Evaluation of an Algorithm for Length Based Weight Estimation in Comparison to Already Known Devices Like the Pediatric Emergency Tape (Pädiatrisches Notfalllineal - PNL)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 492
- 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 pediatric emergency tape (Alpha 1 Werbedesign e.K., Falkenberg, Germany). 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 pediatric emergency tape (53% are in a +/- 10% interval).
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 pediatric emergency tape) will be compared with eachother 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
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
次要结局
- size of endotracheal tube(during anaesthesia)
- size of laryngeal mask(during anaesthesia)
- size of facemask(during anaesthesia)
- length based age estimation(during anaesthesia)
- size of oropharyngeal tube(during anaesthesia)
研究者
Alexander Schmidt
Dr. med.
University Children's Hospital, Zurich