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临床试验/CTRI/2018/07/015064
CTRI/2018/07/015064进行中(未招募)不适用

A COMPARATIVE CROSSOVER RANDOMIZED STUDY OF MILLERS AND MACINTOSH BLADE FOR LARYNGOSCOPIC VIEW AND EASE OF INTUBATING CONDITIONS IN ADULTS.

Dr NALINI KB1 个研究点 分布在 1 个国家目标入组 172 人开始时间: 2016年10月15日最近更新:

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
172
试验地点
1
主要终点
LARYNGOSCOPIC VIEW IS BETTER USING MILLER BLADE THEN WITH MACINTOSH BLADE.

研究概览

简要总结

After obtaining institutional ethics committee approval and patients informed consent,patient aged between 18- 65 years, satisfying the inclusion criteria will be enrolled to the study. Patients will be randomized into 2 groups by computer generated random numbers as,

Group MAC/MIL  and

Group  MIL/MAC.

Following a pre-operative evaluation patients will be kept nil per orally for 6 hours for solids and 3 hours for clear fluids, tablet Ranitidine 150 mg and tablet Ondensetron 4 mg orally with a small sip of water on the morning of surgery. Intravenous access will be secured by IV  cannulation and patient shifted to operation theatre.

Standard monitors likeelectrocardiogram(ECG) lead II, oxygen saturation (SpO2), non-invasive blood pressure (NIBP) will be attached.  Airway assessment once again will be carried out using Mallampatti classification.

The patient will be put in neutral position.The patient will be pre-oxygenated with 100% oxygen for 3 minutes. Anaesthesia will be  induced with 2 mg/ kg of propofol, fentanyl 2 µg/ kg. Feasibility of ventilation with a face mask will be checked prior to injection of  muscle relaxant. After ventilation was confirmed, inj. Atracurrium 0.5mg/kg  willbeadministered and the patient will be ventilated with Iso-flurane 0.5-1% till TOF 0/1.

In the MAC/ MIL group, initial laryngoscopic grading with a Macintosh blade will be noted and then with the Miller blade and vice versa in the MIL/ MAC group. The Macintosh blade will be advanced along the right surface of the tongue and the Miller blade will be advanced along the central surface of the tongue, the tips of both blades being placed in the vallecula. Cook’s modification of CORMACK and LEAHANE grading of the laryngoscopic views will be noted. Optimal external laryngeal manipulation (OELM) will be performed by the laryngoscopist if the grading2a or more and an improvement in laryngoscopic grading will be noted. Following each laryngoscopic attempt, an adequate depth of anaesthesia will be maintained. The patients will be intubated after the second laryngoscopic attempt irrespective of the type of blade. Ease of intubation will be graded as follows,

Ease of intubation grading:

Grade I: Intubation easy

Grade II: Intubation requiring an increased anterior lifting force and assistance to pull the right corner of the mouth upwards to increase space.

Grade III: Intubation requiring multiple attempts

Grade IV: Failure to intubate with assigned laryngoscope .

Visualization of laryngeal inlet (modified CORMACK and LEHANE Grading)

Grade 1: (full view of the vocal cords)

Grade 2A: (partial view of the vocal cords),

Grade 2B: (only the arytenoids and epiglottis seen),

Grade 3: (only epiglottis visible) and

Grade 4: (neither the epiglottis nor glottis seen).

Haemodynamical changes in the patient like NIBP, MAP, SPO2, heart rate, will be documented before induction of anaesthesia, after Induction of anesthesia but before first laryngoscopy,after first laryngoscopy, after second laryngoscopy and 5,10 and 15 minutes after intubation.

Time required for laryngoscopy to view glottis is noted with each blade. The time will begin from insertion of the laryngoscope into the mouth till first glottis view is obtained,

At the end of surgery all patients will receive inj.Ondensteron 4 mg for prevention of post-operative nausea and vomiting, Residual neuro-muscular blockade will be antagonized by inj. Neostigmine 0.05 mg/ kg and inj. Glycopyrrolate 0.01 mg/ kg and extubated once extubation criteria is met.

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

  • 1.American Society of Anaesthesiologist grades I and II for elective surgeries under General anaesthesia.

排除标准

  • 1.Patients who refuse to give consent, 2.Pregnant patients, 3.Patients who are considered full stomach, 4.Patients with anticipated difficult intubation, 5.Previous oral surgeries /oral thrush, pathology in neck, -Ischemic heart disease patients.

结局指标

主要结局

LARYNGOSCOPIC VIEW IS BETTER USING MILLER BLADE THEN WITH MACINTOSH BLADE.

时间窗: At the end of 2years from start of study.

次要结局

  • EASE OF INTUBATION IS BETTER WITH MAC INTOSH BLADE THEN WIYH MILLER BLADE.(6 MONTHS)

研究者

发起方
Dr NALINI KB
申办方类型
Other [self]

研究点 (1)

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