跳至主要内容
临床试验/CTRI/2025/11/097135
CTRI/2025/11/097135尚未招募4 期

A Randomized comparative study between the modified tube first technique and conventional technique for awake nasal fiberoptic intubation in patients with anticipated difficult airways

Sawai Mansingh medical college and attached hospital Jaipur1 个研究点 分布在 1 个国家目标入组 94 人开始时间: 2025年11月24日最近更新:

试验速览

阶段
4 期
状态
尚未招募
发起方
入组人数
94
试验地点
1
主要终点
Mean time taken from the insertion of the fibre optic bronchoscope or endotracheal tube to the successful placement and inflation of the cuff in the trachea

研究概览

简要总结

This study is a prospective, randomised open label trail conducted on 94 patients with an anticipated difficult airway undergoing oromaxillofacial surgery. The patients were randomised into modified tube first MTF group (47)and conventional technique group(47). Times from insertion of the fibre optic scope into nares till vocal cord visualisation T1 and from T1 to complete intubation T2 were measured and compared.our study shows that MTF is better than conventional technique for awake nasotracheal intubation, requiring lesser time and attempts while maintaining airway patently

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 55.00 Year(s)(—)
性别
All

入选标准

  • 1.Patients undergoing oral maxillofacial surgery with anticipated difficult intubation.
  • Patients of either sex aged between 18 -55 years.
  • American Society of Anesthesiologists (ASA) physical status classes I and II.
  • Anticipated difficult airway, defined as Mallampati grade (MMG).
  • Scheduled for elective surgery.
  • Willing to provide written informed consen.

排除标准

  • 1.Refusal to provide written informed consent.
  • Patient’s Presence of nasal mass.
  • Bleeding disorders.
  • Base of skull fracture.
  • History of nasopharyngeal surgery.

结局指标

主要结局

Mean time taken from the insertion of the fibre optic bronchoscope or endotracheal tube to the successful placement and inflation of the cuff in the trachea

时间窗: Mean time taken from the insertion of the fibre optic bronchoscope or endotracheal tube to the successful placement and inflation of the cuff in the trachea

次要结局

  • Mean number of attempts(Ease of device placement)

研究者

发起方
Sawai Mansingh medical college and attached hospital Jaipur
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Rajni Mathur

Department of anaesthesia, SMS medical college and attached hospital Jaipur

研究点 (1)

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