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临床试验/CTRI/2024/04/065456
CTRI/2024/04/065456尚未招募2 期

Comparison between C-MAC video laryngoscope versus fibreoptic bronchoscope for awake intubation under ketofol-ketamine plus propofol sedation in cervical spine injury: immobilised with cervical collar: Prospective Randomized Controlled trial”

Dr. Thalishetti Yugala1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年4月18日最近更新:

试验速览

阶段
2 期
状态
尚未招募
发起方
入组人数
60
试验地点
1
主要终点
To compare the success of intubation in first attempt with C-MAC video laryngoscope versus fibreoptic bronchoscope for awake intubation under ketofol sedation in cervical spine injury: immobilised with cervical collar

研究概览

简要总结

In patients with cervical spine injury, airway management poses a bigger challenge due to risk of neurological damage related to neck movements thus manual in line stabilization or cervical collar is commonly applied to minimise neck movements, such immobilisation can render intubation under direct laryngoscopy more difficult.

Securing the airway without cervical spine movement to avoid any neurological catastrophe is always an anaesthetic challenge. These issues have prompted the development of number of alternatives to Macintosh laryngoscope such as C-MAC, fibre optic, McCoy laryngoscope, intubating laryngeal mask airway, C-Trach and Bullard laryngoscope.

Awake fibre optic bronchoscope intubation is gold standard in cervical spine injury, but its time consuming and requires more psychomotor skills and training. The C-MAC  is a nonchannelled video laryngoscope. The primary feature of D blade is its shape, which is an elliptically tapered blade raising to the distal. It claims to provide an easy option in difficult laryngoscopies. Studies have done proving that it is less time consuming and intubation time can be shorter and no separate skills needed for using C-MAC as technique is same as laryngoscope technique and gives ease of intubation. There are no studies comparing C-MAC with fibre optic intubation in traumatic cervical spine immobilised with cervical collar.

We planned this study to compare C-MAC intubation with gold standard fibre optic intubation in traumatic cervical spine. Awake intubation has added advantage in assessing neurological status post intubation and we can have control on airway. In an awake, unprepared patient with excessive salivation, gag and cough reflex can make intubation more challenging. These can be reduced by addition of antisialogogues, and  topicalization of airway with nebulisation with 10% lignocaine and achieving sedation with ketofol because of its profound analgesia and amnesia while maintaining protective airway reflexes, spontaneous respiration along with stabilizing hemodynamic profile and quick recovery. Hence, this study aims to compare the efficacy of  success of intubation in first attempt with C-MAC video laryngoscope versus fibre optic bronchoscope for awake intubation under ketofol (ketamine plus propofol) sedation in cervical spine injury: immobilised with cervical collar.

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 70.00 Year(s)(—)
性别
All

入选标准

  • ASA 1 and 2 patients
  • Patients above 18 years and less than 70 years
  • Patients with BMI less than 30
  • Patients undergoing elective surgeries
  • Patients with traumatic cervical spine injury with neck collar.

排除标准

  • Patient who do not consent for study
  • Patients at risk of aspiration
  • Emergency surgeries
  • Patients with high risk for surgery like cardiac condition
  • Patients with local anaesthetic allergy
  • Patients with delirious symptoms, cognitive dysfunction
  • Patients with other cervical spine diseases.

结局指标

主要结局

To compare the success of intubation in first attempt with C-MAC video laryngoscope versus fibreoptic bronchoscope for awake intubation under ketofol sedation in cervical spine injury: immobilised with cervical collar

时间窗: Time for successful intubation(T1+T2) T1- time for visualisation of glottis | T2- from visualisation of glottis to confirmation of intubation by capnography

次要结局

  • Haemodynamic changes(Heart rate, systolic blood pressure, diastolic blood pressure, mean arterial pressure, saturation at baseline, 5 minutes, 10 minutes before intubation, 0 minutes, 5 minutes, 10 minutes, 15 minutes after intubation)
  • Ease of intubation by Likert scale(1- extremely easy)
  • Ramsay sedation score(1- anxious and agitated or restless or both)

研究者

发起方
Dr. Thalishetti Yugala
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Thalishetti Yugala

Nizams Institute of medical sciences

研究点 (1)

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