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CTRI Number  CTRI/2019/12/022441 [Registered on: 18/12/2019] Trial Registered Prospectively
Last Modified On: 16/12/2019
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Medical Device
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comaprision of the two different laryngoscopes for tracheal intubation in children 
Scientific Title of Study   Comparsion of the airtarq video laryngoscope vs Macintosh laryngoscope for tracheal intubation in the pediatric patients 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DrRajsi shah 
Designation  2nd year resident 
Affiliation  Medical college and ssg hospital vadodara 
Address  21b jagruti society,opp.gandhi park harni main road, vadodara,
Department of anaesthesiology, medical college and SSG hospital, vadodara, Gujarat
Vadodara
GUJARAT
390022
India 
Phone  9601788011  
Fax    
Email  Rajsishah92@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr kavita lalchandani 
Designation  Associate professor 
Affiliation  Medical college and ssg hospital vadodara 
Address  department of anesthesiology,medical college baroda
Department of anaesthesiology, medical college and SSG hospital, vadodara, Gujarat
Vadodara
GUJARAT
390020
India 
Phone  9274586809  
Fax    
Email  lalchandanikavita@yahoo.co.in  
 
Details of Contact Person
Public Query
 
Name  DrRajsi shah 
Designation  2nd year resident 
Affiliation  Medical college and ssg hospital vadodara 
Address  21b jagruti society,opp.gandhi park harni main road, vadodara,
Department of anaesthesiology, medical college and SSG hospital, vadodara, Gujarat

GUJARAT
390022
India 
Phone  9601788011  
Fax    
Email  Rajsishah92@gmail.com  
 
Source of Monetary or Material Support  
Self 
 
Primary Sponsor  
Name  Government medical college vadodara 
Address  Medical college and ssg 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 rajsi shah  S.S.G hospital  Department of anaesthesiology, medical college and ssg hospital vadodara Gujarat
Vadodara
GUJARAT 
9601788011

Rajsishah92@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee for human reserch  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Airtarq video laryngoscope  Different types available.easy to learn.CSOM camera attached with the device,so airway picture will be displayed on camera.avilable in different sizes.disosable as well as reusable optics also available 
Intervention  Macintosh laryngoscope  Conventional scope.airway stress response.takes more time than video laryngoscope 
 
Inclusion Criteria  
Age From  3.00 Year(s)
Age To  12.00 Year(s)
Gender  Both 
Details  1. pt posted for elective surgery under GA requiring endotracheal intubation
2. age 3-12yrs
3. Asa status l nd ll
4. sex - male nd female 
 
ExclusionCriteria 
Details  1.sore throat
2.URTI
3.pt suffering from respiratory disease that might cause airway narrowing
4.preexisting laryngeal and tracheal pathology
5.lesion that cause airway deformity due to fibrosis
6.anticipated difficult airway
7.patient is not willing 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1.intubation time
2.no. of attempts of device insertion
3.quality of visulization of glottic aperture
4.optimization manevuers reuired for intubation like jaw thrust , external laryngel pressure or using bougie
 
all the four perameters will be seen at the time of intubation 
 
Secondary Outcome  
Outcome  TimePoints 
1.vital parameters like pulse rate,blood pressure,oxygen saturation,EtCO2
2.incidence of airway trauma and complications 
1.to observe at
-baseline
-at the time of induction
-at the time of intubation
-every minute following intubation till 5 minutes
-every 10 minutes thereafter till surgery continues
2.to observe 24 to 48 hours after surgery  
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
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)   26/12/2019 
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="0"
Months="8"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
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 an important aspect of anaesthesia administration. Tracheal intubation is often required in general anaesthesia. Failure to achieve intubation may lead to various complications like inadequate oxygen delivery, hypoxia, aspiration of gastric contents and is one of the important causes of morbidity and mortality in susceptible patients.

For tracheal intubation laryngoscopy is to be done. Macintosh laryngoscope is still considered the gold standard for endotracheal intubation since it was first used in 1943. Its useful in both adults and paediatric patients. Use of this laryngoscope requires a particular morning sniffing position of the patient leading to alignment of three axises(oral, pharyngeal and tracheal). There is movement at atlanto-occipital joint. Hence in cases with cervical vertebrae fractures, it is hazardous to achieve this position. Laryngoscopy by this laryngoscope also requires adequate mouth opening which may not be there in each and every paient. View of the vocal cords is also from distance and we have to keep our eyes near to patients mouth.

In last few years efforts have been made to overcome these problems and to evolve a device which can be used in all such situations where Macinosh laryngoscope is not much helpful. Videolaryngoscope (VL) is developed this way. The device was originally designed to handle difficult intubation but with passage of time these are becoming more common in regular use for laryngoscopy and tracheal intubation in normal airways.

