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临床试验/CTRI/2018/05/013598
CTRI/2018/05/013598招募中Unknown

Comparative evaluation of a videolaryngoscope with a direct laryngoscope for tracheal intubation with manual in line stabilization of neck in patients undergoing cervical spine surgery

Vardhman Mahavir Medical College and Safdarjung Hospital1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2017年6月11日最近更新:

试验速览

阶段
Unknown
状态
招募中
发起方
入组人数
60
试验地点
1
主要终点
To compare Intubation difficulty scale score with C-MAC D-blade videolaryngoscope and McCoy laryngoscope for tracheal intubation with manual in line stabilization of neck in the study population

研究概览

简要总结

PRIMARY OBJECTIVE

To compare intubation difficulty scale score with C-MAC D-blade videolaryngoscope and McCoy laryngoscope for tracheal intubation with manual in line stabilization of neck  in the study population.

SECONDARY OBJECTIVES

To compare total time taken to secure the airway, number of intubation attempts, ease of insertion of the laryngoscope and percentage of glottic opening score  with C-MAC D-blade videolaryngoscope  and McCoy laryngoscope in the study population.

HYPOTHESIS

C-MAC D-blade videolaryngoscope will provide better glottic visualization and decrease intubation difficulty as compared to McCoy laryngoscope in patients with cervical spine immobilization.

研究设计

研究类型
Interventional
分配方式
Permuted block randomization, fixed
盲法
Participant Blinded

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • study will be conducted on a) 60 adult patients of 18-60 years of age , b) either sex and c) American society of Anaesthesiologists (ASA) physical status I , II and III d)scheduled to undergo elective cervical spine surgery requiring tracheal intubation with manual in line stabilization of neck under general anaesthesia.

排除标准

  • a) Patients with following predictors of difficult airway : 1)Modified Mallampati class IV, 2)Interincisor distance < 4.0 cm, 3)Upper lip bite test class >1, 4)Buck teeth and poor dentition with high risk of damage, 5)Oropharyngeal pathology or facial abnormality, 6)BMI >30kg /metre
  • b) Haemodynamic or pulmonary compromise, high risk of pulmonary aspiration and cardiac disease and Hypertension.
  • c) Pregnancy.

结局指标

主要结局

To compare Intubation difficulty scale score with C-MAC D-blade videolaryngoscope and McCoy laryngoscope for tracheal intubation with manual in line stabilization of neck in the study population

时间窗: At the time of intubation

次要结局

  • Total time taken to secure the airway,(Number of intubation attempts ,)

研究者

发起方
Vardhman Mahavir Medical College and Safdarjung Hospital
申办方类型
Government medical college

研究点 (1)

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