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临床试验/CTRI/2025/09/094920
CTRI/2025/09/094920招募中4 期

Optimizing Tracheal Intubation in Obese Patients: A Randomized Trial of Standard Vs. Flexible Tip Bougies with Hyperangulated Videolaryngoscope

All India Institute of Medical Sciences New Delhi1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2025年9月29日最近更新:

试验速览

阶段
4 期
状态
招募中
发起方
入组人数
80
试验地点
1
主要终点
Modified intubation difficulty scale score

研究概览

简要总结

Obese patients present unique airway management challenges due to altered anatomy, leading to increased risk of difficult intubation and peri-intubation complications. Hyperangulated videolaryngoscopes (VLs) like the C-MAC D-Blade enhance glottic visualization but make tube insertion more challenging. This prospective randomized trial aims to compare the effectiveness of standard bougie versus flexible-tip bougie for tracheal intubation using a C-MAC D-Blade in obese adults. After preoperative evaluation and informed consent, eligible patients will be randomised into two groups: Standard Bougie group and Flexible-Tip Bougie group. Following standard general anesthesia induction and neuromuscular blockade, intubation will be performed in the ramped position using the assigned bougie technique. An experienced anesthesiologist will conduct all intubations. The primary outcome is the modified Intubation Difficulty Scale (mIDS) score. Secondary outcomes include intubation time, number of attempts, first attempt success rate, optimization maneuvers, and complications such as desaturation or dental trauma. This trial seeks to identify which bougie provides greater ease and success during tracheal intubation in obese surgical patients, thereby contributing to evidence-based airway management strategies.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant Blinded

入排标准

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

入选标准

  • BMI more than 30 and ASA 1-3.

排除标准

  • 1.Mouth opening less than 2 fingers
  • Emergency surgery 3.Nasal intubation & Awake tracheal intubation 4.Patient requiring rapid sequence intubation 5.Patient having intraoral tumors 6.Patient undergoing elective oral surgery such as micro laryngeal surgery, tonsillectomy.

结局指标

主要结局

Modified intubation difficulty scale score

时间窗: From anaesthesia induction to endotracheal intubation at 0 minutes, 5 minutes, 10 minutes, 15 minutes after intubation.

次要结局

  • Laryngoscopy time, First attempt intubation success rate, Number of intubations, Intubation difficulty scores, Incidence of failed intubation, Use of optimization manoeuvres, Heart rate (HR) & oxygen saturation trends during intubation, Complication-desaturation, dental trauma, oesophageal intubation

研究者

发起方
All India Institute of Medical Sciences New Delhi
申办方类型
Research institution
责任方
Principal Investigator
主要研究者

Dr Nishant Patel

All India Institute of Medical Sciences, New Delhi

研究点 (1)

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