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临床试验/CTRI/2016/10/007390
CTRI/2016/10/007390已完成不适用

An observational study of feasibility of tracheal intubation using airtraq in paediatric population

LTMMC and LTMGH1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2015年6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
60
试验地点
1
主要终点
Time to intubation (TTI) in seconds

研究概览

简要总结

After approval from the ethics committee, patients in the age group of 3 months to 18 years scheduled for routine surgical procedure under general anaesthesia with endotracheal intubation using airtraq (AT) will be observed during the period of the study. Any co-existing medical disease, associated congenital anomalies and airway problems and will be noted. Written valid informed consent will be taken from the respective parent or guardian. If the child can understand the nature of procedure, he or she will be explained about the study and assent will be taken.

All children will receive general anaesthesia as per routine protocol followed in various operation theatres in LTMGH, Sion. This usually comprises of:

  • Preoperative starvation as per ASA fasting guidelines 2011
  • Establishment of monitoring like electrocardiogram, pulse oximetry, capnography and non invasive blood pressure measurement
  • Premedication in form of antisialogogue, sedatives and analgesic
  • Either Intravenous or Inhalational induction
  • Checking of adequate depth of anaesthesia
  • Confirmation of adequacy of ventilation without gastric insufflation
  • Administration of neuromuscular blockade
  • Intubation using AT laryngoscope by experienced anaesthesiologists as per manufacturer’s instructions (appendix B)
  • Sizes of AT laryngoscope used ( appendix C)
  • Confirmation of proper endotracheal intubation by observation of chest expansion, auscultation of bilateral breath sounds and square wave capnogram

Following parameters will be assessed

**1.**Percentage of glottis opening (POGO) score:  denotes visual estimation of laryngeal opening in score of 0% to 100%. (appendix A)

A POGO score of 100 = full visualisation of larynx from the interarytenoid notch to anterior commissure of the vocal cords; 0 = none of the glottis opening is seen.

2Visual analogue scores (VAS) for field of view :  0 to 10 -point scale. 0 = poor, 10 = excellent

**3.**Time to best view (TTBV):  time interval between blade entry past the lips and the laryngoscopist’s verbal declaration that the best view for endotracheal intubation is achieved.

**4.**Time to intubation (TTI): time interval between blade entry past the lips and the  appearance of first upstroke of the end-tidal CO2 tracing.

**5.**Visual Analogue Scale(VAS) for ease of use : 0 to 10 -point scale. 0 = poor, 10 = excellent

Failed attempts, if any will be noted.

Failed attempt is considered when:

  1. Inability to pass endotracheal tube within 60 seconds of AT blade entry past the lips
  2. Abandoning the intubation attempt due to decrease in oxygen saturation < 94%
  3. Change of premounted endotracheal tube

In our set up more than two intubation attempts with any device are not allowed.

 Failed intubation is considered when successful intubation with airtraq is not possible.

 Difficulties encountered e.g. anterior or posterior impingement of ET tube; loss of visualization due to “fogging†or “red-out†will be noted.

Optimization manoeuvres required (if any) will be noted.

Commonly used optimization manoeuvres are:

·         repositioning the head or the need for a second assistant to aid tracheal intubation

·         use of external laryngeal manipulation

Complications associated with laryngoscopy-intubation, if any will be noted

 STATISTICAL ANALYSIS

Data which are normally distributed will be presented as means ± standard deviation (M ± SD) for continuous variables. Data which is not normally distributed will be presented as median with interquartile range (median with IQR).

A subgroup analysis will be done depending on the size of the AT used. Any difference between the parameters will be studied using ANOVA test. Any significant difference in the parameters in individual group will be compared using unpaired t test. Categorical data like failed attempts, difficulties encountered in each subgroup will be studied by using Chi square test or Fisher’s exact test.

研究设计

研究类型
Observational

入排标准

年龄范围
3.00 Month(s) 至 18.00 Year(s)(—)
性别
All

入选标准

  • American Sosciety of Anaesthesiologists I and II
  • Patients undergoing general anaesthesia with endotracheal intubation using airtraq.

排除标准

  • Difficult airway or history of difficult intubation
  • Risk of gastric aspiration
  • Active upper or lower respiratory tract infection
  • Severely raised intracranial tension
  • Cyanotic heart disease
  • Non consenting parent.

结局指标

主要结局

Time to intubation (TTI) in seconds

时间窗: Time to intubation : Time interval between blade entry past the lips and the appearance of first upstroke of the end-tidal CO2 tracing

次要结局

  • 1.Percentage of glottis opening (POGO) score %(2.Visual analogue scores (VAS) for field of view)

研究者

发起方
LTMMC and LTMGH
申办方类型
Research institution and hospital

研究点 (1)

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