Comparison of video laryngoscope and conventional laryngoscopes for tracheal intubation using cervical collar

Active, not recruiting

• Conditions: All those patients who comes under ASA physical status I and II.

• Registration Number: CTRI/2017/03/008092
• Lead Sponsor: Medical College and SSGHospital

Brief Summary

·    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*·  Gra*de4 Visualization of just the soft palate*

Detailed Description

Not available

Study Timeline

• Study Start: 2017-02-24
• Last Update Posted: 2017-03-14

Recruitment & Eligibility

• Status: Closed to Recruitment of Participants
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• 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.

Exclusion Criteria

• 1.Cervical spine injury 2.Anticipated difficult intubation 3.Thyromental distance <6 cm 4.Inter-incisor gap <3 cm 5.
• Sterno-mental distance <12 cm 6.Neck circumference >42 cm 7.
• Pregnant and obese patients 8.
• At risk of gastric aspiration 9.
• Mallampati grade III or IV.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Intubation time	seconds
2. Intubation Difficulty score	seconds
A.To assess tracheal Intubation profiles by observing	seconds

Secondary Outcome Measures

Name	Time	Method
2.To observe hemodynamic parameters	3. To observe complications if any

Trial Locations

Locations (1)

Medical College and S.S.G.Hospital, Vadodara.; 🇮🇳 Vadodara, GUJARAT, India

Medical College and S.S.G.Hospital, Vadodara.

🇮🇳Vadodara, GUJARAT, India

Dr Aditi A Dhimar

Principal investigator

09825334605

dhimaraditi@yahoo.in