Advantages of videolaryngoscope(VL) are that they can be used in neutral position, view is clear and can be seen on a big screen (no need to keep eyes near to patients mouth) and even in small mouth openings these are helpful. Various types of VLs are now a days available in market. They are mainly with side channel for endotracheal tube or without channel. Commonly used VLs are Airtraque and King vision.

Two types of Airtraq VL are available in which one has reusable optics and disposable channeled blade with rechargeable battery and another one having disposable rigid optical laryngoscope. The blade of the Airtraq consists of two side by side channels, one channel act as a conduit through which endotracheal tube can be passed, while the other channel contains a series of lenses, prisms and mirrors that transfers the image from the illuminated tip to a proximal viewfinder, giving a high quality wide-angle view of the glottis, surrounding structures and the tip of the tracheal tube. A battery powered light source is located on the edge of the blade. It has an anti fog system for optics. It can be connected to the Airtraq Wireless display recorder. The CMOS Camera automatically transmits images by Radiofrequency at 5.8Ghz, making it possible to work wireless when using the Airtraq wireless Display Recorder. The Airtraq Camera is powered by its internal rechargeable battery.

Considering the advantages of Airtraq VL, we wish to carry out this study to evaluate and compare the efficacy of Airtraq video laryngoscope with conventionally used  Macintosh laryngoscope for intubation in pediatric patients posted for elective surgery under general anaesthesia

•      The aims of the study are –

-          To compare Airtraq video laryngoscope with Macintosh laryngoscope in terms of following parameters:

 

 

1.      Intubation Time

2.      No. of attempts of device insertion

3.      Quality of visualization of Glottic aperture

4.      Optimization maneuvers required for intubation

5.      Hemodynamic parameters

6.      Airway trauma and complications

METHODOLOGY

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

a) Study setting –Clinical setting

b) Study population: Patients admitted in SSG hospital and requiring general anaesthesia with endotracheal intubation for planned surgeries.

c)Study duration- From October-2017 to October-2018

d)Study design- Prospective Randomized Controlled Study.

e) Sampling and sample size:
     “Airtraq versus Macintosh laryngoscope in intubation performance in the pediatric population”
Waleed RiadAshraf Moussa,1 and David T. Wong
Department of Anesthesia, Toronto Western Hospital, Canada.
Saudi Journal of Anaesthesia,2012

              
 With reference to the study mentioned above and with the help of nMaster 2.0 software, considering α error=0.05, confidence interval=99% and power=90%, sample size comes to be 30 in each group. We will be taking 30 patients in each group.

f) Inclusion Criteria:

1.      Patients posted for elective surgery under general anesthesia requiring Endotracheal Intubation

2.      Age:3-12yrs

3.      Sex-male/female

4.      Mallampatti grade I & II

5.      ASA I & II

g) Exclusion Criteria:

1.      Sore Throat

2.      URTI (upper respiratory tract infection)

3.      The patient suffering from any respiratory disease that might cause airway narrowing

4.      Preexisting laryngeal or tracheal pathology

5.      Any lesion that could cause airway deformity due to fibrosis

6.      Anticipated difficult airway (mouth opening of < 2cm, Mallampatti class IV, limited neck extension, anatomical abnormality of airway)

7.      Patient not willing for participation.

h) Pre-operative Preparation
            patient to be kept nil by mouth(NBM) for minimum 6-8 hours and Secure iv line


i)Intervention and its method

•      After thorough pre-anesthetic evaluation all the patients falling in the inclusion criteria will be selected and informed written consent will be taken from patient’s guardian(attached separately)

•      Trolley preparation: Cylinders and circuits to be checked, airway equipment and drugs to be kept ready before induction.

•      After taking patient inside the operation theatre, multipara monitor will be attached and baseline vital parameters will be noted.

•      Video laryngoscope preparation:

For Airtraq video laryngoscope, the CMOS camera will be mounted on it and checked by watching the image on the monitor. The tube to be used will be lubricated with lignocaine jelly. The device will be preloaded with appropriate size tube in tube guiding channel and ensured that tube is sliding smoothly through the channel

 

Premedication:

•      Inj. Glycopyrrolate 5 mcq/kg IV (5 min before induction)

•      Inj. Peracetamol 5 mg/kg IV (5 minutes before induction)

•      Inj. Midazolam 0.5 mg IV (5 min before induction)

•      Inj. Ondensatron 0.1 mg/kg IV (5 min. before induction)

 

Grouping Of Patients:

The patients will be randomly allocated into two groups of 30 patients each using ENVELOPE   method.

