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CTRI Number  CTRI/2025/09/095368 [Registered on: 24/09/2025] Trial Registered Prospectively
Last Modified On: 23/09/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparing two breathing tube shapes to see which is easier to insert in babies less than one year 
Scientific Title of Study   Comparison of C-shaped with Hockey stick shaped stylet for endotracheal intubation in neonates and infants using miller blade videolaryngoscope 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Subash R 
Designation  Post Graduate Resident 
Affiliation  Vardhman Mahavir medical college and Safdarjung hospital 
Address  Department of Anaesthesia and Intensive care, Vardhman Mahavir medical college and Safdarjung hospital, Ansari nagar East, New Delhi

New Delhi
DELHI
110029
India 
Phone  9486823787  
Fax    
Email  subashramasamy1998@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Vanya Chugh 
Designation  Professor and Consultant 
Affiliation  Vardhman Mahavir medical college and Safdarjung hospital 
Address  Department of Anaesthesia and Intensive care, Vardhman Mahavir medical college and Safdarjung hospital, Ansari nagar East, New Delhi

New Delhi
DELHI
110029
India 
Phone  9999977026  
Fax    
Email  vanya_chugh@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  Dr Vanya Chugh 
Designation  Professor and Consultant 
Affiliation  Vardhman Mahavir medical college and Safdarjung hospital 
Address  Department of Anaesthesia and Intensive care, Vardhman Mahavir medical college and Safdarjung hospital, Ansari nagar East, New Delhi

New Delhi
DELHI
110029
India 
Phone  9999977026  
Fax    
Email  vanya_chugh@yahoo.co.in  
 
Source of Monetary or Material Support  
Department of Anaesthesia and Intensive care, Vardhman Mahavir medical college and Safdarjung hospital, Ansari nagar East, New Delhi 
 
Primary Sponsor  
Name  Vardhman Mahavir medical college and Safdarjung hospital 
Address  Department of Anaesthesia and Intensive care, Vardhman Mahavir medical college and Safdarjung hospital, Ansari nagar East, 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 Subash R  Vardhman Mahavir medical college and Safdarjung hospital  Department of Anaesthesia and Intensive care, Ansari nagar East, New Delhi
New Delhi
DELHI 		 9486823787

subashramasamy1998@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Vardhman Mahavir medical college and Safdarjung hospital Institutional Ethics Committee   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 
Intervention  C-shaped stylet  After group allocation, .Induction of general anaesthesia will be carried out as per Institutional protocol. Meanwhile, endotracheal tube will be prepared into C shape. Shape will be defined as per a pre formed template. Thereafter, the operator will perform a videolaryngoscopy using C-MAC videolaryngoscope with an appropriate size Miller blade. After obtaining the best glottic view, the endotracheal tube will be inserted. All the parameters will be recorded. ETT placement will be confirmed by five point auscultation and appearance square wave capnography. 
Comparator Agent  Hockey stick shaped stylet  After group allocation, .Induction of general anaesthesia will be carried out as per Institutional protocol. Meanwhile, endotracheal tube will be prepared into hockey Stick shape. Shape will be defined as per a pre formed template. Thereafter, the operator will perform a videolaryngoscopy using C-MAC videolaryngoscope with an appropriate size Miller blade. After obtaining the best glottic view, the endotracheal tube will be inserted. All the parameters will be recorded. ETT placement will be confirmed by five point auscultation and appearance square wave capnography. 
 
Inclusion Criteria  
Age From  1.00 Day(s)
Age To  12.00 Month(s)
Gender  Both 
Details  Children less than 12 months of age for surgery under general anaesthesia requiring endotracheal intubation
Patients those who are classified as Grade 1 and 2 according to American Society of Anaesthesiologists Physical Status. 
 
ExclusionCriteria 
Details  Patients with anticipated difficult airway Patients with upper respiratory tract infections 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To compare C-shaped with Hockey stick shaped stylet for endotracheal intubation in neonates and infants using C-MAC Miller videolaryngoscope in terms of ETT Placement time, the time from obtaining the best glottic view till the passage of endotracheal tube into the glottis up to the desired depth.  It is assessed intraoperatively after induction of general Anaesthesia during attempt at endotracheal intubation  
 
Secondary Outcome  
Outcome  TimePoints 
Time to glottic visualization using Miller blade Videolaryngoscope
Incidence of successful intubation in first attempt in less than 30 seconds
Number of intubation attempts 		 It is assessed intraoperatively after induction of general Anaesthesia during attempt at endotracheal intubation  
 
Target Sample Size   Total Sample Size="130"
Sample Size from India="130" 
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   Phase 4 
Date of First Enrollment (India)   05/10/2025 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   Endotracheal intubation is a pivotal step in securing the airway in paediatric patients. Anatomical and physiological differences render the paediatric airway more challenging compared to adult population. These differences are more pronounced in neonatal age group and infancy. Owing to high oxygen consumption and small functional residual capacity, they are more susceptible to hypoxemia.
Though videolaryngoscopy offers a remarkable glottic view, negotiating the endotracheal tube through the glottis can be arduous. The ETT may repeatedly strike the posterior part of glottis or abut against the anterior tracheal wall causing difficulty in advancing it into the trachea. Optimizing the shape of ETT using a stylet has been shown to improve the success rate of intubation with videolaryngoscopy. Various shapes of the stylet have been utilized for intubation with a videolaryngoscope. Though studies in adult patients suggest the use of hockey stick shaped configuration as the preferable shape, there is a paucity of literature regarding the appropriate stylet shape when used for neonates and infants during videolaryngoscopy.12 Hence, we planned this study comparing C-shaped versus Hockey stick shaped stylet for endotracheal intubation in neonates and infants using Miller blade videolaryngoscope.
 
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