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临床试验/CTRI/2024/02/062295
CTRI/2024/02/062295已完成不适用

The accuracy of ultrasound to predict endotracheal tube diameter in pediatric population undergoing general anaesthesia when compared to traditional age based formulae. A Prospective Randomized Comparative study

All India Institute of Medical Sciences , Bibinagar.1 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2024年2月10日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
140
试验地点
1
主要终点
Intubation by

研究概览

简要总结

A formula to predict the correct size of the endotracheal tube (ETT) to be used in the paediatric patient was first proposed by Cole in 1957 and this is the most commonly used formula even today. Due to the wide variations in the size of children and the frequent inaccuracy of the calculated ETT size, other complex formulae using multiple variables such as age, height and weight were proposed, but did not gain wide use in clinical practice. Intubation of paediatric patients with an ETT that is too small may result in insufficient ventilation, poor reliability of end-tidal gas monitoring, leakage of anaesthetic gases into the operating room environment, and an enhanced risk of aspiration. In contrast, an ETT that is too large can cause upper airway damage (e.g., laryngeal oedema, stridor, local ischaemia, ulceration, granulation, scar formation) and potential for subsequent subglottic stenosis. Repeated laryngoscopies and reintubations may be needed to identify the appropriately sized tube. Some recent reports suggest that the diameter of the subglottic upper airway can be determined by ultrasound in young adults and paediatric patients.ETT size in paediatric population is traditionally determined by age related formulae. Altogether 22 formulae to estimate appropriate endotracheal tube size for paediatric patients (age 0-12 years) were identified: 12 age-based formulas for tubes without a cuff, 4 height-based formulas for tubes without a cuff, 2 weight-based formulas for tubes without a cuff and one multivariate formula for tubes without a cuff as well as 3 age-based formulas for cuffed endotracheal tubes.

Ultrasound has been used in adults to verify accurate placement of ETT but minimally used in paediatric population. Ultrasound can reliably measure the sub glottic diameter which corresponds to maximum outer diameter of ET tube that can be secured. This will also help in reducing wastage of ET tubes, eventually helping with reducing the economic burden and being environmentally friendly.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
6.00 Month(s) 至 12.00 Year(s)(—)
性别
All

入选标准

  • 1.Age between 6 months to 12 years.
  • 2.Elective surgery requiring General Anaesthesia 3.ASA 1 and 2.

排除标准

  • 1.Patients with development anomalies of face/skull 2.Patients with surgeries for tracheal / laryngeal pathology 3.Emergency surgery 4.Recent Upper Respiratory Tract Infection.

结局指标

主要结局

Intubation by

时间窗: Baseline

1 Age related formula

时间窗: Baseline

2 usg measurement

时间窗: Baseline

次要结局

  • 1 number of endotraceal tubes used / wasted(post laryngoscopy)

研究者

发起方
All India Institute of Medical Sciences , Bibinagar.
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Anish Waghray

All India Institute of Medical Sciences , Bibinagar.

研究点 (1)

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