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临床试验/NCT03560895
NCT03560895已完成不适用

Ultrasonographic Prediction of Actual Tube Size and Performance Characteristics of Cuffed Vs Un-Cuffed Endotracheal Tubes in Pediatric Surgical Patients.

Assiut University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2018年6月25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
100
试验地点
1
主要终点
The rate of agreement between the reference tube size based on sonographic measurements and the final BEST-FIT ETT

研究概览

简要总结

The aim of this study will be to test the accuracy of Sonography in determining the endotracheal tube size in pediatric patients whether cuffed or un-cuffed.

详细描述

  • Children's tracheas have traditionally been intubated with un-cuffed tracheal tubes (TT) due to differences between adult and pediatric sub-glottic anatomy and fears that cuffs may lead to mucosal damage and subglottic stenosis. Despite this, cuffed TTs are increasingly used in pediatric anesthesia. Over the last 20 years, evidence suggests that cuffed TT may have advantages over un-cuffed, and are associated with at least similar, if not superior, airway outcomes when compared with un-cuffed TT in children.
  • Formulas based on age and height often fail to reliably predict the proper endotracheal tube (ETT) size in pediatric patients. Visualization of the pediatric subglottic airway diameter by ultrasonography (USG) can enable a practitioner to better predict ETT size, preventing unnecessary tube changes and airway trauma. Also, Visualization of the transvers diameter of epiphyseal end of distal radius by ultrasonography (USG) has been recently investigated and can enable a practitioner to better predict ETT size. Recent reports suggest that the diameter of the subglottic upper airway can be determined by ultrasonography in healthy young adults and pediatric patients . However, the extent to which ultrasonography by these two measurements can predict optimal ETT size in pediatric patients remains under investigation.

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 Year 至 6 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Weight: 10-30 kg.
  • Age: 1-6 years.
  • Sex: both males and females.
  • ASA physical status: I-II.
  • Operation: elective surgery in which airway management with an endotracheal tube is needed.

排除标准

  • Upper airway malformations.
  • Upper airway surgery.
  • Active respiratory illness (cough, fever, rhinorrhea) on the day of anesthesia,
  • Anticipated difficult airway.

结局指标

主要结局

The rate of agreement between the reference tube size based on sonographic measurements and the final BEST-FIT ETT

时间窗: AT induction of anesthesia

The rate of agreement between the reference tube size based on sonographic measurements and the final BEST-FIT ETT

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

Hala Saad Abdel-Ghaffar

Professor of anesthesia and intensive care, faculty of medicine, Assiut university.

Assiut University

研究点 (1)

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