跳至主要内容
临床试验/CTRI/2025/09/094457
CTRI/2025/09/094457尚未招募3 期

The effect of Flexible tip Bougie vs. Stylet on Cervical Spine Motion during video laryngoscopic intubation under Manual Inline Stabilisation: A Randomized controlled trial.

Department of Anesthesiology and Critical care, AIIMS , Bhubaneswar1 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2025年10月1日最近更新:

试验速览

阶段
3 期
状态
尚未招募
发起方
入组人数
52
试验地点
1
主要终点
Difference in cervical spine motion- in degrees at the Occiput–C1 segment.

研究概览

简要总结

Cervical spine motion , particularly at the Occiput–C1 segment, has a risk of neurological deterioration during tracheal intubation in patients with cervical spine pathology. In order to minimize this risk, Manual In-Line Stabilization or cervical collars are routinely employed. Both the techniques reduce cervical motion at the cost of making the airway management difficult. Video laryngoscopy is increasingly preferred over Fiberoptic Bronchoscopy (FOB) due to comparable cervical spine safety and higher first-pass success rates. However, intubation often requires adjuncts such as stylet or bougie, each with its own mechanical profiles. Studies comparing the efficacy of stylet and bougie on the intubation success rate are present. However, the effect of bougie and stylet on cervical spine motion remains unstudied.  Both glottic exposure and tube advancement contribute to cervical spine motion. This study aims to fill this gap by comparing cervical spine motion during videolaryngoscopy (VDL) -guided intubation using a Flexible tip bougie and a Stylet under Manual In-Line Stabilization (MILS). The findings will aid anaesthesiologists in selecting lower-risk intubation techniques for patients with cervical spine instability and may help inform future airway management guidelines. This randomized  controlled trial is designed to compare the cervical spine movement during videolaryngoscopy guided intubation using either a flexible tip bougie or a stylet in patients undergoing cervical spine surgery or neurointerventional procedures under general anesthesia, with the hypothesis that flexible tip bougie guided intubation results in lesser cervical spine motion.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant and Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • Patients scheduled for cervical spine surgery or Neuro intervention procedures.
  • ASA grade 1,2 and 3 patients.

排除标准

  • Oral tumours Airway bleed Pregnant Children Hemodynamic instability Mouth opening less than 2.5 cm.

结局指标

主要结局

Difference in cervical spine motion- in degrees at the Occiput–C1 segment.

时间窗: T1 is Baseline | T2 is during videolaryngoscopy with a POGO score of atleast 50% | T3 is during endotracheal tube advancement. | Cervical spine motion at T2 and T3 is compared with T1.

次要结局

  • 1.Cervical spine motion at:(C1–C2 segment & C2–C5 segment.)

研究者

发起方
Department of Anesthesiology and Critical care, AIIMS , Bhubaneswar
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Priyanka

AIIMS Bhubaneswaer

研究点 (1)

Loading locations...

相似试验

Comparison of two airway adjuncts in airway tube... | 临床试验