: Comparison of tracheal intubation using King Vision and C-MAC videolaryngoscopes in patients with cervical spine immobilization
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- First attempt intubation success, Intubation Difficulty Score and POGO score
研究概览
简要总结
A. **Study procedure:**After approval of JIPMER scientific advisory committee, Institute Ethicscommittee, registration from CTRI. Informed written consent from patient orrelatives will be taken. A total of 180 patients meeting inclusion criteriawill be enrolled in the study and randomized into one of the 3 groups K, C, D. RegularPre-medications will be given with tablet famotidine 20 mg, diazepam 5mg in thenight the day before surgery and tablet famotidine 20mg, Perinorm 10mg,diazepam 5mg in the morning of the day of surgery. After securing IV line, connectingstandard monitors, pre-oxygenation will be done. Standard intubation protocolwill be followed by using fentanyl 2 ug/kg, propofol 2mg/kg, vecuronium0.1mg/kg. Cervical spine immobilization will be maintained by using a rigidcervical collar or manual in line stabilization and tracheal intubation will beperformed by one of these 3 video laryngoscopes following manufacturers’recommendations. Standard endotracheal tube of size 8 for the male and size 7for the female will be used for all the patients in the study.
B. Data collection methods includingsettings and periodicity:
a) First attempt success rate
b) More than 2 attempts – failure ofthe intubation
c) Time for intubation – from scopepassing teeth to tube seen passing vocal cords Grading of intubation difficulty – modified IDS score8,9
d) Percentage of glottic opening (POGO)score10
e) Cormack - Lehane grading of glotticview
f) Alternative techniques used likeBougie, External laryngeal manipulation, or Specialist needed.
g) Ease of insertion
h) Complications – airway trauma, esophagealintubation
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Inclusion criteria includes adults posted for elective surgeries requiring general anesthesia with intubation, with proven/suspected cervical spinal cord injury on cervical immobilization with rigid collar.
排除标准
- •Exclusion criteria includes anticipated difficult airways with any other disorders and aspiration risk, other than cervical spine injury.
结局指标
主要结局
First attempt intubation success, Intubation Difficulty Score and POGO score
时间窗: First attempt intubation success in percentage, Intubation Difficulty Score based on 10 point score and POGO score based on percentage of glottic opening will be recorded during endotracheal intubation
次要结局
- Time for intubation,any maneuvers required(Time in seconds that is time from insertion of Videolaryngoscope to the visualization of passing of the endotracheal tube through the glottis opening)