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临床试验/CTRI/2017/02/007968
CTRI/2017/02/007968已完成不适用

Comparison of success of intubation and laryngeal morbidity in Bougie versus Wire guided intubation

JIPMER1 个研究点 分布在 1 个国家目标入组 104 人开始时间: 2014年11月26日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
JIPMER
入组人数
104
试验地点
1
主要终点
To compare success of intubation and laryngeal morbidity in bougieversus wire guided intubation

研究概览

简要总结

On the day prior to surgery routinepreanesthetic examination with airway assessment will be done. All patientswill any one or more marker of difficult airway like Modified mallampatti score2 or more or mild terminal neck restriction will be taken up for the study. Afterwritten informed consent routine premedication will be given. In the operatingtheatre after attaching standard ASA monitors patients will be positioned insniffing position using a pillow. Following preoxygenation intravenousinduction will be done using fentanyl 2mcg/kg,thiopentone 4-5 mg/kg.Endotracheal intubation will be facilitated using vecuronium 0.1mg/kg andfollowing ventilation with 100% oxygen and sevoflurane for 3 minuteslaryngoscopy will be done. On laryngoscopy the Cormack lehane grade will berecorded and only if it is grade 2 or more the anesthesiologist will intubatewith either bougie or guidewire depending upon the random allocation intoeither of the two groups. In the first group (BG) bougie will be passed throughglottis, scope removed and tube railroaded over it. In the second group (WG)guidewire will be passed through glottis, scope removed and tube railroadedover it. In both the groups time taken for intubation, hemodynamic parametersduring intubation, successful intubation in first attempt  and manipulation needed while railroading thetube will be noted. If intubation fails with either of the two techniquesvideolaryngoscope guided intubation will be done and it will be taken as afailure. In the post operative period within 12 hours of surgery patients willbe assessed by an ENT surgeon using telelaryngoscopy for any laryngealmorbidity and questioned regarding any hoarseness of voice or sore throat orvoice changes.

研究设计

研究类型
Interventional
分配方式
Random Number Table
盲法
Outcome Assessor Blinded

入排标准

年龄范围
20.00 Year(s) 至 65.00 Year(s)(—)
性别
Male

入选标准

  • i.Adults ASA 1-2 ii.Age 20-65 years undergoing surgery under general anesthesia requiring endotracheal intubation.

排除标准

  • i.patients planned for awake fibreoptic intubation ,nasal intubation, ii.
  • Rapid sequence induction.
  • Patients undergoing surgery in prone position or neck surgery.

结局指标

主要结局

To compare success of intubation and laryngeal morbidity in bougieversus wire guided intubation

时间窗: preoperative and within 24 hrs of extubation

次要结局

  • To compare hemodynamic stress response and difficulty in railroading the tube in bougie versus wire guided intubation .(intraoperative only)

研究者

发起方
JIPMER
申办方类型
Research institution and hospital

研究点 (1)

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