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临床试验/CTRI/2020/09/028011
CTRI/2020/09/028011尚未招募不适用

Comparison of C-MAC video-laryngoscope with D-Blade, C-MAC video-laryngoscope with standard blade, and Macintosh Laryngoscopes for intubation with cervical spine immobilization: a randomized study

AIIMS New Delhi1 个研究点 分布在 1 个国家目标入组 123 人开始时间: 2020年1月10日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
123
试验地点
1
主要终点
Cormack Lehane (CL) grade of laryngoscopic view

研究概览

简要总结

Title: Comparison of C-MAC video-laryngoscope with D-Blade, C-MAC video-laryngoscope with standard blade, and Macintosh Laryngoscopes for intubation with cervical spine immobilization: a randomized study.

Macintosh laryngoscope is the most commonly used device for intubation in anesthesia practice. Difficult intubation still a major cause of morbidity and mortality associated with anaesthesia. Recently, viedeolaryngoscopes are becoming very popular for difficult intubation management because it increases glottic view and the success of intubation. There are many studies which show C-MAC viedeolaryngoscopes improves laryngeal view compared to direct laryngoscopy. Manual in-line stabilization (MILS) is used during procedures like airway management in patients with C-spine injury to minimize cervical movement. But MILS make the intubation difficult by decreasing the view of laryngoscopy.        A new C-MAC D-Blade is introduced which can be used as an alternative in difficult airway situations. The advantage of the C-MAC video-laryngoscope with a D-Blade in presence of cervical spine immobilization is not known. The purpose of this randomized controlled study is to com­pare the C-MAC video-laryngoscope with D-Blade, C-MAC video-laryngoscope with a standard blade, and Macintosh Laryngoscopes for intubation for endotracheal intubation under general anaesthesia with manual in-line stabilization (MILS).

The primary objective is to compare the Cormack Lehane (CL) grade of laryngoscopic view between C-MAC video-laryngoscope with D-Blade, C-MAC video-laryngoscope with standard blade, and Macintosh Laryngoscopes in patients undergoing general anesthesia (GA) using MILS. Following approval of Institute Ethics Committee, 123 patients in between the age group of 18-60 years, will be enrolled in a prospective, randomized, parallel group, multiple arm trial study. Patients aged between 18 and 60 years of either gender belonging to ASA physical status I–II undergoing elective cervical spine surgery requiring GA will be included.

The patients will be randomized to one of the following three groups (41 each) on the basis of a computer-generated randomization chart: Group I: Macintosh laryngoscope (Group M), Group II: C-MAC videolaryngoscope (Group C), Group III: C-MAC D video laryngoscope (Group D).

All patients enrolled for the study will receive general anesthesia with tracheal intubation. The neck will be immobilized using MILS by holding the sides of the neck and the mastoid processes, thus preventing flexion/extension or rotational movements of head and neck. Cormack Lehane (CL) grade will be assessed after the first attempt of laryngoscopy. Primary outcome measure will be Cormack Lehane (CL) grade of laryngoscopic view. The secondary outcome will be time taken for successful intubation, success rate of first attempt intubation, number of attempts of intubation, number of optimization maneuvers required to aid tracheal intubation, complication,  difficulty score and Hemodynamic changes during the intubation process.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Participant and Outcome Assessor 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

  • Patients aged between 18 and 60 years of either gender belonging to ASA physical status I–II undergoing elective cervical spine surgery requiring GA.

排除标准

  • Patients with risk factors for difficult mask ventilation Patients with risk factors for gastric aspiration (obesity) Patients with difficult airway such as previous neck surgery and mouth opening less than 3 cm will be excluded from the study.
  • Anticipated difficult airway including Mallampati grade 3 and 4 airway.

结局指标

主要结局

Cormack Lehane (CL) grade of laryngoscopic view

时间窗: at the point when blade of the laryngoscope is placed inside the mouth

次要结局

  • Time taken for successful intubation(Success rate of first attempt intubation)

研究者

发起方
AIIMS New Delhi
申办方类型
Research institution

研究点 (1)

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