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临床试验/CTRI/2021/07/034600
CTRI/2021/07/034600尚未招募不适用

Comparision between Ultrasound Based Technique with Age Based Formula in Prediction of Appropriate Endotracheal Tube Size in Children. "One Year Hospital Based Randomised Control Trial"

YEKKALDEVI MANOGNYA1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2021年12月7日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
50
试验地点
1
主要终点
To compare the Efficiency of ultrasound with age-based formula to estimate the correct size Endotracheal tube in paediatric age

研究概览

简要总结

Methodology:

After obtaining the approval of ethical committee and written informed consent, a total of 50 paediatric patients undergoing surgery under general anesthesia with endotracheal intubation will be included in the study.

After having met inclusion and exclusion criteria, and having obtained informed consent, patients will be randomized based on computer generated randomization table into one of the two groups of 25 each

Group A: (N=25)

Intubated with an Endotracheal tube of the size as determined by the age based formula.

 Group B: (N=25)

Intubated with an Endotracheal tube of the size as determined by ultrasonographic assessment of subglottic diameter. By sonosite M TURBO linear probe of frequency 7-15MHz.

A thorough pre-anesthetic evaluation will be done on the day   before surgery with necessary investigations like complete blood count (CBC), chest X-ray, mini renal profile & liver function test will be done if required

 Child will be kept NBM for at least 6 hours prior to surgery.

On the day of surgery, in the recovery room after confirming the NBM status and consent will be ascertained. Child will be given Inj.Glycopyrrolate (0.005mg/kg) and Inj. Ketamine(5mg/kg) IM and then shifted to operation theatre.

 Inside the operation theatre standard monitoring devices like ECG, pulse oximeter and NIBP will be connected.

Intravenous access will be secured using 22G or 24G IV cannula and IV infusion will be started.

       Group-A: ETT tube size will be estimated by using age based formula

Age/3 + 3.5

In children < 6years -

In children > 6years -  Age/4 + 4.5

Group-B:

ETT tube size will be estimated by measuring the subglottic diameter using high resolution B ultrasonography.

 Â·       Child in supine position with head at neutral position the probe of ultrasonography will be placed in midline.

·       True vocal cords will be localized which can be seen as a pair of hyperechoic linears structure which move along with respiration and swallowing.

·       Then the probe will be moved caudally to visualize the cricoid arch to avoid confusion between the cricoid cartilage and tracheal ring.

·       The measurement of tracheal diameter will be taken as a transverse air column diameter done at cephalic half of the cricoid cartilage which is narrower than the caudal part of cricoid cartilage.

·       Patient will be pre-oxygenated with 100% oxygen for 3 minutes and then premedicated with Inj.Midaz(0.05mg/kg) and Fentanyl (1-2mcg/kg) and induced with Inj.ketamine(1-2mg/kg) and Inj. Scoline(2mg/kg) will be given to achieve skeletal muscle paralysis to facilitate endotracheal intubation.

·       Uncuffed endotracheal tubes will be used.

·       Endo tracheal tube intubation will be done.

The following parameters will be used to assess whether the selected ETT is of an appropriate size :

  • ·       ETT passing smoothly through the glottis
  • No audible leak occurs at 10 to 20 cms of H2O.
  • A square wave capnography on ventilation.
GROUP A

GROUP B

|“Best fit†< Predicted

“Best fit†= Predicted

“Best fit > Predicted

“Best fit†< Predicted

“Best fit†= Predicted

“Best fit†> Predicted

|ESTIMATION OF ENDOTRACHEAL TUBE SIZE BY USING ULTRASONOGRAPHY

|ESTIMATION OF ENDOTRACHEAL TUBE SIZE BY USING AGE BASED FORMULA

Number of tube changes for intubation

Age group (years) 1

2

3

|1 – 2

|2 -3

|3 -4

|4 -5

|5 -6

|6- 7

|7 -8

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Not Applicable

入排标准

年龄范围
1.00 Year(s) 至 8.00 Year(s)(—)
性别
All

入选标准

  • 1.Consent provided by parents and guardians 2.Children aged 1-8 years of age 3.ASA physical status I and II 4.Patients undergoing elective surgeries under general anaesthesia.

排除标准

  • 1.Patients whose parents are not consenting for the study 2.Patients having upper respiratory tract infection, tracheal and laryngeal pathology 3.Patients undergoing emergency surgeries 4.Patients with airway difficulties 5.Previous history of child requiring an exceptionally large or small size tube.

结局指标

主要结局

To compare the Efficiency of ultrasound with age-based formula to estimate the correct size Endotracheal tube in paediatric age

时间窗: 2 minutes of induction

次要结局

  • To Compare number of endotracheal tube changes in two groups(0mins)

研究者

发起方
YEKKALDEVI MANOGNYA
申办方类型
Other [self]

研究点 (1)

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