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临床试验/NCT02634099
NCT02634099已完成不适用

Hemoglobin Monitoring During High Bleeding Risk Surgery in Pediatric Patients: Equivalence Study of Hemoglobin Transcutaneous Saturation and Hemocue With Total Serum Hemoglobin

Central Hospital, Nancy, France1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2016年1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
已完成
发起方
入组人数
50
试验地点
1
主要终点
comparison of hemoglobin measurement using 3 different techniques at the time of transfusion decision

研究概览

简要总结

Investigators compare the accuracy of the SpHb and hemocue with blood Hb levels

详细描述

The goal of the study is to compare 3 methods of hemoglobin measurement in pediatric patients undergoing major surgery. During general anesthesia investigators will measure and compare at different periods of time blood hemoglobin levels obtained from a radial artery catheter with 2 non invasive methods of measurement using hemocue and SpHb

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 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Paediatric patients scheduled for major orthopaedi or neurosurgical process under general anesthesia Arterial catheter necessary in the anesthetic protocol. BMI<30 No opposition holders of parental authority and children.

排除标准

  • Hemoglobin disease Pretreatment with erytropoietin or iron

研究组 & 干预措施

hemoglobine monitoring

Other

3 different techniques will be used for hemoglobine monitoring : hemocue, pulse co-oxymeter (SpHb) and blood measurement

干预措施: blood measurement (Device)

hemoglobine monitoring

Other

3 different techniques will be used for hemoglobine monitoring : hemocue, pulse co-oxymeter (SpHb) and blood measurement

干预措施: pulse co-oxymeter (SpHb) (Device)

hemoglobine monitoring

Other

3 different techniques will be used for hemoglobine monitoring : hemocue, pulse co-oxymeter (SpHb) and blood measurement

干预措施: hemoCue (Device)

结局指标

主要结局

comparison of hemoglobin measurement using 3 different techniques at the time of transfusion decision

时间窗: within the day of surgery

comparison of blood hemoglobin obtained by arterial samples with 2 non invasive methods of measurement using hemocue and SpHb

次要结局

未报告次要终点

研究者

发起方
Central Hospital, Nancy, France
申办方类型
Other
责任方
Sponsor

研究点 (1)

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