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临床试验/CTRI/2014/09/004960
CTRI/2014/09/004960进行中(未招募)不适用

PROSPECTIVE RANDOMIZED CROSSOVER COMPARATIVE STUDY OF DIRECT LARYNGOSCOPIC VIEW IN SNIFFING AND 25 DEGREES BACKUP POSITION

Jaslok Hospital and Research Centre1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2014年4月3日最近更新:

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
100
试验地点
1
主要终点
laryngeal view (Modified Cormack Lehane Grade) during direct larngoscopy (L1 and L2) in sniffing and 25 degrees back up position

研究概览

简要总结

Withthis study we want to evaluate whether laryngoscopic view is better in 25degrees back up position as compared to sniffing position?  B. J. Lee et al in2007 have shown that during laryngoscopy, the laryngeal view, as assessed byPercentage of glottis opening (POGO) scores, improves significantly in the 25degrees back-up position when compared with the flat supine position.However 25 degrees back-up position has not been compared with the sniffingposition which is standard of care for direct laryngoscopy. The aim ofthis study is to evaluate the effect of 25 degree back up position on laryngealview compared with the sniffing position during direct laryngoscopy. Theprimary objective is to compare the laryngeal view in both positions by bymodified Cormack – Lehane grading.  Secondary Objectives are to compare thelaryngeal view in both positions after applying external laryngeal  pressure if necessary, to compare thedifficulty in intubation with the help of Intubation Difficulty Scale(IDS)and to find out the mode value ofpillow height required to achieve optimal sniffing ( external auditory meatusto sternal notch ) position. 100 adult patients ASA I, II and III physicalstatus posted for surgery under general anaesthesia with endotrachealintubation will be studied. A detailed preanaesthetic evaluation of airway willbe performed which includes BMI, thyromental distance, interincisor gap andmodified Mallampatti grading, and adequacy of neck movement.Patients will be randomized as Group S where intubation will be done insniffing position and Group B where intubation will be done in 25 degreesbackup position. Laryngoscopy will be performed in both positions in eachpatient followed by endotracheal intubation. Glottic visualization will beassessed by modified Cormack Lehane classification. IntubationDifficulty Scale (IDS) will assess the intubation difficulty.

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
18.00 Year(s) 至 90.00 Year(s)(—)
性别
All

入选标准

  • 1.Patients scheduled to receive General Anaesthesia with endotracheal intubation.
  • 2.ASA Grade I, II and III 3.Malampatti Classification I, II, III 4.Body Mass Index ( BMI) < 35 Kg/m2 5.Patients giving informed consent.

排除标准

  • 1.Patients refusal 2.ASA Grade IV.
  • Anticipated difficult airway.
  • 5.Patients with loose teeth 6.Body mass index more than 35 Kg/m2 7.Patients with cervical spine disease
  • Condition requiring rapid sequence intubation.
  • 9.Patients with severe cardiovascular disease.
  • 10.Coagulopathy or patient on anticoagulant therapy.
  • Raised intracranial tension.
  • 12.Pregnant females.

结局指标

主要结局

laryngeal view (Modified Cormack Lehane Grade) during direct larngoscopy (L1 and L2) in sniffing and 25 degrees back up position

时间窗: at the end of laryngoscopy

次要结局

  • Pillow height required to achieve optimal sniffing (external auditory meatus to sternal notch) position.
  • Intubation Difficulty Scale(after intubation)

研究者

申办方类型
Research institution and hospital

研究点 (1)

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