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CTRI Number  CTRI/2012/09/003011 [Registered on: 24/09/2012] Trial Registered Retrospectively
Last Modified On: 17/06/2014
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   Comparison of use of three different laryngoscopes in children 
Scientific Title of Study   A randomised trial to compare Truview PCD, C-MAC and Macintosh laryngoscopes in paediatric airway management 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
IEC-89 dated 6.2.12  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Nishant Kumar 
Designation  Assistant Professor 
Affiliation  Lady Hardinge Medical College and Assoc. Hospitals 
Address  Shaheed Bhagat Singh Marg, New Delhi

Central
DELHI
110001
India 
Phone    
Fax    
Email  kumarnishant@yahoo.co.uk  
 
Details of Contact Person
Scientific Query
 
Name  Dr Nishant Kumar 
Designation  Assistant Professor 
Affiliation  Lady Hardinge Medical College and Assoc. Hospitals 
Address  Shaheed Bhagat Singh Marg, New Delhi

Central
DELHI
110001
India 
Phone    
Fax    
Email  kumarnishant@yahoo.co.uk  
 
Details of Contact Person
Public Query
 
Name  Dr Nishant Kumar 
Designation  Assistant Professor 
Affiliation  Lady Hardinge Medical College and Assoc. Hospitals 
Address  Shaheed Bhagat Singh Marg, New Delhi

Central
DELHI
110001
India 
Phone    
Fax    
Email  kumarnishant@yahoo.co.uk  
 
Source of Monetary or Material Support  
The Truview Picture Capture Device (PCD) will be provided by Truphatek, Mumbai, India for the purpose of the study. The C-MAC paediatric blade will be provided by Karl Storz Endoscopy, New Delhi, India for the purpose of this study.  
 
Primary Sponsor  
Name  Lady Hardinge Medical College and ASSOC HOSPITALS 
Address  Shaheed Bhagat Singh Marg New Delhi 
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 Nishant Kumar  Main operating theatres  SSKH & KSCH, Shaheed Bhagat Singh Marg
Central
DELHI 
9811934659

kumarnishant@yahoo.co.uk 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Lady Hardinge Medical College & Associated Hospitals  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Paeditric patients posted for elective surgery requiring general anaesthesia with endotracheal intubation,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  C MAC laryngsocope  It is a new videolaryngoscope which gives an indirect view of the vocal cords and previous literature has shown it to be better than the standard macintosh laryngoscope. 
Comparator Agent  Macintosh laryngoscope  It is the standard laryngoscope used for laryngoscopy and endotracheal intubation in all age groups 
Intervention  Truview PCD Laryngoscope  It is a new videolaryngoscope which gives an indirect view of the vocal cords and previous literature has shown it to be better than the standard macintosh laryngoscope. 
 
Inclusion Criteria  
Age From  1.00 Year(s)
Age To  6.00 Year(s)
Gender  Both 
Details  1-6 yrs
either sex
elective surgery
requiring general anaesthesia with endotracheal intubation 
 
ExclusionCriteria 
Details  ASA physical grade 2,
presence of raised intracranial pressure,
high risk for pulmonary aspiration of gastric contents,
coagulopathy
presence of any pathology of head and neck  
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Best laryngeal view obtained (POGO score)  At the time of laryngoscopy 
 
Secondary Outcome  
Outcome  TimePoints 
Time taken to intubate
No. of attempts at intubation
No. of failed intubations
No. of episodes of desaturation
Trauma caused
Need for external laryngeal maneuver 
During intubation and after that 
 
Target Sample Size   Total Sample Size="150"
Sample Size from India="150" 
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/03/2012 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

Prediction of difficult airway is not always possible in a child as measurement of mentohyoid, thyromental, mandibular and inter-incisor lengths have no value. A plethora of airway devices have thus flooded the market to overcome the inadequacy of difficult airway prediction. The videolaryngoscopes have provided a better view of the glottis than the conventional laryngoscopes in adults, however there is limited knowledge of their performance in paediatric patients. We have therefore designed this study to evaluate and compare the Truview PCD and C-MAC laryngoscopes to the standard Macintosh laryngoscope in paediatric patients.

 
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