that prevents proper placement of finger cuff by visual inspection
- •Inability to place Acumen IQ finger cuffs due to subject anatomy, condition, or obstructive paraphernalia (such as false nails)
研究组 & 干预措施
SMART TRENDS - Acumen IQ Sensor
Acumen HPI Smart Alerts and Smart Trends Software Feature to guide hemodynamic management in moderate-to-high-risk noncardiac surgery.
干预措施: Acumen HPI Smart Alerts and Smart Trends Software (Device)
SMART TRENDS - Acumen IQ Cuff
Acumen HPI Smart Alerts and Smart Trends Software Feature to guide hemodynamic management in moderate-to-high-risk noncardiac surgery.
干预措施: The HemoSphere advanced monitoring platform with Acumen HPI software, and Acumen IQ sensor and Acumen IQ cuff (Device)
结局指标
主要结局
HPI Smart Alert
时间窗: From start to end of non-cardiac surgery
The proportion of HPI Smart Alert prompts displayed resulting in initiation of action within 5 minutes consistent with an intra-operative hemodynamic management algorithm.
次要结局
未报告次要终点