A Randomized Controlled Trial Comparing Full Glottis View vs. Partial Glottis View During Intubation Using CMAC D-Blade Video Laryngoscope in Simulated Cervical Injury Patient
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 104
- 试验地点
- 1
- 主要终点
- Intubation time
研究概览
简要总结
Direct laryngoscope requires proper alignment of the oro-pharyngeal-laryngeal axis to provide an optimal glottic view for intubation. However, in cervical spine patients, this alignment is not possible thus resulting in an increased risk of fail intubations.
D-blade comes with an elliptically tapered blade shape rising at the distal end to provide better glottic visualization in comparison with direct laryngoscopes. Hence, CMAC D-blade is preferred in simulated cervical spine injury where intubator needs to maintain a neutral neck position. However, intubation time may be significantly longer due to difficulty in negotiating the endotracheal tube pass vocal cord and impingement of endotracheal tube to the anterior wall of trachea.
There is a study published Glidescope which is also a hyperangulated videolaryngoscope suggested that obtaining a partial glottic view of larynx may facilitate a faster and easier tracheal intubation when compare to a full glottis view. The aim of this study is to clinically evaluate the time of tracheal intubation in relation to the full glottic view vs. partial glottic view which is deliberately obtained when using CMAC D-blade video laryngoscopy in simulated cervical spine injury.
详细描述
Direct laryngoscope requires proper alignment of the oro-pharyngeal-laryngeal axis to provide the best laryngeal view for intubation. In cervical spine patients, this alignment is not possible resulting in an increased risk of failed intubations. Difficult intubation and failed tracheal intubation are among the major causes of morbidity and mortality associated with anesthesia.
In recent years, video laryngoscope has played an increasingly important role in the management of patients with unanticipated difficult or failed endotracheal intubation. When compared with a direct laryngoscope, the video laryngoscope achieved a better view of the glottis and a high rate of successful intubation.
On comparing the C-MAC with the conventional Macintosh blade, a conventional C-MAC Macintosh blade 3 and D-blade have a blade angulation of 18° and 40° in the D-blade respectively. In addition, with D-blade is an elliptically tapered blade-shaped rising to distal.
This highly angulated C-MAC D blade provides a better glottic visualization in comparison to the direct laryngoscopes and in simulated cervical spine injury. This resulted in successful intubation in routine induction of anesthesia and rescue intubation in patients with difficult airway with C-MAC D Blade. But in terms of intubation time, study has shown a significantly shorter time with C-MAC D Blade compared with other indirect laryngoscopes. This may be due to a common problem seen in indirect video laryngoscopy whereby a good glottic view does not always allow advancing the tube into the trachea.
A study has been conducted on Glidescope which is also a hyperangulated blade suggested that obtaining a partial glottic view of larynx may facilitate a faster and easier tracheal intubation when compare to a full glottis view. Randomised controlled trial also showed that GlideScope and C-MAC D blade video laryngoscope using manual inline axial stabilization (MIAS) for tracheal intubation in patients with cervical spine injury/pathology were equally efficacious.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All patients with American Society of Anaesthesiologist (ASA) physical status I-III
- •Age (≥21-75 years old)
- •General anaesthesia requiring tracheal intubation
- •Provide written consent to participate in the study
排除标准
- •Pregnancy
- •Body mass index (BMI) ≥ 35
- •Condition requires rapid sequence induction
- •Need for fibreoptic intubation
- •Need for nasal intubation
- •Documented difficult airway during previous surgery
- •Recent (3 months) active ischemic heart disease
- •Recent (3 months) cerebrovascular disease
- •Acute exacerbation of respiratory disease (eg. Uncontrolled asthma, Chronic Obstructive Pulmonary Disease)
研究组 & 干预措施
Full glottic view on CMAC- D blade
Deliberately obtaining a full glottis view is defined as negotiation and advancement of CMAC D blade tip positioned at the vallecula. Occasionally, external laryngeal pressure may be needed to assist in obtaining a full glottic view. The full glottic view is defined as a percentage of glottic opening (POGO) approximate 100%.
干预措施: CMAC D-blade videolaryngoscope with full or partial glottic view (Device)
Partial glottic view on CMAC- D blade
The partial glottis view is defined as a percentage of glottic opening <50%. This is achieved by deliberately position the CMAC D-blade tip proximally away from the vallecular.
干预措施: CMAC D-blade videolaryngoscope with full or partial glottic view (Device)
结局指标
主要结局
Intubation time
时间窗: during the intervention
This is the time taken from CMAC laryngoscope blade passes patient's lip until the recording of first end tidal CO2 (EtCO2); assessed up to 120 seconds.
First attempt successful intubation attempt
时间窗: during the intervention
First intubation attempt success rate between two groups; assessed up to maximum 2 attempts
次要结局
- Hemodynamic changes(immediately after the intervention)
- Airway trauma(immediately after the surgery)
- Time to obtain glottic view(during the intervention)
研究者
Dr. Cheong Chao Chia
Doctor/ Clinical Anaesthesiologist/ Clinical Lecturer
University of Malaya