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临床试验/NCT02754531
NCT02754531已完成不适用

Comparison Between Ultrasonography and Cole Formula in Predicting Uncuffed Endotracheal Tube Diameter

Indonesia University2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2016年5月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
2
主要终点
The accuracy proportion of USG and Cole Formula

研究概览

简要总结

This study aims to compare the accuracy of measurement between ultrasonography and Cole formula in predicting uncuffed endotracheal tube diameter.

详细描述

Approval from Ethical Committee of Faculty of Medicine Universitas Indonesia was acquired prior conducting the study. Subjects were given informed consent before enrolling the study. Non-invasive blood pressure (NIBP) monitor, ECG and pulse-oximeter was set on the subjects in the operation room. The uncuffed endotracheal tube (ETT) diameter predictions were measured firstly using ultrasonography (USG), then with Cole formula. After that, polyvinyl chloride (Mallinckrodt) ETT intubation with Cole diameter measurement was inserted using direct laryngoscopy. If the ETT was too small, use a 0.5 mm bigger ETT than the prediction diameter, if it too big, use a 0.5 mm smaller ETT than the prediction diameter. Reintubation and measurements using both methods were recorded. If bradycardia or desaturation happened, positive pressure ventilation, 100% oxygen, atropine 0,01-0,02 mg/kg, adrenaline 0,01 mg/kg could be given. Data was analyzed using SPSS using Bivariat Chi-square test or Fisher Exact Test (categorical comparative analytical study).

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
盲法
None

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

  • Subjects aged 1-6 years old, Malayan race, planned to undergo elective surgery with general anesthesia with intubation
  • Subjects with ASA status I-II
  • Cooperative subjects
  • Subjects whose parents had signed the informed consent

排除标准

  • Subjects with allergies to Ultrasonography jelly
  • Subjects with difficult airway
  • Subjects with mass in the neck area
  • Subjects with respiratory diseases
  • Subjects with growth & development disorders
  • Subjects with malnutrition (<5% percentile) and obesity (>95% percentile).
  • Drop out criteria:
  • Subjects with cardiorespiratory disorder during intubation
  • Subjects who were failed to be intubated twice.

结局指标

主要结局

The accuracy proportion of USG and Cole Formula

时间窗: 3 months

Whether the USG measurement and Cole Formula measurement accurate or not will be recorded.

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

Dr. dr. Aida Rosita Tantri SpAn-KA

Consultant, Anesthesiologist

Indonesia University

研究点 (2)

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