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CTRI Number  CTRI/2025/11/098178 [Registered on: 28/11/2025] Trial Registered Prospectively
Last Modified On: 27/11/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Medical Device
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   A study comparing camera guided and regular methods of placing a breathing device inside mouth in children before surgery 
Scientific Title of Study   Comparison Of Clinical Performance of Video Laryngoscope Guided Vs Blind Placement of I Gel in Paediatric Patients A Randomised Controlled Open Label Trial 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  RAKHI V P 
Designation  Junior Resident 
Affiliation  Armed Forces Medical College 
Address  Dept of Anaesthesiology and Critical Care Armed forces medical college Wanowarie Pune- 411040

Pune
MAHARASHTRA
411040
India 
Phone  8825893608  
Fax    
Email  rakhivp007@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  GUNJAN SINGH 
Designation  PROFESSOR 
Affiliation  AFMC 
Address  Dept of Anaesthesiology and Critical Care AFMC
Wanowarie Pune- 411040
Pune
MAHARASHTRA
411040
India 
Phone  9612112136  
Fax    
Email  gunjanafmc@gmail.com  
 
Details of Contact Person
Public Query
 
Name  GUNJAN SINGH 
Designation  PROFESSOR 
Affiliation  AFMC 
Address  Dept of Anaesthesiology and Critical Care AFMC
Wanowarie Pune- 411040
Pune
MAHARASHTRA
411040
India 
Phone  9612112136  
Fax    
Email  gunjanafmc@gmail.com  
 
Source of Monetary or Material Support  
Dept of anaesthesiology and critical care Armed forces medical college Wanowarie Pune- 411040 
 
Primary Sponsor  
Name  RAKHI V P 
Address  Dept of Anaesthesiology and Critical Care Armed forces medical college Wanowarie Pune- 411040 
Type of Sponsor  Other [self] 
 
Details of Secondary Sponsor  
Name  Address 
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 GUNJAN SINGH  Armed forces medical college  1st floor Dept of Anaesthesiology and Critical Care Armed forces medical college Wanowarie Pune 411040
Pune
MAHARASHTRA 
09612112136

gunjanafmc@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IECAFMCPUNE  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  insertion of Igel blind insertion technique in paediatric patients  incidence of malpositioning of Igel by blind insertion technique in paediatric patients 
Intervention  insertion of Igel video laryngoscope guided in paediatric patients  incidence of malpositioning of I gel using video laryngoscope guided technique in paediatric patients 
 
Inclusion Criteria  
Age From  2.00 Year(s)
Age To  6.00 Year(s)
Gender  Both 
Details  All paediatric patients 2 to 6 yrs
Scheduled for elective infraumbilical surgery in supine position Under general anaesthesia
ASA physical status I or II
 
 
ExclusionCriteria 
Details  Emergency surgeries non elective procedures
Anticipated difficult airway
Having history of URTI
gastroesophageal reflux
Mass in the pharyngeal laryngeal cavity
syndromic babies
Insertion attempt more than 3
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To compare clinical performance of video laryngoscope vs blind placement of I-gel in paediatric patients  base line time only after insertion will check position of i gel 
 
Secondary Outcome  
Outcome  TimePoints 
To compare the hemodynamic parameters & the insertion characteristics such as the number of attempts, ease of insertion & time required for successful insertion between two insertion technique  baseline time only after insertion  
 
Target Sample Size   Total Sample Size="46"
Sample Size from India="46" 
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 3/ Phase 4 
Date of First Enrollment (India)   10/12/2025 
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  

Second generation supraglottic airway devices have made airway management safer in children during surgery under general anaesthesia. The i gel is one of the most commonly used devices because it is easy to insert, usually requires fewer attempts, and provides a good seal that allows normal and assisted breathing. Traditionally, doctors insert the i gel without directly seeing the airway, known as blind insertion. However, studies using fibreoptic scopes have shown that even when the breathing looks fine, the device may not always be positioned correctly.

Previous research has compared the blind method with using a video laryngoscope, which is a camera that lets the doctor see the airway while inserting the device. Kumar and colleagues found that using the camera resulted in much fewer malpositions compared to the blind method and also gave better airway seal and visibility, though both methods were similarly successful in overall placement. Another study by Behera and colleagues, which used a different airway device called the Ambu AuraGain, did not find the same benefit, suggesting that results may vary depending on the device type.

Other studies have confirmed that the i gel performs well compared with other airway devices in children, offering faster placement and good ventilation. Imaging studies have also shown that blind insertion can lead to malposition in many children, even when breathing seems adequate. Overall, using video guidance to insert the i gel appears to improve how well the device fits, although more studies are needed in different age groups and situations.

 
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