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临床试验/CTRI/2024/05/067364
CTRI/2024/05/067364尚未招募2/3 期

A Comparative Study Between LMA Blockbuster and LMA Protector as conduit for Blind Tracheal Intubation in patients undergoing General Anaesthesia -A Prospective Randomised Controlled Study

Department of Anaesthesiology and Critical Care JNMCHAMU ALIGARH1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年6月1日最近更新:

试验速览

阶段
2/3 期
状态
尚未招募
发起方
入组人数
60
试验地点
1
主要终点
Evaluation of first attempt success rate of blind intubation through LMA Blockbuster and LMA Protector

研究概览

简要总结

A randomised controlled study to compare the success rate of  LMA Blockbuster and LMA Protector as conduit for blind  tracheal intubation in patients undergoing operative procedures in general  anaesthesia

The first attempt success rate is very high with majority of supraglottic devices

This makes supraglottic airway devices an indispensible gadget in difficult airway management armamenterium

However 2nd generation supraglottic devices are being extensively used in elective anaesthetic cases

The recently introduced supraglottic devices are LMA Protector and LMA Blockbuster

there are studies on blind intubation via LMA  Blockbuster . However , there is no controlled study on LMA Protector as conduit for intubation

So We are comparing  the first attempt success rate of blind intubation through LMA Protector and LMA blockbuster- this is our primary aim of study

研究设计

研究类型
Interventional
分配方式
Randomized

入排标准

年龄范围
20.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • ASA Grade I & II patients Age between 20-70 years Weight between 40-70 kg Patients of both sexes All classes of MP Grades.

排除标准

  • Any pathology of the oral cavity that may obstruct the insertion of device Mouth opening less than 2.5cm Potentially full stomach patients (trauma morbid obesity history of gastric regurgitation and heart burn full term pregnancy) •risk of oesophageal reflux (hiatus hernia).
  • •Bleeding disorder.
  • •Patients having Cardiorespiratory problems.
  • •Unable to provide informed consent.

结局指标

主要结局

Evaluation of first attempt success rate of blind intubation through LMA Blockbuster and LMA Protector

时间窗: It will be considered only when the endotracheal tube will be inserted into green channel of LMA until the confirmation through capnographic waveform in first attempt

次要结局

  • Comparison of time for successful tracheal intubation(The time for successful tracheal intubation will be started when the endotracheal tube will be inserted into the green channel of LMA until the confirmation through capnographic waveform.Time for first intubation attempt will be measured only)
  • Number of attempts taken for intubation(More than 2 attempts will be considered as failure of blind intubation and ventilation was continued through LMA.)
  • Number of Manouvers required to intubate through Supraglottic device
  • Hemodynamic changes(pulse rate, SBP, DBP, MAP, SpO2 will be noted before and after (immediately, 1min & 5min) device insertion)
  • Complications(Number of patients complaining of immediate sore throat.)

研究者

发起方
Department of Anaesthesiology and Critical Care JNMCHAMU ALIGARH
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

DEEKSHA SINGH

Jawahar Lal Nehru Medical College and Hospital, Aligarh Muslim University, Aligarh

研究点 (1)

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