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临床试验/NCT02620540
NCT02620540已完成不适用

Evaluation of an Algorithm for Length Based Weight Estimation in Comparison to Already Known Devices Like the Broselow Tape (BT)

University Children's Hospital, Zurich1 个研究点 分布在 1 个国家目标入组 312 人开始时间: 2015年11月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
312
试验地点
1
主要终点
length-based weight-estimation by algorithm

研究概览

简要总结

The purpose of this prospective single center study is to investigate if a developed algorithm is more accurate than the Broselow Tape (BT). For this study 500 patients are required to collect anonymized data (length, weight, age, anaesthesia material used during anaesthesia) for achieving a power of 80% during statistical analysis. The main hypothesis ist that the algorithm has a better accuracy than the BT.

详细描述

This prospective single center study is performed at the university children's hospital zurich. Patients planned for surgery in general anaesthesia with intubation, aged 0 to 16 years and with a body length suitable for the emergency tapes can be included in this study. Patient and parental information is performed during the pre-anaesthetic visit.

After written consent the patient will be included. Patient ́s length and weight will be measures earliest one day before data collection. Data collection during anaesthesia has no influence on the daily anaesthesia routine and has no impact on patient safety and anaesthesia. Patient's data is made anonymous for further inspection. Data is documented in Microsoft Excel and statistical analysis calculated with SPSS.

500 patients are needed for a power of 80%. Primary outcome parameter is length- based weight estimation, secondary outcome parameters are length-based age estimation and the correctness of recommended anaesthesia material (endotracheal tube, laryngeal mask, oropharyngeal mask and face mask). Both tools (algorithm and BT) will be compared with each other regarding primary and secondary outcome parameters.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
1 Day 至 16 Years(Child)
性别
All
接受健康志愿者
是

入选标准

  • •body length suitable with the investigated emergency tapes
  • •all patients aged 0 -16 years
  • •receiving general anaesthesia with intubation or laryngeal mask

排除标准

  • •Already included in this study once
  • •missing patient or parental consent

结局指标

主要结局

length-based weight-estimation by algorithm

时间窗: during anaesthesia

The by the algorithm estimated bodyweight based on the patient's Body length is investigated regarding the estimations accuracy and cases in the +/- 10% interval

次要结局

  • size of laryngeal mask(during anaesthesia)
  • size of facemask(during anaesthesia)
  • size of endotracheal tube(during anaesthesia)
  • length based age estimation(during anaesthesia)
  • size of oropharyngeal tube(during anaesthesia)

研究者

发起方
University Children's Hospital, Zurich
申办方类型
Other
责任方
Sponsor

研究点 (1)

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