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临床试验/NCT04869410
NCT04869410已完成不适用

Accuracy of Broselow Tape and Cole Formulation in Predicting Uncuffed Endotracheal Tube Size in Pediatric Patients

Indonesia University2 个研究点 分布在 1 个国家目标入组 110 人开始时间: 2018年8月15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
110
试验地点
2
主要终点
Appropriate size of uncuffed endotracheal tube

研究概览

简要总结

This study aimed to determine the accuracy of modified Broselow tape measurements compared to Cole formula in predicting the size of uncuffed endotracheal tubes in Indonesian pediatrics

详细描述

110 subjects were given informed consent before enrolling the study and randomized into two groups, modified Broselow Tape and Cole formula. Preoperatively, prediction of suitable ETT size was performed based on Cole formula and Modified Broselow Tape. In the operating theatre, general anesthesia induction was performed with sevoflurane 4-8 vol%, fentanyl 2 μcg/kg BW, and atracurium 0.5 mg/kg BW. Laryngoscopy was performed, and an uncuffed polyvinyl chloride endotracheal tubes, whose size was based on the Cole formula, was inserted. An appropriate size of the endotracheal tube was confirmed if the endotracheal tube could go through the cricoid ring smoothly, and no air leakage found when ventilating with an inspiratory pressure of 15-20 cmH2O. The surgery and anesthesia would proceed if the correct size of the endotracheal tube were successfully inserted. If the tube couldn't pass the cricoid smoothly or air leakage was found when ventilated with an inspiratory pressure of 15-20 cmH2O, the endotracheal tube should be replaced with a bigger or smaller size.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Single (Investigator)

盲法说明

Investigator

入排标准

年龄范围
1 Year 至 6 Years(Child)
性别
All
接受健康志愿者

入选标准

  • pediatrics aged 1 - 6 y o
  • patients went through elective surgery with Genaral anesthesia
  • Need to intubated with uncuffed ETT

排除标准

  • patients with growth and development disorders
  • patients whom height that was out of range in modified Broselow tape
  • patients with possible airway difficulty or obstruction
  • patients with respiratory diseases, underweight and obese

结局指标

主要结局

Appropriate size of uncuffed endotracheal tube

时间窗: before procedure

endotracheal tube could go through the cricoid ring smoothly, and no air leakage found when ventilating with an inspiratory pressure of 15-20 cmH2O

次要结局

未报告次要终点

研究者

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

Aida Rosita Tantri

Doctor

Indonesia University

研究点 (2)

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