Validation of Non-invasive Hb-measurement (SpHb) in Children With the Masimo@ Radical 7
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 81
- 试验地点
- 2
- 主要终点
- correlation between SpHb(®) and the Hb measured by the ABL800Flex and the Siemens Advia
研究概览
简要总结
The purpose of this study is to evaluate the value of the new technique of non-invasive measurement of Hb in children undergoing a surgical procedure.
详细描述
Several surgical procedures require haemoglobin monitoring due to possible blood loss and the need of blood transfusion. The standard for monitoring hemoglobin (Hb) is the measurement of blood samples. The novel technique of non-invasive continuous measurement of Hb using Pulse CO-Oximetry may allow measuring Hb without obtaining blood samples.
This new technique has not been tested yet in children undergoing anesthesia for elective surgical procedures. In this study the investigators compare the non-invasive Hb measurement with Masimo® technology (SpHb) with the standard Hb measurement using ABL-800 Flex (BGA) and Siemens Advia (labHb, reference method) before the children undergo the surgical procedure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- — 至 8 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •children (>= 3 kg until 8 years)
- •ASA I-III
- •written informed consent of legal representative
排除标准
- •children <= 3kg or > 8 years
- •emergency surgery
- •allergy against sensor of SpHb(®)
- •artery occlusive disease
- •haemoglobinopathy
- •specific medical or psychological circumstances which do not allow the consent of the legal representative or the performance of the study
结局指标
主要结局
correlation between SpHb(®) and the Hb measured by the ABL800Flex and the Siemens Advia
时间窗: one day
次要结局
- influence of inhalation anesthetics(one day)
研究者
Dr. Eva Wittenmeier
Dr. Eva Wittenmeier
Johannes Gutenberg University Mainz