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临床试验/NCT03945942
NCT03945942已完成不适用

Influence of Hyperbilirubinaemia on Foresight and INVOS Oximetry Values in Pediatric Hepatic Transplantation

Cliniques universitaires Saint-Luc- Université Catholique de Louvain1 个研究点 分布在 1 个国家目标入组 33 人开始时间: 2019年3月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
33
试验地点
1
主要终点
influence of chromophores such as bilirubin on oximetry values provided by two different devices

研究概览

简要总结

Protocol Near infrared spectroscopy liver transplants: comparison of two monitoring of Near infrared spectroscopy in pediatric liver transplant.

详细描述

Hyperbilirubinaemia may interfere with oximetry values as measured by Near Infrared Spectroscopy devices. The number of wave lengths used by different devices can influence the oximetry values in adult patients. This has never been demonstrated in children with hyperbilirubinaemia scheduled for elective liver transplantation.The study will compare cerebral and somatic oximetry values measured by two different Near infrared spectroscopy devices (FORESIGHT and INVOS) and analyse the influence of bilirubin levels on these differences.

研究设计

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

入排标准

年龄范围
— 至 18 Years(Child, Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Pediatric patients 0 to 18 years, with a liver transplant with living donor program of our institution
  • •Free, informed and written consent signed by the investigator or employees and by the legal guardians of minor patients in the days preceding the procedure

排除标准

  • •refusal of the patient or his parents to consent
  • •known brain or Neurological pathology

研究组 & 干预措施

Pediatric liver transplant patients

Other

Using somatic and cerebral Near infrared spectroscopy devices

干预措施: Near infrared spectroscopy with INVOS device (Device)

Pediatric liver transplant patients

Other

Using somatic and cerebral Near infrared spectroscopy devices

干预措施: Near infrared spectroscopy with Foresight device (Device)

结局指标

主要结局

influence of chromophores such as bilirubin on oximetry values provided by two different devices

时间窗: From Day 0 of surgery until arrival at pediatric intensive care unit (up to 12 hours)

measure of oximetry values by two different devices at different time points in function of serum bilirubin levels

次要结局

未报告次要终点

研究者

发起方
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
申办方类型
Other
责任方
Sponsor

研究点 (1)

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