Comparison of intubation by anaesthesia residents using C-MAC C-blade video laryngoscope- with and without bougie: A randomized clinical trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- To compare the time taken for intubation by anaesthesia residents using C-MAC C-blade video laryngoscope-with bougie and without bougie guided endotracheal tube.
研究概览
简要总结
C-MAC video laryngoscope is trending as the routine standard of care in western countries. It is also expected to become so in all other places in future. The view obtained on a video laryngoscope screen may not always correspond to ease of intubation as it is an indirect view and does not correspond to the line of sight. Thus various aids like stylets, bougie or forceps might be used while intubation. As C-MAC laryngoscope is similar to a Macintosh laryngoscope without an acute angle the manufacturer does not recommend use of a stylet but people have been using it with or without stylet depending on their preferences. A stylet due to its stiff nature when used with video laryngoscopes has been found to cause pharyngeal wall injuries. Compared to the rigid stylet, bougie is stiff yet a flexible device with little incidence of injury to soft tissue. A bougie due to its smaller diameter and bent tip can be easily negotiated into the larynx. It has been shown that bougie improves the success rates of intubation with direct laryngoscopy especially in novice learners even with less instruction and practice. Therefore, this study aims to compare intubation using C-MAC laryngoscope by anaesthesia residents with and without bougie guided endotracheal tube.
Some studies have compared angulated C-MAC D-blade laryngoscope using bougie and stylet guided endotracheal tube and others have compared C-MAC C-blade with direct laryngoscopy. But no studies are available so far combining the use of C-MAC C-blade with bougie or without bougie guided endotracheal tube under routine conditions. In this study we compare two techniques for endotracheal intubation by anaesthesia residents using C-MAC C-blade video laryngoscope- with bougie and without bougie in patients planned for routine endotracheal intubation during general anaesthesia.
The study hypothesis is that endotracheal intubation by anaesthesia residents using C-MAC laryngoscope with bougie guided endotracheal tube will take less time when compared to using C-MAC without bougie guided endotracheal tube.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 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
- •All patients with age 18-60 years undergoing elective surgery in JIPMER, belonging to ASA class 1-2 planned for general anaesthesia with orotracheal intubation will be included in the study.
排除标准
- •Pregnant women
- •Patients with aspiration risk and those requiring rapid sequence induction
- •Patients planned for awake fiber-optic or nasal intubation
- •Patients with difficult airway which includes mouth opening less than 3 centimetres, Mallampatti class 3 or more, thyromental distance less than 6 centimetres, restricted neck extension.
- •Patients not willing for the study.
结局指标
主要结局
To compare the time taken for intubation by anaesthesia residents using C-MAC C-blade video laryngoscope-with bougie and without bougie guided endotracheal tube.
时间窗: Duration in seconds. The time for intubation will be recorded as the interval between the introduction of C-MAC C-blade into the patients mouth to the appearance of End tidal carbon dioxide trace in the monitor. It is done during intubation under general anaesthesia.
次要结局
- To compare the laryngoscopy time in each technique.
- To compare the number of attempts at redirection of the tube and the number of failed intubations in each technique.(The number of failed intubation and the number of times of tube redirection is noted during intubation.)
- To compare the user review regarding the ease of intubation in each technique.(The intubators opinion regarding the ease of intubation is assessed using an ordinal scale. 1- very easy, 2- easy, 3- moderately difficult, 4- very difficult. It is done after intubation.)
- To assess and compare the hemodynamic responses associated with each technique. {Heart rate(HR), Blood pressure(BP)}(Baseline heart rate and blood pressure in beats per minute and millimetres of mercury respectively is noted before induction, then every one minute from the time of intubation for 5 minutes.)
- To compare the need for external laryngeal maneuvers and the number of times of repositioning of C-MAC C-blade needed for each technique.(It is done during intubation of trachea.)
- To assess and compare postoperative pharyngolaryngeal complaints of the patients.( sore throat, throat pain, dysphonia, dysphagia) and To record any episodes of desaturation.(Patient will be reviewed 24 hours after the surgery to assess for presence of sore throat, throat pain, dysphonia or dysphagia.)