Comparison of intubating conditions in supine(sniffing) and 25 degree back up position using channelled and non channelled video-laryngoscopes- A prospective randomized controlled study
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Modified Difficult Intubation Scale(mIDS)
研究概览
简要总结
After thorough pre-anaesthetic evaluation and 10 hours of nil by mouth, informed written consent will be taken from the patient. After taking patient inside the operation theatre, multipara monitor will be attached and baseline vital parameters including pulse rate, blood pressure and spo2 will be noted.
Patient position: Patient will be given either supine(sniffing) position or 25 degree back up position according to their respective study groups. Supine position will be achieved by keeping 7 cm high non-compressible pillow under the head of the patient.
25 degree back up position will be achieved by raising the operating table to 25 degree from horizontal by flexion of the torso at the hips using the controls on the operating table so that sternal notch and external auditory meatus will be at the same level.
Grouping of the patients: The study population will be randomly allocated into four groups by using sealed envelope method.
Group M1: McGrath video-laryngoscope will be used in supine position. Group M2: McGrath video-laryngoscope will be used in 25 degree back up position.
Group K1: King Vision video-laryngoscope will be used in supine position. Group K2: King Vision video-laryngoscope will be used in 25 degree back up position.
Premedication: Inj. Glycopyrrolate 5mcg/kg IV, Inj. Tramadol 2mg/kg IV, Inj. Ondansetron 0.1mg/kg IV will be given 5 minutes before induction.
Induction: Patient will be pre-oxygenated with 100% o2 for 3 minutes. Then Inj. Lignocaine 1.5mg/kg IV f/b Inj. Propofol 2mg/kg IV till loss of eye lash reflex will be given. After check ventilation, Inj. Suxamethonium Chloride 2 mg/kg IV will be given. After disappearance of fasciculations, patient will be intubated with respective devices and first effective ventilation will be confirmed by capnography. Inj. Vecuronium bromide 0.1mg/kg loading dose will be given.
Methods of endotracheal intubation: Group M1: Patient’s head will be kept in supine position and will be intubated using McGrath video-laryngoscope. Group M2: Patient will be given 25 degree back up position and will be intubated using McGrath video-laryngoscope. Group K1: Patient’s head will be kept in supine position and will be intubated using King Vision video-laryngoscope. Group K2: Patient will be intubated using King Vision video-laryngoscope in 25 degree back up position.
Modified difficult intubation scale(mIDS), Intubation time, Number of attempts of intubation, vital parameters and airway complications ( desaturation, bronchospasm, oropharyngeal trauma, oesophageal intubation) if any will be noted. Maximum 2 attempts with the selected video-laryngoscope will be allowed. Failed intubation will be defined as an attempt in which patient could not be intubated even with optimization manoeuvre or more than 120 secs required to perform the procedure.
Maintenance: 02 +N2O(50:50) with sevoflurane and vecuronium bromide 0.02mg/kg IV
At the end of procedure, patient will be extubated after fulfilling the criteria for extubation and will be shifted to PACU.
| Parameter Group M1 |
Group M2
Group K1
Group K2
|Modified Intubation Difficulty Scale(mIDS)
| PARAMETERS |
GROUP M1
GROUP M2
GROUP K1
GROUP K2
|Intubation Time
|No. of Attempts of device insertion/Intubation
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •ASA â… and â…¡ Mouth opening ≥ 3cm Mallampati grading 1 and 2.
排除标准
- •Patient not willing for participation Patients with difficult airway Morbid obesity(BMI >35) Oral cavity surgeries Pre-existing tracheal or laryngeal pathology Patients requiring rapid sequence intubation Pregnancy.
结局指标
主要结局
Modified Difficult Intubation Scale(mIDS)
时间窗: Modified Difficult Intubation Scale will be assessed at 0 minute
次要结局
- 1.Intubation time(2.Number of attempts of intubation)