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CTRI Number  CTRI/2019/10/021568 [Registered on: 09/10/2019] Trial Registered Prospectively
Last Modified On: 03/10/2019
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparison of Endotracheal intubation between video laryngoscopy(McGrath) and direct laryngoscopy in children. 
Scientific Title of Study   Comparison of McGrath video laryngoscope with conventional Macintosh laryngoscope for tracheal intubation in paediatric patients with normal airway. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Stuti Bhamri 
Designation  PG Student 
Affiliation  SSG Hospital,Vadodara. 
Address  B-2008,Indira nagar,Luckhnow-226016.

Lucknow
UTTAR PRADESH
226016
India 
Phone  8095710767  
Fax    
Email  stutibhamri@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Devyani Desai 
Designation  Associate Professor 
Affiliation  S.S.G. HOSPITAL 
Address  Department Of Anaesthesiology, S.S.G. Hospital, Vadodara

Vadodara
GUJARAT
390001
India 
Phone  9909983168  
Fax    
Email  devyani.dr@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Devyani Desai 
Designation  Associate Professor 
Affiliation  S.S.G. HOSPITAL 
Address  Department Of Anaesthesiology, S.S.G. Hospital, Vadodara

Chitrakoot
GUJARAT
390001
India 
Phone  9909983168  
Fax    
Email  devyani.dr@gmail.com  
 
Source of Monetary or Material Support  
SSG Hospital, Vadodara 
 
Primary Sponsor  
Name  SSG HospitalVadodara 
Address  SSG Hospital,Sayajigunj,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 
DrStuti Bhamri  SSG Hospital  Department of anaesthesiology, New Surgical Block, SSG Hospital, Sayajigunj
Vadodara
GUJARAT 		 8095710767

stutibhamri@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee for Human Research(IECHR)-Post Graduate Research  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K561||Intussusception,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Conventional Macintosh laryngoscope assisted intubation  Comparison of McGrath video laryngoscope with conventional Macintosh laryngoscope for tracheal intubation in paediatric patients with normal airway. 
Intervention  Video Laryngoscope assisted Intubation  Comparison of McGrath video laryngoscope with conventional Macintosh laryngoscope for tracheal intubation in paediatric patients with normal airway. 
 
Inclusion Criteria  
Age From  1.00 Year(s)
Age To  5.00 Year(s)
Gender  Both 
Details  1.Patients posted for elective surgery under general anaesthesia requiring endotracheal intubation.
2.Age: 01 to 05yrs
3.Weight: 10-20kg
4.Gender: Either gender.
5.ASA I & II
6.Mouth opening >20 mm 
 
ExclusionCriteria 
Details  1.Patients with expected difficult airway intubation
2.Patients with congenital anomaly
3.Upper respiratory tract infection
4.Preexisting laryngeal or tracheal pathology
5.Patient’s parents/guardian not willing for participation

 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment    
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Total Interval Time for intubation (in seconds)  Total Interval Time for intubation (in seconds) 
 
Secondary Outcome  
Outcome  TimePoints 
Glottic Exposure time
Number of attempts of devise insertion
Number of attempts of tube insertion
Intubation Difficulty Scale
Vital parameters
Complications 		 Glottic Exposure time 
 
Target Sample Size   Total Sample Size="88"
Sample Size from India="88" 
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)   10/10/2019 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

The study will be a type of prospective randomised controlled trial undertaken in paediatric patients admitted in SSG hospital requiring general anesthesia with endotracheal intubation with a sample size of 88 patients.

Patient will be kept nil by mouth for minimum 6-8 hours before surgery and an intravenous line will be secured. After thorough pre-anaesthetic check up, an informed written consent will be taken from the patient’s parent / guardian. Cylinders, trolley, airway equipment and drugs will be kept ready before induction; multipara monitor will be attached and baseline vital parameters will be noted.

For McGrath video laryngoscope, paediatric non-channeled blade (size no. 2) will be mounted on the handle containing battery. The performance of the device will be checked by watching the clarity of the image on monitor.

For McIntosh laryngoscope, appropriate sized paediatric blade (size no. 2) will be mounted on the handle. The performance of the device will be checked by adequate intensity of the light.

Appropriate size of ET tube with stylet will be kept ready.

As premedication, Inj. Glycoprrolate 5mcg/kg iv and Inj. Tramadol 2mg/kg iv 5 minutes prior to induction.

            Induction will be done with increasing concentrations of sevoflurane starting from 1% with 100% O2 with 6 litres/min flow using Jackson-Rees circuit. The sevoflurane concentration will be increased by 1% every 2 to 3 breaths. After achieving loss of eyelash reflex, IV Inj Atracurium 0.3-0.5 mg/kg will be given. Ventilation will be controlled by positive pressure mask ventilation after achieving apnoea by the patients on their own and will be made as uniform as possible with the help of capnography (35-45 cm H2O). All the intubation procedures will be done by me. Intubation will be done as follows - 

 

Method of Endotracheal intubation:

❑      Group G (with McGrath Video laryngoscopy)

•       Patient’s head will be kept in neutral position.

•       The McGrath blade of pediatric size (size 2) will be mounted on the McGrath video laryngoscope and introduced from the center of the mouth towards the glottis by viewing on the screen of the monitor so that it will barely lift the epiglottis with the tip of the blade.

•       After obtaining optimal laryngeal view, the appropriate size uncuffed, PVC endotracheal tube with stylet will be advanced by the side of the scope viewing on the screen of the monitor.

 

❑        Group M (with Macintosh)

•       Patient’s head will be kept in sniffing position.

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

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

Time to Glottic exposure (TTG), Cormack and Lehane grading of laryngeal view, Time to Intubation (TTI), optimization maneuvers like external laryngeal pressure or increasing scope lifting force and intubation difficulty scale will be recorded.

In case of first trial failure, a second trial will be performed after mask ventilation. Maximum 2 attempts with the selected laryngoscope will be allowed. In case of second trial failure, an alternative device (i.e. Macintosh laryngoscope in case of failure with McGrath video laryngoscope and vice versa) will be used for intubation after mask ventilation.

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. 

Maintenance :

         After intubation, Jackson-Rees circuit will be attached to the endotracheal tube and bilateral air entry will be confirmed by chest auscultation as well as by capnography and anaesthesia will be maintained with Oâ‚‚+Nâ‚‚O (50:50%) with sevoflurane and intermittent Inj Atracurium 0.02 mg/kg.

Reversal:

At the end of surgery, N2O and anesthetic agent will be stopped before 10 mins and patient will be ventilated with 100% oxygen. Reversal will be done once patient starts spontaneous breathing with IV  Inj. Neostigmine 50 mcg/kg and Inj. Glycopyrrolate 10 mcg/kg.

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 then be shifted to post anaesthesia care unit (PACU).

 

 
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