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临床试验/NCT02566135
NCT02566135已完成不适用

I-gel Versus C-LMA as a Conduit for Tracheal Intubation Using Ventilating Bougie

Medical College Baroda0 个研究点目标入组 58 人开始时间: 2014年3月1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
发起方
入组人数
58
主要终点
Total Intubation Time

研究概览

简要总结

Supraglottic Airway devices(SGAs) like I-Gel and C-LMA ( classic laryngeal mask airway ) have been used as a conduit for tracheal intubation using ventilating bougie. General Anaesthesia with tracheal intubation is one of the technique for giving anaesthesia. Tracheal intubation may become difficult sometimes and endangers patients life. Using SGAs as a conduit for tracheal intubation helps in securing airway. This will be further facilitated by using ventilating bougie, as it maintains oxygenation.

详细描述

SGAs have been used as a conduit for tracheal intubation using ventilating bougie. Patients were anaesthetised with intravenous induction agent, non-depolarising muscle relaxant and then SGAs were inserted. Two groups were compared. In group I : I-gel was inserted, its position was confirmed and then ventilating bougie was inserted through it. It's position was confirmed, then I-gel was removed , Endotracheal tube was railroaded over ventilating bougie and it's position was confirmed. In group C : C-LMA was inserted, its position was confirmed and then ventilating bougie was inserted through it. It's position was confirmed, then C-LMA was removed , Endotracheal tube was railroaded over ventilating bougie and it's position was confirmed.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • age 18 to 60 years
  • Gender : either sex
  • American society of Anaesthesiologist's Physical Status (ASAPS) I and II
  • Patients posted for surgery requiring general anaesthesia and endotracheal intubation.

排除标准

  • age <18 years and > 60 years
  • ASAPS III or IV
  • Obesity body mass index >25
  • Patients with mouth opening <2cms
  • Patients with Malampatti grade III and IV
  • Patients having history of gastro-esophageal reflux disease
  • Patients with history of inadequate fasting
  • Patients with known or anticipated difficult tracheal intubation or face-mask ventilation.

研究组 & 干预措施

Group-I

Active Comparator

Tracheal intubation using I-gel and ventilating bougie insertion. In Group-I, following general anaesthesia I-gel is to be inserted, through it ventilating bougie is to be inserted then I-gel is to be removed and endotracheal tube is to be railroaded over ventilating bougie. Then ventilating bougie is to be removed.

干预措施: Tracheal Intubation using I-gel and ventilating bougie (Device)

Group-C

Active Comparator

Tracheal intubation using C-LMA and ventilating bougie insertion. In Group-C, following general anaesthesia C-LMA is to be inserted, through it ventilating bougie is to be inserted then C-LMA is to be removed and endotracheal tube is to be railroaded over ventilating bougie. Then ventilating bougie is to be removed.

干预措施: Tracheal Intubation using C-LMA and ventilating bougie (Device)

结局指标

主要结局

Total Intubation Time

时间窗: 5 minutes

Number of Attempts for I-gel or Classic-LMA Insertions

时间窗: 60 seconds

Number of Attempts for Ventilating Bougie Insertions Through I-gel or C-LMA

时间窗: 45 seconds

Number of Attempts for Railroading of Endotracheal Tube Over Ventilating Bougie

时间窗: 30 seconds

Time of Insertion

时间窗: 5 minutes

次要结局

  • Diastolic Blood Pressure(25 minutes)
  • Heart Rate(25 minutes)
  • Systolic Blood Pressure(25 minutes)

研究者

发起方
Medical College Baroda
申办方类型
Other
责任方
Principal Investigator
主要研究者

DR ADITI AMRUTLAL DHIMAR

DR ADITI AMRUTLAL DHIMAR

Medical College Baroda

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