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临床试验/NCT02484365
NCT02484365Unknown不适用

The Accuracy of the Noninvasive Hemoglobin Monitoring for Preoperative Evaluation for Pediatric Patients

Chung-Ang University Hosptial, Chung-Ang University College of Medicine1 个研究点 分布在 1 个国家目标入组 177 人开始时间: 2014年12月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
177
试验地点
1
主要终点
hemoglobin

研究概览

简要总结

The preoperative evaluation including sampling blood in pediatric patients is hard to perform. However, the knowledge of the baseline cell blood count is important to prepare unexpected surgical bleeding etc.. The invasive procedure for blood sampling in small children is often failed and sometimes induces iatrogenic blood loss and parent's complaints. The Pulse Co-oximetry (Masimo) is recently developed device which can provide noninvasive hemoglobin value. However, the accuracy is controversial. There are studies in pediatric patients during surgery and in ICU. However, the comparison for preoperative evaluation is not analysed. Therefore, the investigators want to evaluate the accuracy for preoperative preparation in pediatric patients.

详细描述

There are not enough data comparing the noninvasive hemoglobin and venous hemoglobin in pediatric patients during preoperative period. The investigators will collect the venous sample and the noninvasive hemoglobin data from masimo within 1 hour. Without any additional medication, the patients will visit preanesthetic room and attach the probe of masimo on index finger. The R 20L or R25L will be used based on their weight. The parameter will be stabilized within 2 minutes and the SpHb and perfusion index will be recorded.

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 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • ASA class 1,2

排除标准

  • Poor peripheral circulation
  • Infection or trauma on the sensor contact region

结局指标

主要结局

hemoglobin

时间窗: once, preoperative visit anesthetic office

no F/U is needed

次要结局

未报告次要终点

研究者

发起方
Chung-Ang University Hosptial, Chung-Ang University College of Medicine
申办方类型
Other
责任方
Principal Investigator
主要研究者

Yong-Hee Park

Assistant professor

Chung-Ang University Hosptial, Chung-Ang University College of Medicine

研究点 (1)

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