| CTRI Number |
CTRI/2025/09/094230 [Registered on: 04/09/2025] Trial Registered Prospectively |
| Last Modified On: |
27/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of different airway devices ( LMA Supreme VERSUS I-Gel ) in planned short duration surgeries under general anaesthesia in children. |
|
Scientific Title of Study
|
A comparison of I-Gel versus laryngeal mask airway(LMA) supreme for elective short surgical procedures under general anaesthesia with spontaneous ventilation in paediatric patients. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Armaandeep Singh |
| Designation |
Ist Year PG Anaesthesiology |
| Affiliation |
Adesh Institute of Medical Sciences and Research |
| Address |
Room no.214 Second floor Department of Anaesthesiology & Intensive care Adesh Institute of Medical Sciences and Research Bathinda Punjab 151001 India
Bathinda
PUNJAB
151001
India |
| Phone |
7695003469 |
| Fax |
|
| Email |
armaanpoplabana@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shilpa Bansal |
| Designation |
Professor ,Department of Anaesthesiology and Intensive Care ,AIMSR Bathinda |
| Affiliation |
Adesh Institute of Medical Sciences and Research Bathinda Punjab |
| Address |
Room no.214 Second floor Department of Anaesthesiology & Intensive care Adesh Institute of Medical Sciences and Research Bathinda Punjab 151001 India
Bathinda
PUNJAB
151001
India |
| Phone |
9915433522 |
| Fax |
|
| Email |
bansalshilpa304@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shilpa Bansal |
| Designation |
Professor ,Department of Anaesthesiology and Intensive Care ,AIMSR Bathinda |
| Affiliation |
Adesh Institute of Medical Sciences and Research Bathinda Punjab |
| Address |
Room no.214 Second floor Department of Anaesthesiology & Intensive care Adesh Institute of Medical Sciences and Research Bathinda Punjab 151001 India
Bathinda
PUNJAB
151001
India |
| Phone |
9915433522 |
| Fax |
|
| Email |
bansalshilpa304@gmail.com |
|
|
Source of Monetary or Material Support
|
| Adesh Institute of Medical Sciences and Research Bathinda Punjab 151001 India |
|
|
Primary Sponsor
|
| Name |
Adesh Institute of Medical Sciences and Research Bathinda |
| Address |
Adesh Institute of Medical Sciences and Research Bathinda Punjab 151001 India |
| Type of Sponsor |
Private medical college |
|
|
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 |
| DrArmaandeep Singh |
Adesh Institute of Medical Sciences and Research Bathinda Punjab 151001 India |
Department of Anaesthesiology & Intensive care Adesh Institute of Medical Sciences and Research Bathinda Punjab 151001 India
Bathinda
PUNJAB |
7695003469
armaanpoplabana@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee Adesh University |
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 |
I-GEL And LMA SUPREME |
I GEL-It has non-inflatable cuff that provides a reliable seal, reducing the risk of airway
trauma compared to traditional endotracheal intubation. It is available in various sizes,
making it suitable for both adult and pediatric patients. Its allows easy insertion and effective
ventilation with fewer complications, such as sore throat or laryngospasm, and promotes
smoother recovery for patients undergoing short surgical procedures.
LMA SUPREME- - It has inflatable cuff for a tight seal at the larynx, reducing the risk of air
leakage. It offers easy insertion, good ventilation, minimal trauma to airway structures, faster
recovery and lower rates of sore throat or laryngospasm, making it a reliable choice for
pediatric anesthesia. |
| Intervention |
IGEL, LMA SUPREME |
Preoxygenation with 100% oxygen for 3 minutes via mask will be done.
Induction – Intravenous induction of anaesthesia with Inj ketamine 2mg/kg and
simultaneous mask ventilation with 100% O2 and 2-3% sevoflurane 6L/min flow rate
via Jackson Rees circuit will be done.
Either I-GEL or LMA supreme will be inserted by an experienced anesthesiologist
with more tha 5 years of experience. |
|
|
Inclusion Criteria
|
| Age From |
6.00 Month(s) |
| Age To |
6.00 Year(s) |
| Gender |
Both |
| Details |
All genders
ASA Grading I,II
Patient undergoing elective short surgeries for duration for 60-90 minutes under general anaesthesia |
|
| ExclusionCriteria |
| Details |
Non consenting parents
Difficult airway ( MPC CLASS 3 or more)
Presence of any disease or surgery of neck,upper respiratory tract and upper gastrointestinal tract
Congenital airway abnormalities. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the efficacy and safety of I-GEL versus LMA SUPREME for elective short surgical proceduresunder general anaesthesia with spontaneous ventilation in paediatric patients in terms of insertion time ,ease of insertion andnumber of attempts |
To compare the efficacy and safety of I-GEL versus LMA SUPREME for elective short surgical proceduresunder general anaesthesia with spontaneous ventilation in paediatric patients in terms of insertion time ,ease of insertion ,number of attempts and hemodynamics at different time intervals like baseline , at induction , after induction ,every 5 minutes after insertion of Supragottic airway device till 15 minutes . |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare ease of insertion of gastric catheter. |
An appropriate sized lubricated suction catheter will be passed through the gastric channel of device to prevent gastric insulation and ease of insertion will be recorded |
| To assess hemodynamic parameters. |
Variation between the heart rate ,blood pressure respiratory rate ,spo2,and ETCO2 will be recorded before induction , after induction just after SGA insertion then after 5,10,15 minutes after insertion of device . |
| To compare perioperative complications. |
Any complications during insertion of SGA like coughing, gagging ,regurgitation ,vomiting ,patients movement and trauma will be noted. |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
15/09/2025 |
| 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
|
Airway management is fundamental component of successful anaesthesia practice. endotracheal intubation is th gold standard for securing airwy in anaesthetized patient . Inroduction of supraglottic airway devices (SGAs) represented a signifant advancement in airway management developed by Dr Archie Brain in 1988. It eliminated the requirement of laryngoscopy and reduced the dependance on muscle relaxants. In paediatric patients , supraglottic airway (SGA) devices are commonly used for a variety of short and minimally invasive surgeries. They have easier and faster placement , less airway trauma, reduced hemodynamic response, and smoother recovery . while they offer disadvantages like they do not protect the airway as effectively as endotracheal tubes . I-GEL has non inflatable cuff that provides a reliable seal , reducing the risl of airway trauma compared to traditional endotracheal intubation LMA SUPREME has inflatable cuff fo a tiht seal at larynx , reducing the risk of air leakage . the I-GEL and LMA SUPREME are widely used , but mostly in adults with limited reserch comparing their effectiveness in paediatric patients who represent unique anatomical and physiological challenges . this study aims to bridge the gap in paediatric SGA research by comparing both devices in terms of ease of insertion , time required for insertion , airway stability and perioperative complications. these findings will provide valueable insights for optimizing airway management strategies in paediatric patients undergoing short elective surgeries. |