Non-invasive Early Goal Directed Therapy in Colorectal Surgery: a Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Postoperative complications
研究概览
简要总结
The Nexfin monitoring system offers a complete non-invasive approach to a continuously estimation of blood pressure, CI and PPV by means of finger-cuff based pulse contour analysis. Several clinical investigations have proven reliability and interchangeability of the Nexfin technology yielding acceptable results especially regarding the trending abilities. At present there is no evidence available, whether a early goal directed hemodynamic optimization protocol based on a completely non-invasive monitoring technology is able to reduce postoperative complication. Therefore, the aim of this single-center study is to compare the clinical outcome and postoperative complications of patients undergoing major colorectal surgery treated with standard of care or with a GDT protocol based on the Nexfin technology.
详细描述
The Nexfin™ monitoring system is able to provide continuous beat-to-beat stroke volume index (SVI), stroke volume variation (SVV), pulse pressure variation (PPV), cardiac index (CI) and arterial pressure by using an inflatable finger cuff. This system consists of a frequency dependent transfer function for calculation of brachial artery pressure from the finger artery pressure.
Major surgery bares the risk of concealed hypoperfusion and therefore possible mismatch in oxygen delivery and oxygen demand. It must be noted, that the "basic" perioperative monitoring, i.e. electrocardiogram, oxygen saturation and non-invasive or invasive blood pressure measurements is not able to accurately detect hypovolemia and ongoing organ hypoperfusion. Perioperatively, patients undergoing major abdominal surgery are prone to high risk of hemodynamic instabilities and consequently relevant changes in oxygen delivery, associated with an increase in postoperative complications and length of stay in hospital. Over the last years several studies focused on early goal directed hemodynamic therapy (GDT) with strong proof for the feasibility of such algorithms and the improvement in patient's outcome with respect to certain clinical scenarios.However, there is still a debate regarding an individualized GDT approach, based on pre-procedural defined individualized hemodynamic goals yielded by an advanced haemodynamic monitoring technology. We do have to distinguish which monitoring system, invasive to non-invasive, matches the kind of estimated risk at what time best.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Major abdominal procedures
- •Estimated duration ≥120 minutes
- •High transfusion probability
- •Anticipated blood loss ≥1000 ml
排除标准
- •Patients less than 18 years old
- •ASA I or IV classification
- •Heart rhythm disorders
- •Advanced peripheral artery occlusive disease
- •Arteriovenous shunts concerning upper extremities
- •Laparoscopic abdominal procedures
研究组 & 干预措施
Study group (SG)
Before induction of anaesthesia:
- Arterial line
- Nexfin Monitoring System
- Measurement of cardiac index (CI), pulse pressure variation (PPV) and mean arterial pressure (MAP)
- Baseline blood samples. Induction of anaesthesia
Study Group:
- PPV ≤10%, 500 ml of crystalloids/colloids as long as CI was ≥2.5 l/min/m²
- Maintenance of CI ≥2.5 l/min/m² and MAP ≥65 mmHg by using dobutamine (10 µg/kg/min) and norepinephrine (0.03 µg/kg/min).
干预措施: Dobutamine (Drug)
结局指标
主要结局
Postoperative complications
时间窗: 28 days
次要结局
- Length of hospital stay (LOS)(28 days)
研究者
Ole Broch, MD
Priv.-Doz. Dr. med. Ole Broch
University Hospital Schleswig-Holstein