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临床试验/NCT02826135
NCT02826135已完成不适用

Study on Prediction of Fluid Responsiveness Using an Abdominal Compression-Induced Change of Blood Pressure in Children With Bidirectional Cavopulmonary Shunt or Fontan Pathway

Seoul National University Hospital2 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2016年12月2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
64
试验地点
2
主要终点
Changes in stroke volume index after volume expansion

研究概览

简要总结

The purpose of this study is to evaluate predictability of an abdominal compression-induced change of blood pressure for fluid responsiveness in children with single ventricle (bidirectional cavopulmonary shunt and Fontan tract).

详细描述

The purpose of this study is to evaluate predictability of an abdominal compression-induced change of blood pressure for fluid responsiveness in children with single ventricle (bidirectional cavopulmonary shunt and Fontan tract).

When there are clinical signs of hypovolemia, such as hypotension, decreased urine output or decreased central venous pressure, right upper abdomen is gently compressed for 10 seconds. Changes of blood pressure are continuously recorded during this period. About 3 min later, intravenous colloid fluid 10 mL/kg is infused for 20 min.

To evaluate the change of cardiac output, transesophageal or transthoracic echocardiography is performed before and after fluid administration. In addition, hemodynamic parameters including pulse pressure variation, systolic pressure variation, pleth variability index and central venous pressure are also recorded before and after fluid administration.

Finally, patients will be divided into fluid responder group and non-responder group. If cardiac output measured using echocardiography increases over 15% after fluid administration, the patient is fluid responder. Using ROC curve, diagnostic power of abdominal compression-induced blood pressure change for fluid responsiveness will be evaluated

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
3 Months 至 5 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Pediatric patients undergoing elective surgery, who require invasive blood pressure and central venous pressure monitoring during surgery
  • Patients with bidirectional cavopulmonary shunt or fontan tract

排除标准

  • renal, hepatic and pulmonary disease
  • preoperative infection: increased CPR, WBC over 10,000, and with fever
  • genetic and hematologic disease
  • ventricular dysfunction
  • increased intracranial pressure

结局指标

主要结局

Changes in stroke volume index after volume expansion

时间窗: before and after fluid administration (20 min)

次要结局

  • Changes in pleth variability index after volume expansion(before and after fluid administration (20 min))
  • 3.Changes in respiratory changes of peak aortic blood flow velocities after volume expansion(before and after fluid administration (20 min))

研究者

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

Jin-Tae Kim

Associated professor

Seoul National University Hospital

研究点 (2)

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