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临床试验/NCT04463082
NCT04463082已完成不适用

Assessment of the Current State of Volume Status in Children by Ultrasound Measurement of Vena Cava Inferior and Vena Jugularis Interna Combined With Passive Leg Raise: a Pilot Study

University Hospital Ostrava2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2020年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
30
试验地点
2
主要终点
Change in vena jugularis interna diameter pre- and post-hydration (on the right side)

研究概览

简要总结

Children with clinical signs of severe dehydration will be examined by ultrasound in a supine position during admission. Children aged between 1 and 15years will be divided into three weight groups: 10-20kg, 20-30kg, 30-50kg. Early after admission 1st measurement of diameters of vena cava inferior (VCImax, VCImin) during breathing cycles and diameters of both venae jugulares (VJI dx max, min, VJI sin max, min) before and after passive leg raise maneuver will be recorded. After a defined fluid infusion within 60 minutes, a second examination will be evaluated and compared with the first one. The investigators considered also echocardiography to measure CO changes however they wanted to make it as simple as it might be at emergency during the night shift without an experienced cardiologist.

详细描述

Only children admitted to the hospital with clinically detectable dehydration (weight loss, dry skin, sunken eyes, no tears) will be evaluated. Weight, noninvasive blood pressure measurement, pulse rate will be recorded. Measurements would be performed with an ultrasound probe with a low frequency (2-5 MHz), a curved array transducer will be used. In the supine position, the ultrasound probe will be placed in the substernal area, in the longitudinal and transversal plane, 1 cm caudal to the confluence of the hepatic veins, and it will be operated in M-mode. The largest (VCImax) and smallest (VCImin) diameters will be measured and the collapsibility index will be calculated (according to the formula: VCImax - VCI min / VCI max x100). Immediately after this examination measurement of the right VJImax, min and the left VJImax, min will be measured again in the supine position, then after passive leg raise (lifting the lower limbs 45st. for at least 1minute ) VJImax, min. and left VJImax, min will be measured. The collapsibility index for right and left VJI would be calculated according to the formula: VJImax - VJI min / VJI max x100. After a defined fluid infusion (20ml/kg, but the maximum volume will be limited to 500ml, this means that over 25kg weight we would apply not more than 500ml) within 60 minutes. A control examination of VCI, right VJI, and left VJI will be evaluated the same way as first and compared with the previous one.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
1 Year 至 15 Years(Child)
性别
All
接受健康志愿者

入选标准

  • previously healthy children
  • history and clinical signs of dehydration (gastroenteritis, diabetic ketoacidosis)

排除标准

  • congenital heart diseases
  • intestinal obstruction
  • any signs of abdominal hypertension
  • any illnesses known to affect the volume status

结局指标

主要结局

Change in vena jugularis interna diameter pre- and post-hydration (on the right side)

时间窗: 60 minutes

Change in vena jugularis interna diameter (in millimetres) will be measured before and after hydration (on the right side).

Change in vena jugularis interna diameter pre- and post-hydration (on the left side)

时间窗: 60 minutes

Change in vena jugularis interna diameter (in millimetres) will be measured before and after hydration (on the left side).

Change in vena cava inferior diameter pre- and post-hydration

时间窗: 60 minutes

Change in vena cava inferior diameter (in millimetres) will be measured before and after hydration.

Change in collapsibility index pre- and post-hydration

时间窗: 60 minutes

Change in collapsibility index values (in per cent) will be measured before and after hydration.

次要结局

  • Correlation to body surface area(60 minutes)

研究者

发起方
University Hospital Ostrava
申办方类型
Other
责任方
Sponsor

研究点 (2)

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