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临床试验/CTRI/2025/08/092331
CTRI/2025/08/092331尚未招募不适用

Evaluation of i-gel plus as a conduit for fiberoptic intubation in adults : An observational study

Maulana Azad Medical College and associated Lok Nayak Hospital1 个研究点 分布在 1 个国家目标入组 35 人开始时间: 2025年8月18日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
35
试验地点
1
主要终点
Time required for fibreoptic intubation (FOI) using i-gel plus (in minutes)

研究概览

简要总结

We are evaluating device i-gel plus as a conduit for fibreoptic intubation in adults in patients undergoing general anaesthesia in Lok Nayak hospital, Delhi after meeting inclusion criteria. A total of 35 patients will be enrolled for the study. Patients will be explained about the study and written informed consent will be taken. Size of  i-gel plus will be selected according to weight of patient and fibreoptic bronchoscope will be inserted. ETT will be railed over fibrescope using i-gel plus as a conduit. After confirmation of proper ventilation i-gel plus will be removed keeping ETTin place. We will be using standard general anaesthesia for induction of patients and time taken for fibreoptic intubation will be noted. Along with it Brimacombe score for glottic view, ease of insertion of i-gel plus, number of attempts required for successful intubation, complications will also be noted.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Age group 18-60 years of either gender.
  • American Society of Anaesthesiologists Grade I and II patients.
  • 3.Patients assessed to have El-Ganzouri score(EL.GA)smaller than 4.

排除标准

  • 1.Surgical procedure involving oral cavity or prone position 2.Pregnant women 3.Risk of aspiration pneumonitis with history of gastro-oesophageal reflux 4.Obesity (BMI greater than or equal to 30) 5.Any Airway pathology.

结局指标

主要结局

Time required for fibreoptic intubation (FOI) using i-gel plus (in minutes)

时间窗: baseline at time of intubation

次要结局

  • Upward flexion angle of fibrescope tip to achieve grade 4 of Brimacombe score for i-gel plus using protractor (in degrees)
  • Time taken for i-gel plus insertion (in minutes/seconds)
  • Number of attempts required for successful intubation using i-gel plus
  • Grade of ease of insertion of i-gel plus
  • Brimacombe score for fibreoptic view of glottis
  • Time taken for i-gel plus removal with ETT in place(in minutes/seconds)(after intubation)
  • Assess complications after removal of i-gel plus and ETT

研究者

发起方
Maulana Azad Medical College and associated Lok Nayak Hospital
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Divyashri Chaukhe

Maulana Azad Medical College and associated Lok Nayak Hospital

研究点 (1)

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