| 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
|
|
|
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
|
|
|
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. |