COMPARISON OF VIDEO LARYNGOSCOPE AND CONVENTIONAL LARYNGOSCOPE FOR ENDOTRACHEAL INTUBATION IN ADULTS WITH CERVICAL SPINE IMMOBILISATION
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
Dr Mahesh MJ
Command Hospital (Air Force), Bengaluru
