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临床试验/NCT03248830
NCT03248830已完成不适用

Evaluation of Non-invasive Hemoglobin Monitoring in Children With Congenital Heart Diseases

Cairo University1 个研究点 分布在 1 个国家目标入组 56 人开始时间: 2018年2月20日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
56
试验地点
1
主要终点
non-invasive hemoglobin

研究概览

简要总结

The investigators will evaluate the accuracy of non-invasive hemoglobin monitor (Sp-Hb) compared to traditional laboratory hemoglobin (Lab-Hb) in children with congenital heart disease. The investigators will also compare the accuracy of Sp-Hb in cyanotic children to acyanotic children.

详细描述

Blood hemoglobin is measured daily in clinical practice. Laboratory measurement (Lab-Hb) of is the gold standard for assessment of blood hemoglobin. Recently, non-invasive monitors had been introduced. Non-invasive measurement of hemoglobin (Sp-Hb) would save time and minimize the risk of infection. Blood sampling in children is usually more difficult and stressful; moreover, it also carries the risk of iatrogenic anemia.

Radical-7 (Masimo corporation, Irvine, CA) is a device that operates using the principle of co-oximetry . Radical-7 had been validated in various clinical purposes. Measurement of blood hemoglobin is an important application for Radical-7 device. Non-invasive hemoglobin (Sp-Hb) measurement has been frequently validated in adults; as well as in pediatric patients; however, its accuracy in children with congenital heart disease was not investigated. Congenital heart disease infants usually undergo major operations and frequently need transfusion of blood. Moreover, these patients have special circulatory physiology that might impact the device accuracy. It had been recently reported that the performance of co-oximetry in congenital heart disease children is poor in measurement of oxygen saturation specially at oxygen saturation under 75%; however, its accuracy in measurement of hemoglobin was not investigated yet. In this study, the investigators will evaluate the accuracy of Sp-Hb compared to traditional Lab-Hb in children with congenital heart disease. the investigators will also compare the accuracy of Sp-Hb in cyanotic children to acyanotic children.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
1 Month 至 8 Years(Child)
性别
All
接受健康志愿者

入选标准

  • infants and children less than 8 years
  • with congenital heart disease

排除标准

  • refusal of the patient surrogate to share in the study

结局指标

主要结局

non-invasive hemoglobin

时间窗: 5 hours

the value of hemoglobin measured by radical-7 device in g/dL

次要结局

  • laboratory hemoglobin(5 hours)
  • systolic blood pressure(5 hours)
  • heart rate(5 hours)
  • perfusion index(5 hours)
  • plethysmography variability index(5 hours)
  • diastolic blood pressure(5 hours)
  • oxygen saturation from radical-7 device(5 hours)
  • oxygen saturation from arterial blood gases(5 hours)

研究者

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

Ahmed Hasanin

Assistant professor

Cairo University

研究点 (1)

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