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临床试验/CTRI/2017/10/010157
CTRI/2017/10/010157已完成不适用

Comparison of hemodynamic responses to laryngoscopy and tracheal intubation using Macintosh and AirtraQ® laryngoscope in patients with simulated cervical spine injury

NA1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2013年10月15日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
NA
入组人数
60
试验地点
1
主要终点
The outcome variables of heart rate (HR), systolic blood pressure (SBP), and diastolic blood pressure (DBP) mean arterial pressure (MAP) will be recorded

研究概览

简要总结

Laryngoscopyand tracheal intubation are associated with varied levels of sympatheticstimulation. The accompanying increase in heart rate and blood pressure canhave deleterious effects. Patients with cardio vascular compromise, elderly,neurological insult requires measures to curb or avoid these changes. Variouspharmacological agents have been used to blunt the fluctuations in hemodynamicparameters. The choice of airway equipment can also play a role in the severityof sympathetic stimulation to laryngoscopy and intubation. There is mechanicalstretch and stimulation of structures of the airway during laryngoscopy. Themagnitude of cardio vascular response is related to the force and duration oflaryngoscopy. The alterations in hemodynamic parameters have deleteriouseffects on patient physiology and is best avoided or attenuated.Most oftenpatients after trauma have associated head injury. This subgroup requiresmaintenance of hemodynamic and intracranial pressure. However not many studieshave compared the difference with respect to hemodynamic changes among variousairway equipments. [1]The AirtraQ® is a novelintubation device that has been developed to facilitate tracheal intubation inpatients with normal or difficult airways. The blade of the AirtraQ**®**consists of two side byside channels. One channel acts as a conduit through which a tracheal tube(ETT) can be passed, whilst the other channel contains a series of lenses,prisms and mirrors that transfers the image from the illuminated tip to aproximal viewfinder, giving a high quality wide-angle view of the glottis andsurrounding structures, and the tip of the tracheal tube.[2]

Patients with suspected cervical injury requiringintubation depend on such airway device as alignment between oral, pharyngealand laryngeal axes are not required. Macintosh laryngoscope blade is still themost widely used airway device also being used in patients needing manual inline stabilization. Thus we wish to compare these two devices for use inpatients with simulated cervical spine injury with respect to the hemodynamicfluctuations produced in each of them.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Participant, Investigator and Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Patients in 18 to 60 year age group, weighing 40 to 70kg, belonging to ASA PS 1 or 2, scheduled for elective surgery under general anaesthesia requiring tracheal intubation, systolic blood pressure <140mm Hg and diastolic blood pressure <90mmHg on preoperative assessment.

排除标准

  • 1.Hypertension/Hypotension 2.Ischaemic heart disease 3.Anticipated difficult airway 4.Pregnancy or lactation 5.Signs and symptoms of raised intracranial pressure 6.Head injury 7.Cervical spine disease
  • BMI>30kg/m2
  • 2nd or 3rd degree heart block 10.Risk of gastric aspiration 11.Reactive airway disease 12.Patients on drugs affecting blood pressure/HR.

结局指标

主要结局

The outcome variables of heart rate (HR), systolic blood pressure (SBP), and diastolic blood pressure (DBP) mean arterial pressure (MAP) will be recorded

时间窗: Pre-induction Baseline value | 1 minute before intubation | At intubation and 4.Every minute for five minutes after intubation

次要结局

  • Duration of Intubation(Intubation Attempt)

研究者

发起方
NA
申办方类型
Other [na]

研究点 (1)

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