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临床试验/NCT02930928
NCT02930928已完成不适用

Evaluation of an Algorithm for Gender Specific and Habitus Adapted Length Based Body Weight Estimation in Children - Improvement by Adding Another Parameter?

University Children's Hospital, Zurich1 个研究点 分布在 1 个国家目标入组 495 人开始时间: 2016年10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
495
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 the accuracy of length based body weight estimation by the already investigated algorithm (CLAWAR) can be improved by adding another parameter. For this study 500 patients are required to collect anonymized data (length, weight, age, mid upperarm circumference and patient habitus by visual estimation) for achieving a power of 80% during statistical analysis. The main hypothesis ist that CLAWAR's accuracy can be improved.

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 CLAWAR. 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 the accuracy of length based weight estimation using either patient habitus by visual estimation or an improved version of the algorithm CLAWAR using the mid upperarm circumference.

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 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 algorithm
  • •all patients aged 0 -16 years

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 procedure

Habitus adapted weight estimation based on visual habitus classification compared to weight estimation by the modified algorithm CLAWAR utilizing mid upperarm circumference

次要结局

未报告次要终点

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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