| CTRI Number |
CTRI/2025/09/094315 [Registered on: 08/09/2025] Trial Registered Prospectively |
| Last Modified On: |
05/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To compare the efficacy of 2 single use airway devices with a reusable airway device to see how well they support breathing in children during surgery under general anaesthesia. |
|
Scientific Title of Study
|
Comparison of efficacy of two single use supraglottic devices with a reusable supraglottic device for ventilation in paediatric patients undergoing elective surgery under general anaesthesia |
| 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 Faiez Farhan K M |
| Designation |
PG Resident |
| Affiliation |
VMMC and Safdarjung Hospital |
| Address |
Department of Anesthesia and Intensive Care, ground floor, main
operation theatre building, Safdarjung Hospital Campus, Ansari
Nagar East, New Delhi
New Delhi
DELHI
110029
India |
| Phone |
9562329264 |
| Fax |
|
| Email |
farhan.faiez@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nidhi Agrawal |
| Designation |
Professor |
| Affiliation |
VMMC and Safdarjung Hospital |
| Address |
Department of Anesthesia and Intensive Care, ground floor, main
operation theatre building, Safdarjung Hospital Campus, Ansari
Nagar East, New Delhi
New Delhi
DELHI
110029
India |
| Phone |
9811030408 |
| Fax |
|
| Email |
nidhi.agrawal1970@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nidhi Agrawal |
| Designation |
Professor |
| Affiliation |
VMMC and Safdarjung Hospital |
| Address |
Department of Anesthesia and Intensive Care, ground floor, main
operation theatre building, Safdarjung Hospital Campus, Ansari
Nagar East, New Delhi
New Delhi
DELHI
110029
India |
| Phone |
9811030408 |
| Fax |
|
| Email |
nidhi.agrawal1970@gmail.com |
|
|
Source of Monetary or Material Support
|
| VMMC and Safdarjung Hospital |
|
|
Primary Sponsor
|
| Name |
VMMC and Safdarjung Hospital |
| Address |
VMMC and Safdarjung Hospital, Ansari Nagar East, New Delhi, 110029 |
| Type of Sponsor |
Government 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 |
| Dr Faiez Farhan K M |
VMMC and Safdarjung Hospital |
Department of anaesthesiology and intensive care, VMMC and Safdarjung hospital, Ansari Nagar East, New Delhi, 110029
South West
DELHI |
9562329264
farhan.faiez@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| VMMC AND SAFDARJUNG HOSPITAL INSTITUTIONAL ETHICS COMMITTEE |
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 |
| Intervention |
BlockBuster LMA |
BlockBuster Laryngeal Mask Airway (LMA) of appropriate size, as per manufacturer’s recommendation, will be inserted in paediatric patients undergoing elective surgery under general anaesthesia. Oropharyngeal seal pressure and insertion characteristics will be assessed. |
| Intervention |
I-Gel |
I-Gel supraglottic airway device of appropriate size, as per manufacturer’s recommendation, will be inserted in paediatric patients undergoing elective surgery under general anaesthesia. Oropharyngeal seal pressure and insertion characteristics will be assessed. |
| Comparator Agent |
ProSeal LMA |
ProSeal Laryngeal Mask Airway (LMA) of appropriate size, as per manufacturer’s recommendation, will be inserted in paediatric patients undergoing elective surgery under general anaesthesia. Oropharyngeal seal pressure and insertion characteristics will be assessed. |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
10.00 Year(s) |
| Gender |
Both |
| Details |
This study will be conducted in children weighing 10 - 30 kg, fulfilling the criteria of American Society of Anaesthesiologists (ASA) Physical Status 1 and 2, undergoing elective surgery under general anaesthesia with controlled ventilation. |
|
| ExclusionCriteria |
| Details |
1. Patients with an anticipated difficult airway.
2. Patient with high risk of aspiration. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Oropharyngeal seal pressure of the device will be measured. |
Oropharyngeal seal pressure of the device will be measured at 5 minutes and 30 minutes after insertion of device. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Number of attempts taken for successful insertion of the device. |
This will be noted after the successful insertion of the device. |
| Time taken for achieving effective ventilation. |
It will be noted from, holding the supraglottic device at the teeth for insertion, to obtaining the first square wave capnograph tracing, confirming effective ventilation. |
| Anatomical alignment of the device to glottic opening by Brimacombe score. |
It will be measured after the insertion of the device. |
| The ease of insertion of the device and the gastric catheter will be noted. |
It will be noted after insertion of the device and the gastric catheter. |
|
|
Target Sample Size
|
Total Sample Size="156"
Sample Size from India="156"
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)
|
16/09/2025 |
| 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 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
|
The efficacy of LMA ProSeal and Igel is compared with that of Blockbuster LMA for ventilation in children undergoing elective surgery under general anaesthesia by assessing oropharyngeal leak pressure. The primary outcome measured will be the oropharyngeal seal pressure measured at 5 minutes and 30 minutes after insertion of the device. Other secondary outcomes include the number of attempts taken for successful insertion of the device, time taken for effective ventilation, ease of insertion of device and gastric catheter and anatomical alignment of the device to glottic opening by Brimacombe score. The study will be done in children weighing 10 to 30 kilograms fulfilling the criteria of ASA 1 and 2 under elective surgery under general anaesthesia. The Sample size of the study is 156, that is 52 for each device. |