1)      Group- A

in which Airtraq (pediatric size) will be used for endotracheal intubation

2)  Group- M

in which conventional Macintosh laryngoscope will be used for endotracheal intubation


Induction:

•      Preoxygenation with 100% O2 for 3min

•      Inj. Xylocard 1 mg/kg IV

•      Inj. Propofol 2 mg/kg IV till loss of eye lash reflex.

•      Inj. Suxamethonium Chloride 1.5-2 mg/kg IV given after check ventilation.

•      intubation done by respective devices after disappearance of fasciculations.
All the intubation procedures will be done by Myself.
(I have taken training by doing 10 pilot cases.)

•      Inj. Vecuronium bromide 0.1 mg/kg loading dose.



Method of Endotracheal intubation:

q  Group A (with Airtraq)

•      Patients head will be kept in neutral position.

•      The Airtraq of pediatric size with pre-loaded tube will be advanced from the center of tongue towards the glottis by viewing on the screen of the monitor kept on the side so that it will barely lift the epiglottis with the tip of the blade.

•      Simultaneously with the view of glottis on monitor, tube will be advanced into the trachea under direct observation on the video screen.

•       Selection of size of Airtraq done as per manufactures guidelines.

Airtraq size

ET which can be used

Age group

Pediatric

4,4.5,5,5.5

2-8 years

Adult small

6,6.5,7,7.5

8-15 years

 

 

 

 

q    Group M (with Macintosh)

•      Patient’s head will be kept in morning sniffing position so that oro pharyngeal and tracheal axis will come in alignment.

•      Macintosh laryngoscope of appropriate size will be advanced from right side of the mouth.

MAC blade

Age group

No,2

2-10 years

No.3

10-15 years

 

 

 

 

 

•      Blade will be approached up to base of tounge, and vallecula will be seen.

•      Vallecula will be lifted and through the glottic opening tube will be advanced in the trachea.

 

Maximum 2 attempts with the selected laryngoscope will be allowed.

Failed intubation will be defined as an attempt in which patient could not be intubated even with optimization maneuvers or > 120 secs required to perform the procedures.

In case of failure, the patient will be excluded from the study.

-          Optimization maneuvers required to perform will be assessed on a score of 0 to 2.

o   0-no maneuvers required

o   1-external laryngeal pressure /jaw thrust

o   2-use of bougie

j) Maintenance

Oâ‚‚+Nâ‚‚O (50:50) with sevoflurane and vecuronium bromide 0.02 mg/kg.

 

k) Reversal
               At the end of surgery N2O and anesthetic agent to be stopped before 10 mins and patient to be ventilated with 100% oxygen. Reversal of residual neuromuscular block to be done, once patient starts spontaneous breathing, with following agents-
              Inj. Neostigmine - 50 mcg/kg IV
              Inj. Glycopyrrolate - 10 mcg/kg IV

During this period patient will be ventilated with 100% oxygen with fresh gas flow of 4- 6 liters/min. Patient will be extubated when regular spontaneous breathing pattern become established and patient is able to open the eyes on command. Patient will now shifted to post anaesthesia care unit (PACU).
l)Monitoring
1.Intubation time: The time from first picking up the laryngoscope until the first
capnography upstroke following intubation.
(considering only successful attempt)

2. No. of attempts of device insertion (maximum 2)
3.Quality of visualization of glottic aperture

Cormack and Lehane grading

•      Grade I: Visualization of entire vocal cords

•      Grade II: Visualization of posterior part of the laryngeal aperture

•      Grade III: Visualization of epiglottis

•      Grade IV: No glottis structure seen

 

CORMACK & LEHANE GRADE

Group A

Group M

grade I

 

 

grade II

 

 

grade III

 

 

grade IV

 

 

       

4. Optimization maneuvers required for intubation like jaw thrust, external laryngeal pressure or using a bougie.

Maneuvers required

               Score

No maneuvers required

N1=0

 

 

External laryngeal pressure /jaw thrust

N2=1

 

 

Use of bougie

N3=2

 

 

Total (N1+N2+N3)

 

 5.Vital parameters: Hemodynamic parameters like heart rate, mean blood pressure, SpO2 and EtCO2 will be noted.

                        

Parameters

(time in minutes)

Baseline

At the time of induction

At the time of intubation

1

2

3

4

5

10

20

30

60

90

120

Post

op

Pulse

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Mean BP

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

SpO2

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

EtCO2

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 






6. Incidence of airway trauma and complications:

                        Traumatic intubation was defined as the presence of any of the following: blood soiling on the tracheal tube on extubation; hoarse cry voice; and sore throat either immediately after extubation or at 24–48 h postoperatively

                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         intraoperative complication

Bronchospasm, Desaturation      

        

Postoperative complication

           
Sore throat, hoarseness of voice, Coughing, Dysphagia

 

 


 
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