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临床试验/CTRI/2025/07/092091
CTRI/2025/07/092091尚未招募不适用

COMPARISON OF VIDEO LARYNGOSCOPE AND CONVENTIONAL LARYNGOSCOPE FOR ENDOTRACHEAL INTUBATION IN ADULTS WITH CERVICAL SPINE IMMOBILISATION

Dr Mahesh MJ1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2025年8月15日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
150
试验地点
1
主要终点
Evaluate the first-attempt success rate in seconds for endotracheal intubation between conventional

研究概览

简要总结

Study Design and Methodology****Participants Adult patients aged 18 to 65 years undergoing elective surgery under general anaesthesia requiring endotracheal intubation will be enrolled provided they meet the inclusion criteria Informed written consent will be obtained from all participants prior to enrolment

Randomization Patients will be randomly allocated into two groups using a computer generated randomisation table

  • Group V Video Laryngoscope Group
  • Group C Conventional Laryngoscope Group

Preoperative Assessment All patients will undergo a thorough airway examination including

  • Mallampati grading
  • Mouth opening
  • Thyromental distance
  • Neck circumference

Relevant clinical history will also be recorded Standard preoperative fasting guidelines and ASA monitoring protocols will be followed

Anaesthetic Management A standardized general anaesthesia protocol will be followed for both groups Monitoring will include

  • Electrocardiography ECG
  • Heart Rate HR
  • Oxygen Saturation SpO2
  • Non Invasive Blood Pressure NIBP cycled every 1 minute for 5 minutes post laryngoscopy and intubation

Baseline Parameters Baseline values of Systolic Blood Pressure SBP Diastolic Blood Pressure DBP Mean Arterial Pressure MAP HR and SpO2 will be recorded

Induction Protocol

  • Injection Fentanyl 15 mcg per kg IV
  • Injection Propofol 1 to 2 mg per kg IV titrated to loss of verbal response
  • After confirming adequate ventilation Injection Vecuronium 01 mg per kg IV will be administered
  • Patients will be ventilated for 3 minutes with 100 percent oxygen and Sevoflurane 2 to 3 percent to achieve a MAC of 08 to 10

Airway Management Cervical spine immobilization will be performed using manual inline stabilization MILS to prevent neck movement Patients will then be intubated using

  • Group V Video laryngoscope
  • Group C Conventional laryngoscope with an appropriate blade size

All intubations will be performed by experienced anaesthesiologists not residents The number of attempts for successful intubation will be recorded

Outcome Measures

Primary Outcome

  • Time to successful intubation from laryngoscope insertion to confirmation by five point auscultation or appearance of ETCO2 trace

Unsuccessful intubations will be recorded as failures for the respective group and these patients will be excluded from hemodynamic data analysis

Use of adjuncts such as stylet bougie and BURP manoeuvre will be documented

Secondary Outcomes Hemodynamic parameters including HR SBP DBP and MAP will be recorded noninvasively at 1 3 and 5 minutes post laryngoscopy

Severe stress responses requiring pharmacological intervention will be noted

Adverse events such as

  • Desaturation SpO2 less than 93 percent
  • Failed or oesophageal intubation
  • Injuries to lips tongue teeth or oral cavity
  • Any other complications

will be recorded

Both groups will proceed with standard general anaesthesia protocols post intubation

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 60.00 Year(s)(—)
性别
All

入选标准

  • Adult patients aged 18 to 60 years.
  • Patients classified as ASA Physical Status I and II.
  • Patients scheduled for elective endotracheal intubation under general anaesthesia.

排除标准

  • Patients with known severe airway deformity, restricted mouth opening, upper airway tumours, or anticipated difficult airway (Mallampati Class III & IV).
  • Patients who are on beta blockers or calcium channel blockers.

结局指标

主要结局

Evaluate the first-attempt success rate in seconds for endotracheal intubation between conventional

时间窗: Evaluate the first-attempt success rate in seconds for endotracheal intubation between conventional | laryngoscope and video laryngoscope in patients with cervical spine immobilization.

laryngoscope and video laryngoscope in patients with cervical spine immobilization.

时间窗: Evaluate the first-attempt success rate in seconds for endotracheal intubation between conventional | laryngoscope and video laryngoscope in patients with cervical spine immobilization.

次要结局

  • Determine the number of intubation attempts.(Measure the time taken for successful intubation.)

研究者

发起方
Dr Mahesh MJ
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Mahesh MJ

Command Hospital (Air Force), Bengaluru

研究点 (1)

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