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临床试验/CTRI/2024/05/068190
CTRI/2024/05/068190尚未招募4 期

Comparison of Fiberoptic intubation with video assisted fiberoptic intubation in predicted difficult airway: A randomised controlled trial

Postgraduate Institute of Medical Education and research1 个研究点 分布在 1 个国家目标入组 84 人开始时间: 2024年6月10日最近更新:

试验速览

阶段
4 期
状态
尚未招募
入组人数
84
试验地点
1
主要终点
Time to intubation

研究概览

简要总结

84 adult patients of ASA status I and II in the age range of 18-65 years patients of either gender undergoing elective surgery requiring endotracheal intubation having at least 1 predictor of difficult intubation will be enrolled.Time taken to perform tracheal intubation will be recorded as primary objective.

First pass success rate, overall success rate, glottic visualization , intubation difficulty score, additional external maneuvers, hypoxemia defined as oxygen saturation less than 90%, hemodynamic changes and incidence of complications would be recorded as secondary objectives.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
Female

入选标准

  • ASA status I and II in the age range of 18-65 years patients of either gender undergoing elective surgery requiring endotracheal intubation having at least 1 predictor of difficult intubation.

排除标准

  • Patient’s Refusal mouth opening ( less than 22mm) Bleeding Disorders ASA Physical status 4 or higher Patients planned for Awake FOB will be excluded.

结局指标

主要结局

Time to intubation

时间窗: immediately after intubation

次要结局

  • Glottic view(30 seconds after laryngoscopy)
  • Success rate(1 minute after intubation)
  • hypoxemia(1 minute after intubation)
  • Hemodynamic changes(o minute, 1 minute, 3 minute, 5 minute, 10 minute, 15 minute after intubation)

研究者

申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr Vishal Saxena

Postgraduate institute of medical education and research

研究点 (1)

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