跳至主要内容
临床试验/CTRI/2024/03/063885
CTRI/2024/03/063885尚未招募Unknown

To evaluate the ease of endotracheal intubation using preloaded bougie vs standard bougie vs stylet guided technique in difficult airway patients undergoing elective surgeries. A randomised three arm clinical trial.

Aarupadai veedu medical college and hospital.1 个研究点 分布在 1 个国家目标入组 195 人开始时间: 2024年3月22日最近更新:

试验速览

阶段
Unknown
状态
尚未招募
发起方
入组人数
195
试验地点
1
主要终点
The primary objective of the study is to compare the time taken for intubation with endotracheal tube in difficult airway patients undergoing elective surgery under general anaesthesia.

研究概览

简要总结

Successful intubation in the first attempt has been associated with lower incidence of complications. As the number of attempts and the time to intubate increase, injury to airway and risk of desaturation may increase which is potentially life threatening. Various adjuncts and techniques have been devised to facilitate ease of insertion of endotracheal tube during such situations. Tracheal tube introducer, also known as bougie, has been used extensively in difficult airway scenarios to ensure first pass success. Another technique is the use of stylet along with endotracheal tube for intubation. However, it has been noted from previous studies that the usage of bougie leads to less airway trauma as less force needs to be applied during airway manipulation. Preloaded bougie is a modification of the standard technique by which the time taken to introduce endotracheal tube can be minimised. Up to now, only stylet and standard bougie techniques were routinely being used for difficult airway intubation. In this study, we will be using preloaded bougie technique for ease of endotracheal intubation compared with standard bougie and stylet guided techniques in difficult airway.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Participant Blinded

入排标准

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

入选标准

  • •ASA I and ASA II
  • •MPG 3 and 4
  • •AGE: 18-60 years
  • •Male and female.

排除标准

  • •Patients unwilling to enroll for study
  • •Change in the technique of intubation
  • •Patients with preoperative sore throat and upper and lower respiratory tract infection
  • •Patients with oropharyngeal pathology.

结局指标

主要结局

The primary objective of the study is to compare the time taken for intubation with endotracheal tube in difficult airway patients undergoing elective surgery under general anaesthesia.

时间窗: 2 minutes

次要结局

  • Manipulations required to aid intubation.(3 minutes)
  • Number of attempts to intubation(2 minutes)
  • To assess incidence of post operative airway related complications like sore throat(24 hours)
  • To assess complications like desaturation, oesophageal intubation and airway trauma during intubation.(5 minutes)

研究者

发起方
Aarupadai veedu medical college and hospital.
申办方类型
Private medical college

研究点 (1)

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