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临床试验/NCT04593797
NCT04593797已完成不适用

The Accuracy of Ultrasound Derived Carotid, Femoral and Brachial Artery Compared to Conventional Intra-vascular Methods Flow-related Parameters

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2018年4月19日最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

A.P.J. Vlaar

Principal investigator

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

研究点 (1)

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