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临床试验/NCT03713385
NCT03713385Unknown不适用

Comparison Between the Subglotic Diameter and the Epiphyseal Diameter of the Radius in Children for Prediction of Appropriate Endotracheal Tube Sizes

Mansoura University1 个研究点 分布在 1 个国家目标入组 147 人开始时间: 2018年10月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
147
试验地点
1
主要终点
number of the optimum tube size

研究概览

简要总结

Background: In pediatric anesthesia, selection of the appropriate endotracheal tube (ETT) size is an important task because the inappropriate one may lead to much complication. The aim of this study is to compare between the subglotic diameter and the epiphysis diameter of radius measured by ultrasonography for prediction of optimum endotracheal tube size in children.

Methods: Patients aged from 1 to 6 years will be scheduled for elective surgery under general anesthesia and intubation, were enrolled in this study. Patients were randomly divided into three groups according to method of choosing the tube size.

Aged group (n =49): determined the optimal endotracheal tube size according to age of the child (internal diameter [ID] in mm = [age in years + 16] /4) suggested by Cole.4 Subglottic diameter group (n =49): The subglottic transverse diameter was estimated with ultrasonography on the middle of the anterior region of the neck at the level of cricoid cartilage.

Epiphyseal diameter group (n =49): the epiphyseal transverse diameter of the distal radius was estimated with ultrasonography.

Patient descriptive data, size of the selected ETT, number and size of the optimum tube, number of re-intubation due to incorrect size of ETT either smaller or larger were recorded. Subglottic transverse diameter (mm) and time of intubation were measured. After intubation, pulse, respiratory rate, arterial blood saturation, capnograghy and airway pressure were recorded during surgery.

Any airway complications after extubation as edema, stenosis or stridor were also recorded.

详细描述

Introduction:

In pediatric anesthesia, selection of the appropriate endotracheal tube (ETT) size is an important task because the inappropriate one may lead to much complication. Oversized tubes cause airway edema, post- extubation stridor, subglottic stenosis, or cartilaginous ischemia, smaller ones increase the resistance to gas flow and risk of aspiration, insufficient ventilation, and poor monitoring of end tidal gases.Therefore, many methods have been suggested recently to precisely predict the optimal size of ETT in children to avoid any harmful complication.

Most of the anesthesiologists choose the appropriate ETT size by using calculating formulae which are based on the children's descriptive data such as weight, height or age. The Cole's equation (internal diameter [ID] in mm = [age in years + 16] / 4) is still considered as one of the prevalent methods in spite of its poor prediction power.

Bone and cartilage growth of the body are supposed to be related to each other, therefore some measurements of body growth as bony cartilage growth of the hand are worthy of attention as a marker of tracheal diameter specially bone measurements for the hand is generally accepted as the indicator of growth.

Also, the transverse diameter or width of the child's fifth fingernail has been used to select the size of ETT. However, a few reports have stated that it is unreliable method to predict the correct tube.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

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

  • Patients aged from 1 to 6 years
  • scheduled for elective surgery under general anesthesia and intubation

排除标准

  • Patients refusal
  • An anticipated difficult airway,
  • Any respiratory disease that might cause airway narrowing
  • Pre-exiting laryngeal or tracheal pathology
  • Any lesion that could cause airway deformity due to fibrosis or the presence of a neck anatomical pathologies that could affect the ultrasound evaluation of the airway
  • Any abnormality in the wrist and radius bone
  • Any disease after epiphyseal diameter as Rickets or skeletal dysplasia
  • Prolonged surgery more than 90 minutes

结局指标

主要结局

number of the optimum tube size

时间窗: 3 months

number of the optimum tube size used in pediatric patients in each group

次要结局

  • number of re-intubation(3 months)

研究者

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

Nevert Adel

lecturer of anesthesia, surgical ICU and pain management

Mansoura University

研究点 (1)

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