| CTRI Number |
CTRI/2024/06/068284 [Registered on: 04/06/2024] Trial Registered Prospectively |
| Last Modified On: |
12/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Medical device anaesthesia ] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To compare efficacy of BlockBuster Laryngeal Mask Airway with that of AmbuAuraGain for ventilation in paediatric patients undergoing elective surgery under general anaesthesia |
|
Scientific Title of Study
|
Comparison of efficacy of two anatomically preformed supraglottic devices 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 |
Vignesh Arumugasamy |
| Designation |
Post Graduate Resident |
| Affiliation |
Vardhaman Mahavir Medical College And Safdarjung Hospital, New Delhi |
| Address |
Department of Anaesthesia and Intensive Care, Vardhaman Mahavir Medical College And Safdarjung Hospital, New Delhi
New Delhi
DELHI
110029
India |
| Phone |
9566734748 |
| Fax |
|
| Email |
vignesharumugasamy@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nidhi Agrawal |
| Designation |
Professor, Department of Anaesthesia and Intensive Care |
| Affiliation |
Vardaman Mahavir Medical College And Safdarjung Hospital, New Delhi |
| Address |
Department of Anaesthesia and Intensive Care, Vardaman Mahavir Medical College And Safdarjung Hospital, 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, Department of Anaesthesia and Intensive Care |
| Affiliation |
Vardaman Mahavir Medical College And Safdarjung Hospital, New Delhi |
| Address |
Department of Anaesthesia and Intensive Care, Vardaman Mahavir Medical College And Safdarjung Hospital, New Delhi
New Delhi
DELHI
110029
India |
| Phone |
9811030408 |
| Fax |
|
| Email |
nidhi.agrawal1970@gmail.com |
|
|
Source of Monetary or Material Support
|
| Vardaman Mahavir Medical College And Safdarjung Hospital, New Delhi; India; 110029
|
|
|
Primary Sponsor
|
| Name |
Vardaman Mahavir Medical |
| Address |
Vardaman Mahavir Medical College And Safdarjung Hospital, New Delhi
|
| 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 Vignesh Arumugasamy |
Vardhman Mahavir Medical College and Safdarjung Hospital |
Department of Anaesthesia And Intensive Care, Ground Floor, Main OT Block, Vardhman Mahavir Medical College and Safdarjung Hospital,
New Delhi
New Delhi
DELHI |
9566734748
vignesharumugasamy@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Government of India, Ministry of health and Family Welfare, Vardhman Mahavir Medical College and Safdarjung hospital, New Delhi, 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 |
AmbuAuraGain |
Oropharyngeal seal pressure will be noted within 5 minutes after device insertion and the next reading will be taken after 30 minutes of device insertion. |
| Comparator Agent |
Block Buster Laryngeal mask airway |
Oropharyngeal seal pressure will be noted within 5 minutes after device insertion and the next reading will be taken after 30 minutes of device insertion. |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
10.00 Year(s) |
| Gender |
Both |
| Details |
American Society of Anaesthesiologist Physical Status I and II and undergoing elective surgical procedures under general anaesthesia with controlled ventilation |
|
| ExclusionCriteria |
| Details |
1. Patients with anticipated difficult airway
2. Anticipated surgery time greater than 4 years
3. High risk of aspiration |
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare oropharyngeal seal pressure of BlockBuster Laryngeal Mask airway with that of AmbuAuraGain in paediatric patients undergoing elective surgery under general anaesthesia |
Oropharyngeal seal pressure will be noted within 5 minutes after device insertion and the next reading will be taken after 30 minutes of device insertion. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare following insertion characteristics of BlockBuster Laryngeal mask airway with that of Ambu AuraGain |
Number of attempts taken for successful insertion of the device.
Time taken for achieving effective ventilation .
Ease of insertion of device & gastric catheter.
Anatomical alignment of the device to glottis opening by Brimacombe score.
These parameters will be measured within a duration of half an hour. |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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
Modification(s)
|
Phase 1/ Phase 2 |
|
Date of First Enrollment (India)
|
12/06/2024 |
| 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
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The supraglottic airway devices(SADs) are commonly used for airway management during anaesthesia or as an immediate life-saving measure in patients with difficult or failed airway. The second generation SADs make two separate seals with respiratory and gastrointestinal tracts to reduce risk of pulmonary aspiration. Ambu AuraGain is a newer single use anatomically curved supraglottic airway device with a gastric conduit and intubation capability. The integrated gastric access channel is designed with a low friction inner surface to facilitate easy placement of a gastric tube. BlockBuster Laryngeal Mask Airway has a short airway tube which has angulation to match the oropharyngeal curve and thus makes the insertion easy and less traumatic. It also has a gastric conduit and intubation capability. It has a guidance device which directs the tracheal tube towards the laryngeal opening at an angle of 30 degrees which enhances rate of successful blind intubation. We hypothesis that BlockBuster Laryngeal Mask Airway has better efficacy for ventilation in terms of higher oropharyngeal seal pressure as compared to AmbuAuraGain in paediatric patients undergoing elective surgery under general anaesthesia. |