Influence of the "Hypotension Probability Index" on the Number and Duration of Intraoperative Hypotension in Primary Hip Endoprosthetic Replacement
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Episode of hypotension
研究概览
简要总结
The aim of the study is to investigate the value of the Hypotension Probability Index in reducing intraoperative hypotension in patients with primary hip replacement. The measurement of the blood pressure was and is of great interest for the treating physician/anesthesiologist to optimize the peri- and postoperative patients outcome. The non-invasive measurement can scale the blood pressure but not from heartbeat-to-heartbeat, what results in a loss of information. The invasive measurement by a placed catheter in an artery shows the blood pressure with information about the pulse wave form, the ascending angle, and makes it possible to detect hemodynamic changes in a way the non-invasive blood pressure measurement is lacking. The additional informations of the monitoring and a
详细描述
Study design The study is designed as a single center randomized prospective interventional trial comparing goal directed hemodynamic management using HPI compared to standard care.
Subcenter University hospital of Giessen, Department of Anesthesiology, Operative Intensive Care and Pain Therapy (Study team: Dres. med. Christian Koch, Emmanuel Schneck, Thomas Zajonz, Dagmar Schulte, Fabian Edinger, Sophie Ruhrmann) 3.3 Study Population The study population is therefore divided into three groups.
- Intervention group (optimization based on HPI) n=25
- Control group (optimization based on standard monitoring without HPI) n=25
Inclusion Criteria
- Patients undergoing hip-replacement
- General anesthesia
- Age ≥ 18 years
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
Computer generated random list
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
- •Patients undergoing hip-replacement
- •General anesthesia
- •Age ≥ 18 years
排除标准
- •Participation in another (interventional) study
- •Pregnancy and nursing mothers
- •Surgery without controlled ventilation
- •ASA > III
- •Contraindication for invasive blood pressure monitoring
- •Renal insufficiency KDIGO Stadium ≥ 2
- •Coagulation disorder
研究组 & 干预措施
Intervention arm
HPI monitoring to predict hypotension
干预措施: Hypotension probability index (HPI) (Device)
Control arm
blinded HPI monitoring
结局指标
主要结局
Episode of hypotension
时间窗: up to 18 months
The aim of the study is to investigate whether a goal directed treatment according to the Hypotension Probability Index compared to standard care can reduce the incidence of intraoperative hypotension in patients with hip-replacement. As primary endpoints frequency (n)/h, absolute and relative duration (t \[min\]/% of total anesthesia time) of intraoperative hypotension were defined for this study.
次要结局
- Changes of catecholamine management(up to 18 months)
- Changes of fluid management(up to 18 months)
研究者
Dr. Christian Koch
MD, Principal investigator
University of Giessen