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CTRI Number  CTRI/2025/10/095761 [Registered on: 09/10/2025] Trial Registered Prospectively
Last Modified On: 08/10/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Prospective Observational Study 
Study Design  Other 
Public Title of Study   This study looks at how well doctor can see windpipe of child less then one year using a camera and how that affects time taken to insert breathing tube 
Scientific Title of Study   Video laryngoscopy guided glottic view grading and its correlation with tracheal intubation time in infants undergoing surgery. A prospective observational study  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Rakesh Kumar 
Designation  Addtional Professor 
Affiliation  All India Institute of Medical Sciences, Jodhpur 
Address  Department of Anaesthesiology and Critical care All India Institute Of Medical Sciences(AIIMS) Basni Industrial Area Phase-2 Jodhpur

Jodhpur
RAJASTHAN
342005
India 
Phone  946042922  
Fax    
Email  drrakeshspmc@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Rakesh Kumar 
Designation  Additional Professor 
Affiliation  All India Institute of Medical Sciences, Jodhpur 
Address  Department of Anaesthesiology and Critical care All India Institute Of Medical Sciences(AIIMS) Basni Industrial Area Phase-2 Jodhpur

Jodhpur
RAJASTHAN
342005
India 
Phone  9460429221  
Fax    
Email  drrakeshspmc@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Manju S H  
Designation  Junior Resident  
Affiliation  All India Institute of Medical Sciences, Jodhpur 
Address  Department of Anaesthesiology and Critical care All India Institute Of Medical Sciences(AIIMS) Basni Industrial Area Phase-2 Jodhpur

Jodhpur
RAJASTHAN
342005
India 
Phone  9916326747  
Fax    
Email  manjushmshmsh1999@gmail.com  
 
Source of Monetary or Material Support  
All India Institute of Medical Sciences Jodhpur Marudhar Industrial Area, 2nd Phase, M.I.A. 1st Phase, Basni, Basni, Jodhpur, Rajasthan, India. Pincode-342005  
 
Primary Sponsor  
Name  All India Institute of Medical Sciences Jodhpur 
Address  Marudhar Industrial Area,Basni Phase 2,Jodhpur,342005 
Type of Sponsor  Research institution and hospital 
 
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 Manju S H   All India Institute of Medical Sciences, Jodhpur  Department of Anaesthesiology and Critical Care Jodhpur
Jodhpur
RAJASTHAN 		 9916326747

manjushmshmsh1999@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee , All Institute of Medical Sciences , Jodhpur  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Children less than 1 year undergoing surgery  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  0.00 Month(s)
Age To  12.00 Month(s)
Gender  Both 
Details  Infants aged 0 to 12 months undergoing elective or emergency surgery requiring
endotracheal intubation under general anaesthesia.
American Society of Anaesthesiologists status I to IV.
Infants with anticipated normal airway anatomy.
Written informed consent from parents or guardians. 
 
ExclusionCriteria 
Details  Infants with known or suspected difficult airway eg craniofacial anomalies ,
airway malformations, micrognathia.
Presence of upper airway pathologies such as tumors, trauma, or infections.
Previous neck or airway surgeries.
Infants with hemodynamic instability or severe cardiopulmonary compromise.
Refusal of parental or guardian consent. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
The incidence of Video laryngoscopy-guided glottic view grading(easy & restricted)

 		 Till endotracheal intubation

 
 
Secondary Outcome  
Outcome  TimePoints 
Cormack & Lehane grading.
First-attempt success rate which is defined as successful laryngoscopy & intubation
on the first try.
POGO Score.
Number of laryngoscopy & intubation attempts.
Incidence of multiple intubation attempts.
Time to optimal glottic view (from device insertion to best view).
Time to successful tracheal intubation (from device insertion to tube placement).
Use of a bougie/ additional maneuvers (BURP).
Occurrence of airway-related complications.
Lowest recorded oxygen saturation during airway management. 		 Till successful endotracheal intubation 
 
Target Sample Size   Total Sample Size="87"
Sample Size from India="87" 
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)   17/11/2025 
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 Yet Recruiting 
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   Airway management in infants is one of the most critical and technically challenging
aspects of pediatric anesthesia. Infants present unique anatomical and physiological
characteristics that can complicate tracheal intubation, including a larger tongue, a
more cephalad and anterior larynx, and a narrower airway lumen. These factors
contribute to a higher risk of failed or prolonged intubation, with potential for
significant morbidity such as hypoxemia, bradycardia, and airway trauma. Therefore,
optimizing the visualization of the glottis and understanding its relationship with
intubation outcomes is essential for improving the safety and efficacy of airway
management in this vulnerable population.
Video laryngoscopy (VL) has gained widespread acceptance in pediatric anesthesia
and critical care settings due to its ability to provide enhanced visualization of the
glottis compared to traditional direct laryngoscopy (DL). Unlike DL, which relies
on a direct line of sight, VL offers an indirect view of the airway structures via a
camera at the tip of the laryngoscope blade. This improved view can lead to better
glottic visualization, potentially increasing the success rate of tracheal intubation and
decreasing the time required to secure the airway.[7] Despite these advantages, the predictive value of videolaryngoscopic glottic view grading on intubation outcomes,
particularly in infants, remains underexplored.
Several grading systems, such as the Cormack-Lehane (CL) classification, are
commonly used to describe glottic views during laryngoscopy. However, these
systems were originally developed for adults and direct laryngoscopy, which may
limit their applicability in infants or with videolaryngoscopy. Recently, a specific six-
stage glottic view grading for videolaryngoscopy has been proposed to better capture
the nuances of VL-based airway assessments.  Despite this progress, there is a
paucity of prospective data examining the relationship between glottic view grading
and actual intubation performance, including time to successful tube placement, in
the infant population.
This prospective observational study aims to evaluate the correlation between video
laryngoscopy-guided glottic view grading and tracheal intubation time in infants
undergoing elective surgery. By systematically recording and analyzing
videolaryngoscopic views and timing data, we aim to determine whether glottic view
grading can serve as a reliable predictor of intubation difficulty and duration
 
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