跳至主要内容
临床试验/CTRI/2021/06/034018
CTRI/2021/06/034018已完成不适用

A RANDOMISED STUDY TO COMPARE C-MAC D BLADE VIDEOLARYNGOSCOPE WITH McCOY DIRECT LARYNGOSCOPE FOR INTUBATION IN CHILDREN UNDERGOING SURGERIES UNDER GENERAL ANAESTHESIA

Chacha Nehru Bal Chikitsalaya1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2021年8月6日最近更新:

试验速览

阶段
不适用
状态
已完成
入组人数
70
试验地点
1
主要终点
Intubation Difficulty Score

研究概览

简要总结

INTRODUCTION: Pediatric airway is not a miniature replica of adult airway and presents unique challenges to anaesthesiologist. C-MAC and McCoy laryngoscopes have been well validated for routine and difficult airway in adult patients, but there is limited data available for their efficacy in pediatric airway management. Hence, we propose this study to compare the performance of C-MAC videolaryngoscope with PEDD blade and McCoy laryngoscope in pediatric airway management.

AIM OF THE STUDY: To compare the C-MAC D blade videolaryngoscope with McCoy direct laryngoscope for intubation in children.

OBJECTIVES

PRIMARY OBJECTIVES

  1. To compare the ease of intubation (Intubation Difficulty Scale)

SECONDARY OBJECTIVES

1. To compare visualisation of glottic inlet (Modified Cormack and Lehane grading)

2.     To compare the duration of laryngoscopy

3.      To compare the duration of intubation

To To compare the duration of process of intubation

4.     To compare hemodynamic responses

MATERIAL AND METHODS

•Study Design: Prospective, Randomized Study

• Study Period: March 2021 to October 2021

•Place of study: Department of Anaesthesia, Chacha Nehru Bal Chikitsalya, New Delhi

·       Inclusion criteria:

1.     Patients aged between 4 – 12 years

2.     ASA 1 and ASA 2 patients

3.     Patients undergoing elective surgery requiring general anaesthesia and endotracheal intubation

·       Exclusion criteria

1.     Patients with anticipated difficult airway

2.     Children having severe cardiac or respiratory disease

3.     Children with metabolic disease

4.     Children having reactive airway disease

5.     Children having mental retardation or developmental delay

Outcome Measures:

Primary Outcomes

1.     Intubation Difficulty Scale

Secondary Outcomes

1.     Modified Cormack and Lehane grading

2.     Time to best glottic view (time from insertion of laryngoscope blade between the teeth till the best possible view of vocal cords)

3.     Time to intubate (time from best glottic view till passage of ETT through vocal cords)

4.     Total duration of intubation (sum of duration of laryngoscopy and duration of intubation)

5.     Hemodynamic measurements (Heart rate, systolic BP, diastolic BP, mean arterial BP and SpO2 will be recorded at baseline and at 1st min, 3rd min, 5th min and 10th min of intubation.)

  1. any incidence of airway complication.

Methodology: 70 patients of ASA physical status 1 and 2 scheduled for elective surgeries under GA with endotracheal intubation will be randomised and allocated into one of the two groups; each having 35 patients.

Statistical Tests:

Statistical analysis will be performed by the SPSS program for Windows, version 17.0(SPSS, Chicago, Illinois). Continuous variables will be presented as mean ± SD, and categorical variables will be presented as absolute numbers and percentage. Data will be checked for normality before statistical analysis. Normally distributed continuous variables will be compared using the unpaired t test, whereas the Mann-Whitney U test will be used for those variables that are not normally distributed. Categorical variables will be analyzed using either the chi square test or Fisher’s exact test. P<0.05 will be considered statistically significant.

研究设计

研究类型
Interventional

入排标准

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

入选标准

  • ASA class 1 and 2.

排除标准

  • 1.Patients with anticipated difficult airway 2.Children with known metabolic disease 3.Children having reactive airway disease 4.Known case of Mental retardation or developmental delay.

结局指标

主要结局

Intubation Difficulty Score

时间窗: 0 min

次要结局

  • 1.Modified Cormack and Lehane grading(0 minute at the time of laryngoscopy)
  • 2.Time to best glottic view(0 minute)
  • 3.Time to intubate(0 minute just after intubation)
  • 4.Total duration of procedure of intubation(0 minute)
  • 5.Hemodynamic measurements (Heart rate, systolic BP, diastolic BP, mean arterial BP and SpO2 will be recorded at baseline and at 1st min, 3rd min, 5th min and 10th min of intubation.)(Baseline,1minute, 3rd minute, 5th minute and 10th minute after intubation)

研究者

申办方类型
Research institution and hospital

研究点 (1)

Loading locations...

相似试验