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临床试验/CTRI/2025/01/079214
CTRI/2025/01/079214招募中不适用

Comparison of endotracheal intubation through BlockBuster® versus Fastrach® LMA (Laryngeal Mask Airway) with fiberoptic guidance

BARC hospital1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2025年1月2日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
100
试验地点
1
主要终点
Time taken for intubation and ease of tracheal intubation

研究概览

简要总结

A prospective, randomized, comparative study to compare the ease of intubation through Blockbuster LMA versus Fastrach LMA with fiberoptic guidance in patients undergoing elective surgery under general anaesthesia.

The ease of intubation will be measured based on time taken to intubate and the number of attempts taken to intubate.

The grade of fiberoptic view of the glottis, presence of blood on the LMA and sore throat before discharge from recovery room will also be noted.

The time for insertion will be noted from picking of LMA till adequate ventilation is established with square wave capnogram.

Ease of insertion of the LMA will be graded as easy, difficult or failure. An easy insertion is defined as placement without resistance following a single attempt. More than one attempt will be considered a difficult insertion. A failed insertion will be defined as failure to insert the device after three attempts.

The score of the bronchoscopic view of the glottis will be noted

Brimacombe score:

  1. vocal cords not seen

  2. cords with anterior epiglottis seen

  3. cords plus posterior epiglottis seen

  4. only cords visible

The ease of ETT placement will be noted.

Time required for the ETT placement will be noted (the time interval between picking up the fiberscope loaded with ETT till square wave capnogram is seen).

Time required to remove LMA will be noted. After LMA removal, the tube cuff will be reinflated and connected to the ventilator circuit and anaesthesia will be continued by balanced general anaesthesia.

Damage or blood on cuff of LMA will be noted.

After the surgery is completed, presence of sore throat will be recorded.

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

  • Adult patients (age: 18-60yrs).
  • Patients with ASA physical status I to III.
  • Patients with adequate mouth opening of at least 3cms.

排除标准

  • Oropharyngeal pathology Morbid obesity Pregnancy Patients with gastroesophageal reflux.

结局指标

主要结局

Time taken for intubation and ease of tracheal intubation

时间窗: minutes, seconds

次要结局

  • 1. Time taken for LMA placement.(2. Ease of insertion of LMA.)

研究者

发起方
BARC hospital
申办方类型
Other [DNB teaching institute]

研究点 (1)

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