A Comparative study of the Effects of Different Types of Laryngoscopes on the Cervical spine Motion using an inclinometer : Randomised clinical trial.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- To compare the degree of cervical spine motion indirectly measured
研究概览
简要总结
Study patients are adults undergoing elective surgery under
general anaesthesia requiring endotracheal intubation. The enrolled patients will be divided in
to four groups Group-1,2,3,4 in which patients will be intubated with mc-intosh
Laryngoscope, cmac, mcgrath, BPL respectively. Patients will be allocated to specific group
through random number generated through computer in a sealed envelopes technique.
Routine preoperative anaesthetic check up and optimization, if needed will be done.
Once patients will be taken into the operation theater, standard preinduction monitors such as
electrocardiograms, pulse oximetry, non-invasive BP monitoring.
Intravenous access will be obtained with a 18G or 20G cannula
under strict aseptic conditions .Now patient made to supine
position and preoxygenation is done with 100% oxygen for 3
minutes. All patients will receive glycopyrrolate (1µg/kg body
weight), fentanyl (2 µg/kg) as premedication. Following which
patient will be given induction with propofol and inhalational
agent. Each patient lay supine on a flat level operating table, the
inclinometer is placed on forehead and neck straightened till it is
horizontal to the floor . Standard mask ventilation procedure will
be followed with 2 hand technique. Intubation will be attempted
with laryngoscopes allotted in each group with as minimal neck
movement as possible. . Inclinometer angle will be measured at
five points 1. At neutral before induction, 2. Before mask
ventilation, 3. At point of successful mask ventilation, 4. Best
glottic view, 5. At the pot of et insertion. Also hans scale for mask
ventilation, CL grading, and Intubation Difficulty Scale (IDS)
scores were assessed and recorded for all patients.Therefore,
neutral position was applied to the head before the laryngoscopy.
In this procedure, the head was stabilized as the infraorbital edge
and tragus is perpendicular to the ground.An inclinometer (a 360
degree angle gauge) was placed on the forehead of the patients, so
that the tip of the inclinometer fit the glabellar line The inner
diameters of the intubation tubes used for females and males were
7 to 7.5 mm and 8 to 8.5 mm, respectively(2). The maximum angle of
cervical extension was measured by an inclinometer. The head was
neutrally positioned and the degree that the inclinometer showed
was recorded. Then, the maximum degree shown by the inclinometer
during laryngoscopy and tracheal intubation was recorded. The
maximum angle of cervical extension was measured by subtracting
the first and last recorded degree(2). An IDS score (3) of IDS 0
=(easy intubation) IDS 1 to 5 suggests (slight difficulty), and IDS
≥5 denotes a (difficult intubation).The duration from the
laryngoscope blade passing the lips and the placement of the tube
into trachea is recorded as the intubation process time (IPT).If the
IPT was more than 120 seconds, the patients will be ventilated for 1
minute with a face mask, and then intubation will be performed
using a fiberoptic laryngoscope for unsuccessful ones(2) . Those
patients will be excluded from the study. Finally, all of the
patients will be intubated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)(—)
- 性别
- All
入选标准
- •Written valid consent, ASA 1-2, Age 18-65 yrs, Mallampati grade 1-2.
排除标准
- •BMI more than 30, predicted difficult airway, previous neck surgery or abnormal airway morphology, clinical and radiographic suspicion of cervical spine abnormality, mouth opening less than 2 fingers.
结局指标
主要结局
To compare the degree of cervical spine motion indirectly measured
时间窗: At neutral position and during best glottic view. study will end after the position of endotracheal tube is confirmed. this will be around 10-15 mins after induction of general anaesthesia.
through an inclinometer at best glottic view during intubation with different laryngoscopes.
时间窗: At neutral position and during best glottic view. study will end after the position of endotracheal tube is confirmed. this will be around 10-15 mins after induction of general anaesthesia.
次要结局
- to compare the degree of cervical spine motion during successful(mask ventilation,)
- the incidence of difficult endotracheal tube insertion at the best glottic(view)
- Intubation Difficulty Score in different laryngoscopes(Immediately after intubation with endotracheal tube)
- To compare duration of intubation with different laryngoscopes(immediately after successful endotracheal intubation)
研究者
Mukesh R
Nizam’s Institute of Medical Sciences
