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临床试验/CTRI/2017/03/008092
CTRI/2017/03/008092进行中(未招募)不适用

Airtraq Video Laryngoscope versus Macintosh Laryngoscope for tracheal intubation using cervical collar

Medical College and SSGHospital1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2017年2月24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
60
试验地点
1
主要终点
1. Intubation time

研究概览

简要总结

·    Airway management is a main responsibility ofthe anesthesiologists as difficult or unsuccessful tracheal intubation is oneof the important causes for morbidity and mortality in susceptible patients.

·   Macintosh laryngoscope is still consideredthe gold standard for endotracheal intubation since it was first used in 1943.However, many anesthesiologists are reluctant to use this device in cervicaltrauma due to potential for neurological injury.

·  Nowadays, due to the advances in technology,new video laryngoscopic devices became available.  The devices are originally designed to handledifficult intubation and with time they become regular for management of thenormal airways.

Goalof our study is to use Airtraq video laryngoscope   in patient with normal airway but neck isimmobilized using rigid cervical collar simulating cervical spine injury.

Primary Objectives: To assess tracheal intubationprofiles by observing

  1.     Intubation Time: defined astime from removal of face mask for intubation to connection of anesthesiacircuit to endotracheal tube.

  2.     Intubation difficult score.

**SecondaryObjectives:**·        Toobserve hemodynamic parameters.To see airway trauma and complications.

Ø   Interventions and its Methods. All patients will be receiving Ã˜   Premedication in the form of Â·       Inj Glycopyrrolate 0.2mg IM (at thetime of  induction) ·       Inj Dexmeditomedine 1 µg/kg IV (at thetime of induction).·       Inj Ondansetron 4 mg IV.·       Inj Tramadol 1 mg/kgØ   Grouping of  patients :            The patients will be randomly allocated into two groups of 30patients each by envelope method.q    Group AVL(n=30) : patients to intubateusing  AIRTRAQ video laryngoscope.q    Group ML(n=30): patients to intubateusing  MACINTOSH laryngoscope. Induction:·       Pre oxygenation to be done with 100% oxygenfor 3 min with Bain’s circuit.·       Inj Propofol 2-2.5  mg /kg  IV  till   loss  of eyelid  reflex.·       Inj Vecuronium bromide 0.1mg/kg IV.·       IPPV by Bain’s circuit for 3 minuteswith O2 + N2O 50: 50.·       Application of semi rigid cervicalcollar

Laryngoscopy and intubation as per thegroup randomization.Ø For the group AVL: Airtraq will beloaded with ETT size 7.5mm for female and 8.5mm for male. All patients will be intubatedby Inventor’s Technique.Ø  For the group ML: Macintosh Laryngoscope willbe used and intubation with ETT size 7.5mm for female and 8.5mm for male.

Ø  REVERSAL :·       At the end of surgery, Nitrousoxide  and anesthetic agents to bestopped. Patients to be ventilated with 100% oxygen. Reversal of residual neuromuscularblocked to be done once patients start spontaneous breathing with the followingagents.            Inj Neostigmine50µg/kg IV            Inj Glycopyrrolate10µg/kg IV.            During this period, patients will be ventilated with 100%oxygen with fresh gas flow of 8 litres/min. Trachea will be extubated whenregular spontaneous breathing become established. Patients is able to open  eyes on command. Patients will be shifted toPost anesthesia care unit.·                    Patientswill be observed for post operative complications.

Ø MONITORING:Ø  Intubation Time :Ø  Intubation Difficulty Score (IDS) :Ø  Hemodynamic parameters are like heartrate ,systolic and diastolic blood pressure, and oxygen saturation before induction, after Dexmeditomidine, afterinduction and intubation and at 3, 5, 7 and 10 minutes after intubation andthroughout the period of anaesthesia at 20 minutes interval.

q    IDS score is the sum of the followingseven variables.§  N1  Number of intubation attempts >1§  N2  Number of operators >1§  N3Number of alternative intubation techniques used (n)§  N4 Glottic exposure(Cormack and Lehane grade _1) (n-1)§  N5  Lifting force required during laryngoscopy(0= normal; 1=increased)§   N6 Necessity for external laryngeal pressure (0=not applied; 1=applied)§   N7 Position of the vocal cords at intubation(0=abduction/not Visualized) (1=adduction)  •         IntubationDifficulty Score      Intubation quality•         IDS= 0                     Easy•         IDS= 1-5                  Moderately difficult•         IDS= > 5                  Very difficult to impossible

•            The Cormack and Lehane grade at laryngoscopy.•  Grade 1 Visualization of the entirelaryngeal aperture·  Grade2 Visualization of only posterior commissure of laryngeal aperture·  Grade3 Visualization of only epiglottis·  Grade4 Visualization of just the soft palate

研究设计

研究类型
Interventional
分配方式
Other
盲法
Open Label

入排标准

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

入选标准

  • 1.ASA status I and II.
  • 2.Patients posted for elective surgery requiring general anaesthesia and Endotracheal Intubation.
  • 3.Patients willing to participate in the study.

排除标准

  • 1.Cervical spine injury 2.Anticipated difficult intubation 3.Thyromental distance <6 cm 4.Inter-incisor gap <3 cm
  • Sterno-mental distance <12 cm 6.Neck circumference >42 cm
  • Pregnant and obese patients
  • At risk of gastric aspiration
  • Mallampati grade III or IV.

结局指标

主要结局

1. Intubation time

时间窗: seconds

2. Intubation Difficulty score

时间窗: seconds

A.To assess tracheal Intubation profiles by observing

时间窗: seconds

次要结局

  • 2.To observe hemodynamic parameters(3. To observe complications if any)

研究者

发起方
Medical College and SSGHospital
申办方类型
Government medical college

研究点 (1)

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