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临床试验/CTRI/2025/10/095650
CTRI/2025/10/095650尚未招募2/3 期

Comparison Of TAScope And McCoy Laryngoscope For Endotracheal Intubation In Patients With Cervical Spine Immobilisation A Prospective Randomised Study

Saptagiri Institute of Medical sciences1 个研究点 分布在 1 个国家目标入组 110 人开始时间: 2025年10月30日最近更新:

试验速览

阶段
2/3 期
状态
尚未招募
发起方
入组人数
110
试验地点
1
主要终点
Will be assessed for difficult intubation based on intubation difficulty scale(IDS). It’s quantitative scale of seven variables assessing the complexity of tracheal intubation. An IDS of zero is best, IDS of 1-5 is slightly difficult, IDS of greater than 5 is moderate to major difficulty.

研究概览

简要总结

Need for study:

Cervical spine injury is present in around 3.7% of trauma victims and approximately 42% of these patients have unstable cervical spine. Minimizing movement with a cervical collar or by manual-in-line stabilisation  becomes necessary in such cases. This makes laryngoscopy and tracheal intubation using conventional McCoy laryngoscope more difficult. Videolaryngoscopes have the advantage of containing miniature video cameras that provide indirect glottic view without requiring oral, pharyngeal and laryngeal axes alignment[1].

 The management of acute spinal cord injury is a multidisciplinary effort. Therefore, the care pathway of trauma patients should emphasise prevention of secondary injuries to the cervical spine in particular. Tracheal intubation with simultaneous immobilization of the cervical spine is the recommended airway management strategy in cases of respiratory failure in trauma patients. Inadequate immobilization of the neck during intubation may result in a poor neurological outcome. Minimizing movement with a cervical collar or by manual-in-line stabilisation  becomes necessary in such cases. Videolaryngoscopes have the advantage of containing miniature video cameras that provide indirect glottic view without requiring oral, pharyngeal and laryngeal axes alignment[2].

 TAScope is an indigenously designed video laryngoscope which is a channeled and anatomically angulated video intubating aid with an endoscopic camera that can be connected to mobile phones and tablets.There are no documented studies comparing TAScope and McCoy for endotracheal intubation in patient with cervical spine immobilisation[3].

 The aim of the study is to Compare of TAScope and McCoy laryngoscope for endotracheal intubation in patients with cervical spine immobilization in terms of difficulty of intubation,based on intubation difficulty  scale,timing for successful intubation and haemodynamic response.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • 1.Age 18 to 65 years 2.Patient willing to give informed consent 3.ASA(American society of anesthesiologists) grade 1 and 2 4.BMI of less than or equal to 30 kg/m² 5.Patients undergoing elective surgical procedures under general anaesthesia with endotracheal intubation
  • Mallampati grade I and II.

排除标准

  • Patients with difficult intubation and suspected difficult airway as assessed in pre-anaesthetic evaluation
  • Patients with cervical instability
  • Pregnant and lactating females
  • Patients with hemodynamic and respiratory co- morbidities.

结局指标

主要结局

Will be assessed for difficult intubation based on intubation difficulty scale(IDS). It’s quantitative scale of seven variables assessing the complexity of tracheal intubation. An IDS of zero is best, IDS of 1-5 is slightly difficult, IDS of greater than 5 is moderate to major difficulty.

时间窗: Will be assessed base line haemodynamic parameters | Before intubation then immediately after intubation at T0 seconds Then after 2 minutes at 4 minutes at 6 minutes at 8 minutes and at 10 minutes

次要结局

  • Hemodynamic parameters Heart rate, Blood pressure, mean arterial pressure, peripheral oxygen saturation at baseline(B), before intubation (BI) immediately after intubation (T0) and later at 2,4,6,8,10 Mins will be noted.(baseline(B), before intubation (BI) immediately after intubation (T0) and later at 2,4,6,8,10 Mins will be noted.)

研究者

发起方
Saptagiri Institute of Medical sciences
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Dr Ravikumar

Sapthagiri Institute of Medical Sciences and Research Centre

研究点 (1)

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