跳至主要内容
临床试验/CTRI/2011/06/001847
CTRI/2011/06/001847招募中不适用

Validation of Ultrasonography derived formula to predict endotracheal tube size in pediatric patients

Department Of Anaesthesiology and Pain managemenMax Super Speciality Hospital Saket New Delhi1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2011年7月15日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
80
试验地点
1
主要终点
To determine the rate of agreement between the clinically optimal and the predicted endotracheal tube size as determined by the regression formula based on ultrasonography of the paediatric airway

研究概览

简要总结

Determination of appropriate sized endotracheal tube isessential in children.Intubationof pediatric patients with an endotracheal tube (ETT) that is too small mayresult in insufficient ventilation, poor reliability of end-tidal gasmonitoring, leakage of anesthetic gases into the operating room environment,and an enhanced risk of aspiration. In contrast, an ETT that istoo large can cause upper airway damage (e.g., local ischemia, ulceration,scar formation) and the potential for subsequent subglottic stenosis. Age-based formulas are commonly  used toestimate optimal ETT size.  Predictive formulas for appropriate ETTsize have also been based on patient weight and height. However, none of theseformulas are able to determine the appropriate size of the endotracheal tubewith great accuracy. Studieshave shown that agreement rate of these formulas for determining theappropriate endotracheal tube size in paediatric patients is as low as 47-77%.  The result is that repeated laryngoscopiesare often necessary to identify the appropriate tube for individual patients.Recent reports suggest that the diameter of the subglottic upper airway can bedetermined by ultrasonography in young adults and pediatric patients. A new regression formula based on measurement of subglottic diameter byultrasonography has been formulated by Shibasaki et al. Unlike theage based formulas , not many studies have been done to evaluate the  agreement rate of the endotracheal tube sizedetermined clinically  and that determinedby  formula based on ultrasonography.

Inour study we aim to determine the rate of agreement between the clinically optimaland the predicted endotracheal tube size as determined by the regression formula based on ultrasonography of thepaediatric airway

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded

入排标准

年龄范围
1.00 Day(s) 至 10.00 Year(s)(—)
性别
All

入选标准

  • 1.Male or female 2.Age full term neonate to 10 years 3.ASA physical status I-II.

排除标准

  • 1.History or physical evidence of intrinsic or extrinsic airway obstruction 2.History of upper or lower respiratory tract infection 3.Patients requiring nasotracheal intubation 4.Patients requiring intubation with uncuffed endotracheal tube.

结局指标

主要结局

To determine the rate of agreement between the clinically optimal and the predicted endotracheal tube size as determined by the regression formula based on ultrasonography of the paediatric airway

时间窗: From induction of anaesthesia to intubation of trachea with a cuffed endotracheal tube

次要结局

  • To determine the rate of agreement between the clinically optimal and the predicted endotracheal tube size as determined by the age based formula

研究者

发起方
Department Of Anaesthesiology and Pain managemenMax Super Speciality Hospital Saket New Delhi
申办方类型
Research institution and hospital

研究点 (1)

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