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Comparison of Miller's Blade and Airtraq Laryngoscope in Children

2016年2月11日 更新者：Bikramjit Das、Government Medical College, Haldwani

A Comparative Evaluation of Airtraq Optical LaryngoscopeTM and Miller Blade in Pediatric Patients Undergoing Elective Surgery Requiring Tracheal Intubation.

The Airtraq optical laryngoscope has recently been available in pediatric sizes. The investigators compared the efficacy of Airtraq with the Miller laryngoscope as intubation devices in paediatric patients. This prospective, randomized study was conducted in a tertiary care teaching hospital. Sixty American Society of Anesthesiologists (ASA) grade I-II paediatric patients of 2-10 years, posted for routine surgery requiring tracheal intubation were randomly allocated to undergo intubation using a Miller (n = 30) or Airtraq (n = 30) laryngoscope. The primary outcome measures were time of intubation, ease of intubation, number of attempts and POGO score. We also measured hemodynamic changes and airway trauma.

研究概览

地位

完全的

条件

干预/治疗

详细说明

After approval from the institutional Ethical Committee, 60 patients were studied. A randomised prospective study was planned to compare size 1 Airtraq (Prodol Meditec S.A., Vizcaya, Spain) with Miller blade of same size.

The children included in the study were 2-10 years of age, American Society of Anesthesiologists (ASA) physical status I-II and posted for elective surgeries requiring tracheal intubation. The following were excluded from the study: (i) patients with upper respiratory tract symptoms, (ii) those at risk of gastroesophageal regurgitation and (iii) those with airway-related conditions such a trismus, limited mouth opening, trauma or mass. Sixty patients were equally randomized to one of the two groups (Airtraq and Miller) of 30 each for airway management using a computer-generated randomization program.

Written informed consent was taken from the parents prior to intervention and a standardized protocol for anesthesia was maintained for all cases. All the children were kept nil per mouth as per standard guidelines. Intubation attempts were taken using Airtraq or Miller on a random basis.

研究类型

介入性

注册 (实际的)

60

阶段

  • 不适用

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

2年 至 10年 (孩子)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  1. American Society of Anesthesiologists physical status I-II,
  2. elective surgeries requiring tracheal intubation

Exclusion Criteria:

  1. patients with upper respiratory tract symptoms,
  2. those at risk of gastroesophageal regurgitation and
  3. those with airway-related conditions such a trismus, limited mouth opening, trauma or mass.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：双倍的

武器和干预

参与者组/臂
干预/治疗
有源比较器：Intubation with Miller's blade
After induction and muscle paralysis, Miller's blade was introduced in the patient's mouth. After visualization of vocal cord, patient was intubated with appropriate sized tracheal tube.
设备：Intubation with Miller's blade
Intubation is insertion of a hollow tube inside the trachea. It is done after laryngoscopy with Miller's blade.
实验性的：Intubation with Airtraq laryngoscope
After induction and muscle paralysis, Airtraq laryngoscope's blade was introduced in the patient's mouth. After visualization of vocal cord as a reflected image in the viewfinder of the device, patient was intubated with appropriate sized tracheal tube.
设备：Intubation with Airtraq
Intubation is insertion of a hollow tube inside the trachea. It is done after laryngoscopy with Airtraq.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Time to Intubation
大体时间：5 minutes
It is defined as the time from placement of Airtraq or Miller laryngoscope into the mouth till appearance of the capnograph waveform
5 minutes

次要结果测量

结果测量
措施说明
大体时间
Number of Intubation in First Attempts;
大体时间：5 minutes
A single insertion of the Airtraq or a single insertion of the Miller laryngoscope blade into the mouth with passing the endotracheal tube beyond the glottis was considered as an attempt.
5 minutes
Ease of Intubation.
大体时间：5 minutes
The intubating anaesthesiologist graded the ease of intubation for both techniques on a visual analogue scale from 1 to 10, 10 being most difficult or failed intubation and 1 being very easy intubation.
5 minutes
Percentage of Glottic Opening Scoring.
大体时间：5 minutes
The Percentage of glottic opening score represents the percentage of glottic opening seen, defined by the linear span from the anterior commissure to the interarytenoid notch
5 minutes
Overall Intubation Success Rate.
大体时间：5 minutes
It is the number of participants who were successfully intubated after first, second or third attempts. Success of intubation is defined as placement of endotracheal tube inside the trachea, confirmed by bilateral chest auscultation and square wave capnograph tracing.
5 minutes
Number of Esophageal Intubation.
大体时间：5 minutes
Insertion of tracheal tube inside the esophagus
5 minutes
Number of Participants With Airway Trauma
大体时间：5 minutes
Airway trauma was defined as blood detected on the blades of laryngoscopes, blood on endotracheal tube after extubation or tongue-lip-dental trauma.
5 minutes

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Government Medical College, Haldwani

调查人员

  • 研究主任：Shahin N Jamil, M.D.、J.N.Medical College, Aligarh Muslim University

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

有用的网址

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2013年5月1日

初级完成 (实际的)

2014年5月1日

研究完成 (实际的)

2014年5月1日

研究注册日期

首次提交

2015年3月29日

首先提交符合 QC 标准的

2015年4月21日

首次发布 (估计)

2015年4月22日

研究记录更新

最后更新发布 (估计)

2016年3月9日

上次提交的符合 QC 标准的更新

2016年2月11日

最后验证

2016年2月1日

更多信息

与本研究相关的术语

其他研究编号

  • DN 182/FM

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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