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CTRI Number  CTRI/2017/03/008092 [Registered on: 15/03/2017] Trial Registered Retrospectively
Last Modified On: 14/03/2017
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Medical Device
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparison of video laryngoscope and conventional laryngoscopes for tracheal intubation using cervical collar 
Scientific Title of Study   Airtraq Video Laryngoscope versus Macintosh Laryngoscope for tracheal intubation using cervical collar 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
U1111-1179-7342  UTN 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DrAditi ADhimar 
Designation  Assistant Professor 
Affiliation  Medical College and S.S.G.Hospital, Vadodara 
Address  Department of Anaesthesiology, Medical College and S.S.G.Hospital, Vadodara.

Vadodara
GUJARAT
390001
India 
Phone  0265-2424848  
Fax  0265-2421056  
Email  dhimaraditi@yahoo.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Suni Valand 
Designation  IInd year resident 
Affiliation  Medical College and S.S.G.Hospital, Vadodara 
Address  Department of Anaesthesiology, Medical College and S.S.G.Hospital, Vadodara.

Vadodara
GUJARAT
390001
India 
Phone  0265-2424848  
Fax    
Email  valand_sunil@yahoo.com  
 
Details of Contact Person
Public Query  
Name  DrAditi ADhimar 
Designation  Assistant Professor 
Affiliation  Medical College and S.S.G.Hospital, Vadodara 
Address  Department of Anaesthesiology, Medical College and S.S.G.Hospital, Vadodara.

Vadodara
GUJARAT
390001
India 
Phone  0265-2424848  
Fax  0265-2421056  
Email  dhimaraditi@yahoo.in  
 
Source of Monetary or Material Support  
Medical College and S.S.G.Hospital, Vadodara 
 
Primary Sponsor  
Name  Medical College and SSGHospital 
Address  Medical College and S.S.G.Hospital, Vadodara 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Aditi A Dhimar  Medical College and S.S.G.Hospital, Vadodara.  Department of Anaesthesiology, Medical College, Vadodara.
Vadodara
GUJARAT 		 09825334605

dhimaraditi@yahoo.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee for Human Research  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  All those patients who comes under ASA physical status I and II.,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Airtraq Video Laryngoscope  Patients to intubate using Airtraq Video Laryngoscope 
Comparator Agent  Macintosh Laryngoscope  Patients to intubate using Macintosh Laryngoscope 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  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. 
 
ExclusionCriteria 
Details  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
 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
A.To assess tracheal Intubation profiles by observing
1. Intubation time
2. Intubation Difficulty score 		 seconds 
 
Secondary Outcome  
Outcome  TimePoints 
2.To observe hemodynamic parameters
3. To observe complications if any 		 before induction, after Dexmeditomidine, after induction and intubation and at 3, 5, 7 and 10 minutes after intubation and throughout the period of anaesthesia at 20 minutes interval. 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   24/02/2017 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
Publication Details   none yet  
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

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

·   Macintosh laryngoscope is still considered the gold standard for endotracheal intubation since it was first used in 1943. However, many anesthesiologists are reluctant to use this device in cervical trauma 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 handle difficult intubation and with time they become regular for management of the normal airways.

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

  Primary Objectives: To assess tracheal intubation profiles by observing 

1.     Intubation Time: defined as time from removal of face mask for intubation to connection of anesthesia circuit to endotracheal tube.

2.     Intubation difficult score.

Secondary Objectives:·         To observe hemodynamic parameters.To see airway trauma and complications.

Ø    Interventions and its Methods. All patients will be receiving 

Ø    Premedication in the form of 

·       Inj Glycopyrrolate 0.2mg IM (at the time of  induction)

·       Inj Dexmeditomedine 1 µg/kg IV (at the time of induction).

·       Inj Ondansetron 4 mg IV.

·       Inj Tramadol 1 mg/kg

Ø    Grouping of  patients :

            The patients will be randomly allocated into two groups of 30 patients each by envelope method.

q    Group AVL(n=30) : patients to intubate using  AIRTRAQ video laryngoscope.

q    Group ML(n=30): patients to intubate using  MACINTOSH laryngoscope.


Induction:

·       Pre oxygenation to be done with 100% oxygen for 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 minutes with O2 + N2O 50: 50.

·       Application of semi rigid cervical collar

Laryngoscopy and intubation as per the group randomization.

Ø For the group AVL: Airtraq will be loaded with ETT size 7.5mm for female and 8.5mm for male. All patients will be intubated by Inventor’s Technique.

Ø  For the group ML: Macintosh Laryngoscope will be used and intubation with ETT size 7.5mm for female and 8.5mm for male.

Ø  REVERSAL :

·       At the end of surgery, Nitrous oxide  and anesthetic agents to be stopped. Patients to be ventilated with 100% oxygen. Reversal of residual neuromuscular blocked to be done once patients start spontaneous breathing with the following agents.

            Inj Neostigmine 50µg/kg IV

            Inj Glycopyrrolate 10µg/kg IV.

            During this period, patients will be ventilated with 100% oxygen with fresh gas flow of 8 litres/min. Trachea will be extubated when regular spontaneous breathing become established. Patients is able to open  eyes on command. Patients will be shifted to Post anesthesia care unit.

·                     Patients will be observed for post operative complications.

Ø MONITORING:

Ø  Intubation Time :

Ø  Intubation Difficulty Score (IDS) :

Ø  Hemodynamic parameters are like heart rate ,systolic and diastolic blood pressure, and oxygen saturation before induction, after Dexmeditomidine, after induction and intubation and at 3, 5, 7 and 10 minutes after intubation and throughout the period of anaesthesia at 20 minutes interval.

q    IDS score is the sum of the following seven variables.

§  N1  Number of intubation attempts >1

§  N2  Number of operators >1

§  N3 Number 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) 

•          Intubation Difficulty 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 entire laryngeal aperture

·  Grade 2 Visualization of only posterior commissure of laryngeal aperture

·  Grade 3 Visualization of only epiglottis

·  Grade 4 Visualization of just the soft palate

 

 

 
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