跳至主要内容
临床试验/CTRI/2025/11/097998
CTRI/2025/11/097998尚未招募不适用

Comparison of Efficacy of Videolaryngoscope (BPL) versus The Anaesthetist Society Scope (TAScope) for Endotracheal Intubation in Adult Patients with Cervical Spine Immobilization: A Randomized Clinical Trial

Regional Institute of Medical Sciences1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2025年12月20日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
70
试验地点
1

研究概览

简要总结

This study will be a single-blinded randomized clinical trial to compare the efficacy of BPL videolaryngoscope versus The Anaesthetist Society Scope (TAScope) for endotracheal intubation in adult patients with cervical spine immobilization with Philadelphia collar. After approval from the Research Ethics Board of RIMS, Imphal, a total number of 70 consenting patients (18 to 60 years, ASA I and II, Mallampati class I and II) will be randomized into one of the two groups of 35 each. In group A patients, the BPL videolaryngoscope will be used for endotracheal intubation. In group B patients, the TAScope will be used for endotracheal intubation. Data related to the procedure will be noted by an independent observer. Time to laryngoscopy, time to intubate, time for successful intubation and grade of the laryngoscopic view will be observed as primary outcomes. As secondary outcomes, the number of attempts at laryngoscopy, manoeuvres employed to facilitate intubation and complications during and immediately after intubation with the BPL videolaryngoscope and the TAScope will be noted. Data will be analyzed using the intention-to-treat (ITT) principle. Data will be recorded in a proforma, tabulated in the Microsoft Excel software and analyzed using IBM SPSS Version 26.0 software. A p value of less than 0.05 will be considered statistically significant.

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 60.00 Year(s)(—)
性别
All

入选标准

  • American Society of Anaesthesiologists (ASA) physical status I or II
  • Mallampati class I and II.

排除标准

  • Patients with active infections or burns over the neck
  • Pregnant females
  • Patients with suspected or diagnosed cervical spine instability
  • Patients with Mallampati class III or IV, limited mouth opening of less than 2.5 cm, thyromental distance less than 6 cm, Temporo-mandibular joint dysfunction
  • Patients with congenital upper airway anomalies
  • Patients with body mass index (BMI) more than 30 kg per m2
  • Patients undergoing head and neck surgeries requiring throat pack
  • Patients requiring rapid sequence induction of anaesthesia and endotracheal intubation.

研究者

申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Gracy Chanu Ningombam

Regional Institute of Medical Sciences

研究点 (1)

Loading locations...

相似试验