Tight Systolic Arterial Pressure Control Using a Closed-loop System for Vasopressor Infusion in Patients Undergoing High-risk Abdominal Surgery: A Proof-of-Concept Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Percentage of case Time in hypotension (SAP <117 mmHg)
研究概览
简要总结
The purpose of this case series is to evaluate the performance of a novel closed-loop (automated) vasopressor administration system that delivers norepinephrine using feedback from standard operating room hemodynamic monitoring (EV1000 monitoring device, Edwards Lifesciences, Irvine, USA).
详细描述
In this case series, the investigators will report the percentage of case time in hypotension (defined as systolic arterial pressure (SAP) < 117mmHg). The target mean arterial pressure (MAP) will be set at a SAP of 130mmHg in all patients. Definition of Hypotension is target SAP - 10% (130mmHg - 13 mmHg = 117 mmHg). We will use the same SAP target in all patients even if we used a modified definition of hypotension from the study of Futier and colleagues ( JAMA 2017). We won't use a individualized SAP for each patient but the same SAP target in all patients.
The investigators want to demonstrate that the closed-loop system can prevent hypotension at this specific set point.
The Investigators have shown the system works well based on a target MAP but not yet using a target of SAP.
The investigators will test the system in a pilot study of 13 patients undergoing High-risk abdominal surgery which require the placement of a arterial catheter, the optimization of fluid therapy and a tight SAP control.
Participants will receive standard patient care in that in no way will their anesthetic or surgical procedure will be altered as part of the study, with the exception of vasopressor administration ( automatically delivery instead of manually adjustments)
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients (age of >17)
- •Elective high-risk abdominal surgery
- •Patients with an arterial line and in whom a goal directed fluid therapy protocol is applied manually (administration of fluid bolus to maintain a stroke volume variation < 13%)
排除标准
- •Atrial Fibrillation
- •Pregnancy
- •Subjects without the capacity to give informed consent
结局指标
主要结局
Percentage of case Time in hypotension (SAP <117 mmHg)
时间窗: At postoperative day 1
The primary outcome will be the percentage of case time in predefined SAP target (SAP of 130 mmHg -10 % = 117 mmHg)
次要结局
- Percentage of case time with a MAP < 65 mmHg(At postoperative day 1)
- Amount of vasopressors received(At postoperative day 1)
- Number of vasopressors infusion rate modifications(At postoperative day 1)
研究者
Alexandre Joosten, MD PhD
Principal Investigator
Erasme University Hospital