The Accuracy of Ultrasound Derived Carotid, Femoral and Brachial Artery Compared to Conventional Intra-vascular Methods Flow-related Parameters
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Cardiac output
研究概览
简要总结
Rationale: Diligent fluid management is instrumental to improve postoperative outcome, cost and quality of care.
Objective: To determine the accuracy of brachial, femoral and carotid blood flow measurement with ultrasound compared to intermittent transpulmonary thermodilution cardiac output measurement, invasive and non-invasive pulse-contour analysis.
Study design: Observational study - Prospective clinical non-intervention measurement study.
Study population: Adult ASA 1-2 patients, scheduled for open upper GI surgery Intervention (if applicable): Not applicable. We will perform non-invasive ultrasound measurements of the femoral, carotid and brachial blood flow right before induction and under anaesthesia.
Main study parameters/endpoints: Femoral, carotid and brachial blood flow determined by ultrasound and blood flow variation and the accuracy compared to transpulmonary thermodilution cardiac output, stroke volume variation, and pulse-contour analysis derived cardiac output (invasive or non-invasive) at the following time points during surgery; (limited for femoral site as it cannot be measured during surgery): (1) before induction of anaesthesia, (2) after induction, (3) 15 minutes after start of surgery, (4) before and (5) after (1-2 minutes) a fluid bolus, (6) before and (7) after start of vasopressors, (8) before and (9) after Trendelenburg position and (10) after surgery before end of anaesthesia (figure 1). A fluid bolus will be performed as part of standard care (goal-directed fluid therapy). The vasopressor and Trendelenburg position time points are optional measurements. We will also measure (continuous) invasive femoral blood pressure (SBP, DBP, MAP), non-invasive blood pressure, SVV, central venous pressure (when available), heart rate, SpO2, PFI, etCO2.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
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
- •Elective open GI surgery
- •Invasive arterial blood pressure monitoring
- •Informed consent
排除标准
- •Significant stenosis > 30% or abnormal anatomy of aortic, femoral, carotid or brachial artery
- •Cerebrovascular accident
- •Atrial fibrillation
- •COPD stage 3-4
- •Lobectomy / pneumectomy
- •Active pneumonia
- •Cardiac failure
- •Severe heart valve regurgitation or stenosis
- •Not able to measure brachial or carotid artery blood flow during surgery
- •Contra-indications for femoral arterial catheter placement (e.g., vascular graft)
结局指标
主要结局
Cardiac output
时间窗: baseline
blood flow determined by ultrasound and the accuracy compared to transpulmonary thermodilution calibrated continuous cardiac output
次要结局
- Cardiac output change(change from baseline cardiac output 1 minute after intervention (fluid challenge, vasopressor administration, or Trendelenburg))
研究者
A.P.J. Vlaar
Principal investigator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
