跳至主要内容
临床试验/NCT05220709
NCT05220709招募中不适用

Bio Impedance Monitoring as a Tool to Assess Fluid Status in the Pediatric Surgical Patient: Can we Measure a Fluid Shift

University Hospital, Antwerp2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2022年4月5日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
100
试验地点
2
主要终点
total body water

研究概览

简要总结

The baseline infusion rate during surgery for pediatric patients still is the 'Holliday and Segar' rule (also known as the 4/2/1 rule) The question arises if this rule is not outdated, since it was calculated based on the caloric need of the pediatric population, calculated for cow milk. The study tends to validate the use of bio impedance measurements for registering fluid shifts in the pediatric surgical patients.

详细描述

The Body Composition Monitor (BCM, Fresenius Medical Care, Germany) is the first device that determines individual fluid status and body composition in an easy and objective way. The technology uses bioimpedance spectroscopy (BIS) to determine total body water (TBW) and extracellular water volume (ECW).It measures at 50 frequencies over a range from 5 to 1000 kHz to determine the electrical resistances of the total body water and the extracellular water. While high-frequency current passes through the total body water, low-frequency current cannot penetrate cell membranes and thus flows exclusively through the extracellular water.

To obtain the clinically relevant output parameters, two advanced physiological models are used in the BCM: a volume model, describing electrical conductance in a cell suspension enabling the total body water and extracellular water as well as the intracellular water (ICW) to be calculated, and a body composition model calculating the three principal body compartments overhydration, lean tissue and adipose tissue from ECW and TBW information.

The measurement is a non-invasive and accurate method that is easy to apply and results are obtained within just two minutes. It has been extensively used in patients with kidney disease receiving dialysis, both in adult and pediatric patients. However, bio impedance spectrometry has not yet been tested in the perioperative setting.

This is a single-center pilot study to evaluate if bio impedance measurement is a workable tool to determine fluid shifts in the pediatric population after a surgical procedure was performed under general anesthesia. Patients will be seen preoperatively by an anesthesiologist which is standard of care upon surgery under general anesthesia and eligibility will be evaluated. Informed consent will be asked and has to be signed by the accompanying parent or legal guardian. Where possible, care will be taken to inform the child itself about the content of the study and to get a written acknowledge. There are no other investigations necessary for this research. All patients on the day of surgery will be fasted as by the guidelines of the European Society of Anesthesia. For patients in daycare surgery, measurements with BCM will be performed preoperatively and postoperatively before ending the IV line on the ward. For inpatient hospitalisation, measurements by BCM will be performed preoperatively, postoperatively 6 hours after induction and postoperatively 24 h after induction.. Age, gender, height, weight and blood pressure are registered in the device before starting the measurement. If the quality calculated by BCM is < 60%, the measurement will be repeated again and only good quality measurements will be used.

Data are collected on chip cards by the BCM. Data can be transferred to a personal computer for further analysis with the Fluid Management Tool (FMT). Site requirements is the availability of a low electronic surrounding for correct measurement. After discharge of the hospital no further follow up assessments regarding this study are needed.

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
1 Month 至 16 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Scheduled for elective surgery or investigation under general anesthesia
  • Day care or inpatient hospitalisation

排除标准

  • If sedation is needed instead of general anesthesia
  • Critically ill patients for urgent surgery
  • Patients who cannot lie still for performing correct measurements on the bio impedance monitor
  • No informed consent obtained

研究组 & 干预措施

Bio impedance spectroscopy in children scheduled for elective surgery under general anesthesia

Other

All subjects receive bio impedance monitor measurements pre operatively and post operatively.

干预措施: bio impedance spectroscopy by means of the Body Composition Monitor (Name of the device is BCM from Fresenius Medical Care D GmbH) (Diagnostic Test)

结局指标

主要结局

total body water

时间窗: measurements with BCM will be done within 24 hours post-surgery for hospitalized patients

sum of intracellular water and extracellular water, calculated in liter

次要结局

未报告次要终点

研究者

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

Vera Saldien

Principal Investigator

University Hospital, Antwerp

研究点 (2)

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