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临床试验/CTRI/2021/04/033144
CTRI/2021/04/033144尚未招募不适用

Effectiveness of McCoy laryngoscopy and C-MAC D video laryngoscopy bladein managing predicted difficult airway under EEG entropy based anesthesia – A single blindrandomized control study

Bangalore Baptist Hospital1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2021年1月5日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
100
试验地点
1
主要终点
Intubation Difficulty Scale Score

研究概览

简要总结

Endotracheal intubation is anintegral part of general anaesthesia for most of the patients undergoingsurgery. Difficulty in ventilation and failure to intubate are the principalcauses of hypoxemia, aspiration, ischemic brain injury, cardiovascularcomplications and possibly leading to death. Airway accessories have beendeveloped over theyears likedifferent types ofblades, airways, bougies, supraglottic devices, fibreopticlaryngoscopeand C-MAC video laryngoscope for better vision and securing the airway.

C-MAC(Concurrent MediaAccess Control) video laryngoscope (Karl Storz, Germany) is one of suchindirect laryngoscope meant for videoscope guided intubation. It is introducedin the oral cavity and the operator views the larynx on the video screen whichguides the intubation.

McCoy laryngoscopy is atraditional method in use .It has a hinged tip that aids in improving theCormack and Lehane laryngoscopic view by 1 grade by lifting up the epiglottis. C-MACis not available still in many centres in India.

There are limitedliteratures comparing the C-MAC and McCoy laryngoscope in predicted difficultairway, so we designed a randomised control study to compare the effectivenessof  McCoy and CMAC laryngoscopy   inpredicted difficult airway in elective surgeries under EEG entropy-basedanaesthesia. This entropy based anaesthesia will ensure uniform and adequatedepth of anaesthesia during and after intubation when we compare both methods.

In this study, we intend tocompare both techniques for difficult intubation, in terms of success rates.

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 70.00 Year(s)(—)
性别
All

入选标准

  • ASA physical status grade 1, 2, 3 patients • Age 18-70 years of either sex • Predicted difficult airway with one of the following o Mallampati classification 3 and 4 o Mouth opening at least or more than 2cm o Restricted neck movements o TMD <6 cm o Short neck/double chin/increased neck circumference/Micro/retrognathia.

排除标准

  • o Patient refusal o Uncontrolled hypertension.
  • (>140/90 on regular antihypertensive treatment on o the day of surgery in preoperative area) o Coronary Artery disease o Pregnancy.

结局指标

主要结局

Intubation Difficulty Scale Score

时间窗: At 0,1,3,5 and 10 minutes after intubation

次要结局

  • To identify complications associated with both the laryngoscopes, like,injury to lips,gum,oral,dental trauma,and bronchospasm,stridor,laryngospasm,sore throat(after the surgery in post operative period.)

研究者

申办方类型
Private hospital/clinic

研究点 (1)

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