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临床试验/NCT04109898
NCT04109898已完成不适用

Comparison of Ease of I-gel Insertion With Two Different Techniques in Adults

Aga Khan University1 个研究点 分布在 1 个国家目标入组 114 人开始时间: 2019年9月7日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
114
试验地点
1
主要终点
adverse airway events

研究概览

简要总结

Study will evaluate the I-gel airway device standard insertion technique versus interventional (modified jaw thurst) insertion technique in adult patients. The half of the patients will receive standard and other half will receive the modified jaw thrust insertion technique

详细描述

The I-gel is used to provide the oxygenation and ventilation in anaesthetised patients. The inventor suggested insertion technique is called standard technique.

Standard I-gel insertion technique: I-gel insertion will be performed by firmly grasping the lubricated I-gel along the integral bite block site. I-gel cuff outlet will face towards the patient's chin and before insertion chin will be gently pressed down. The I-gel soft tip will be introduced into patient's mouth in a direction towards the hard palate. Then I-gel will be slide downwards and backwards along the hard palate with a continuous but gentle push until a definitive resistance is felt.

Modified jaw thrust technique: I-gel insertion will be performed by firmly grasping the lubricated I-gel along the integral bite block. I-gel cuff outlet will face towards the patient's chin and before insertion chin will be gently pressed down. The I-gel soft tip will be introduced into patient's mouth in a direction towards the hard palate and it slides gently into the oropharynx. I-gel will be left in oral cavity and both hands will be used to thrust the jaw by lifting the angle of mandible with little fingers and other fingers to stabilize the jaw then both thumbs will used to apply the balance force towards the final I-gel placement position by looking at the integral bite block mark at incisor teeth level.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
16 Years 至 60 Years(Child, Adult)
性别
All
接受健康志愿者
是

入选标准

  • •ASA I and II patients.
  • •Age 16 years to 60 years.
  • •Patient scheduled for elective surgical procedure.

排除标准

  • •Gastroesophageal reflux disorders
  • •Obesity BMI more than
  • •Pregnancy
  • •Reactive airway disease/asthma
  • •Patients with mallampati score III & IV
  • •Anticipated difficult airway
  • •Emergent surgery.
  • •Known allergic to isoflurane and propofol.

研究组 & 干预措施

standard I-gel insertion technique

No Intervention

Investigator will apply the recommended (standard) I-gel insertion technique in patients

Modified I-gel insertion technique

Experimental

Investigator will apply the modified (interventional) I-gel insertion technique in patients

干预措施: Supraglottic airway device (I-gel) insertion (Device)

结局指标

主要结局

adverse airway events

时间窗: 5 minutes

All study patients will be monitored for I-gel insertion resistance, insertion time duration, insertion attempts.

次要结局

  • adverse airway events(60 minutes)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dileep Kumar

Assistant Professor

Aga Khan University

研究点 (1)

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