跳至主要内容
临床试验/CTRI/2023/03/050833
CTRI/2023/03/050833已完成不适用

ENDOTRACHEAL INTUBATION BY INTUBATING LARYNGEAL MASK AIRWAY (FASTRACH™) -ALONE OR ASSISTED BY VIDEO ENDOSCOPE (FIVE™) – A RANDOMISED CONTROLLED TRIAL

Vijayanagar institute of medical sciences1 个研究点 分布在 1 个国家目标入组 104 人开始时间: 2023年3月24日最近更新:

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
First attempt intubation success rate with the two techniques

研究概览

简要总结

The prime responsibility and aim of any anesthesiologist is the maintenance of airway. From the

time endotracheal intubation was introduced, undue problems have occurred due to failed

ventilation and tracheal intubation. Many studies have proved that airway mismanagement

occurs in most cases due to lack of proper expertise and equipments.

The ILMA was considered as the “gold standard†among the

supraglottic airway devices when it was initially released for use. It has showed a high success

rate for blind or fibreoptic-guided tracheal intubation in patients with both expected and

unexpected difficult airways. Another objective of use of ILMA was to eliminate the need to

distort the anterior pharyngeal anatomy in order to visualize the laryngeal inlet, making the device

applicable to patients with a history of difficult intubation and a high or anterior larynx.

There are number of studies comparing ILMA with other supraglottic airway devices with respect

to obtundation of pressor response, ease of intubation and time taken for intubation. But there is

paucity of studies comparing blind intubation with ILMA and intubation with further aided by

use of video endoscopes. Hence present study is planned to compare the ease of intubation

between intubating laryngeal mask airway (ILMA) alone and that with flexible intubating video

endoscope (FIVE).

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Investigator Blinded

入排标准

年龄范围
18.00 Month(s) 至 55.00 Year(s)(—)
性别
All

入选标准

  • 1.Patients of 18-55 years of age, of either sex, posted for elective surgeries under general anaesthesia .
  • 2.ASA physical status 1&2 3.Modified Mallampatti (Samsoon and Young)class I or II 4.BMI <30 5.Mouth opening ≥ 2 fingers.

排除标准

  • 1.Refusal by patients for the procedure.
  • 2.Anticipated difficult airway.
  • 3.Patients with increased risk of aspiration or having a history of symptomatic GERD.
  • 4.Symptoms related to laryngeal pharyngeal anomaly.

结局指标

主要结局

First attempt intubation success rate with the two techniques

时间窗: Comparing time taken for intubation with the 2 techniques

次要结局

  • 1.Duration of intubation,(2.Number of Attempts required for successful)

研究者

申办方类型
Government medical college

研究点 (1)

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