| CTRI Number |
CTRI/2025/09/095035 [Registered on: 18/09/2025] Trial Registered Prospectively |
| Last Modified On: |
12/09/2025 |
| 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
|
Study to compare two devices for control of breathing during operation for various surgeries |
|
Scientific Title of Study
|
Comparison of oropharyngeal leak pressure of Blockbuster® Laryngeal Mask Airway with Laryngeal Mask Airway Proseal™ in children: A randomized comparative study. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Zeeba Taranum |
| Designation |
PG Resident |
| Affiliation |
MS Ramaiah Medical College |
| Address |
Department of Anaesthesiology Second Floor
MS Ramaiah Medical College Hospital
MSRIT Post
New BEL Road
Bangalore
Bangalore
KARNATAKA
560054
India |
| Phone |
9113547038 |
| Fax |
|
| Email |
zeebataranum06@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Tejesh C A |
| Designation |
Professor |
| Affiliation |
MS Ramaiah Medical College |
| Address |
Department of Anaesthesiology Second Floor
MS Ramaiah Medical College Hospital
MSRIT Post
New BEL Road
Bangalore
Bangalore
KARNATAKA
560054
India |
| Phone |
9886481848 |
| Fax |
|
| Email |
drtejeshca@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Tejesh C A |
| Designation |
Professor |
| Affiliation |
MS Ramaiah Medical College |
| Address |
Department of Anaesthesiology Second Floor
MS Ramaiah Medical College Hospital
MSRIT Post
New BEL Road
Bangalore
Bangalore
KARNATAKA
560054
India |
| Phone |
9886481848 |
| Fax |
|
| Email |
drtejeshca@yahoo.com |
|
|
Source of Monetary or Material Support
|
| MS Ramaiah Medical College
Bangalore |
|
|
Primary Sponsor
|
| Name |
MS Ramaiah Medical College Bangalore MSRIT Post New BEL Road Bangalore 560054 |
| Address |
MS Ramaiah Medical College
MSRIT Post
New BEL Road
Bangalore 560054 |
| 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 |
| Zeeba Taranum |
MS Ramaiah Medical College |
Department of Anaesthesiology Second Floor MS Ramaiah Medical College Hospital New BEL Road Bangalore
Bangalore
KARNATAKA |
9113547038
zeebataranum06@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| MS Ramaiah Medical College Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Children who are scheduled to undergo various surgeries of duration lasting less than 2 hours |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Blockbuster® Laryngeal Mask Airway |
Inserted after induction of anaesthesia ,cuff inflated to intracuff pressure of 60cmH20, correct position checked with chest rise, auscultation ,capnography,and absence of gastric insufflation |
| Comparator Agent |
Laryngeal Mask Airway Proseal™ |
Inserted after induction of anaesthesia, cuff inflated to intracuff pressure of 60cmH20, correct position checked with chest rise,auscultation, capnography,and absence of gastric insufflation |
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
10.00 Year(s) |
| Gender |
Both |
| Details |
American Society of Anaesthesiologists (ASA) physical status 1 and 2 |
|
| ExclusionCriteria |
| Details |
Laparoscopic surgeries
History of obstructive sleep apnoea
Intraoral surgeries
Increased risk of aspiration
Anticipated difficult airway
Surgery in positions other than supine
Upper airway pathology
Abnormal upper airway anatomy |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Comparison of oropharyngeal leak pressure of Blockbuster® Laryngeal Mask Airway with Laryngeal Mask Airway Proseal™ in children under controlled ventilation |
5 minutes after the insertion of the device |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Compare Blockbuster® Laryngeal Mask Airway with Laryngeal Mask Airway Proseal™ with respect to
Ease of insertion
Insertion time
Number of attempts at insertion
Fibreoptic view of glottis |
5 minutes after insertion of the device |
|
|
Target Sample Size
|
Total Sample Size="92"
Sample Size from India="92"
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)
|
01/10/2025 |
| 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="2"
Months="0"
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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - None of the above
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [zeebataranum06@gmail.com].
- For how long will this data be available start date provided 04-01-2028 and end date provided 04-01-2033?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Supraglottic airway devices (SADs) have now become the commonly used modality of airway management not only in adults but in children undergoing elective surgical procedures under general anaesthesia. They not only provide adequate ventilation and oxygenation but are also associated with lower respiratory related adverse events, thus replacing the need for tracheal intubation in children. a. The popularity of the SADs has led to various modification in the design as well as in the material used since its first introduction into clinical anaesthesia by Archie Brain. Blockbuster® LMA is a recent addition to the armamentarium of SADs. It is made of medical grade silicone with an anatomically shaped airway tube. The cuff of the device is made of silicone which is more elastic and malleable, thus thought to provide a high sealing pressure. The LMA Proseal™ with its unique design features is regarded as the state-of-the-art SAD and is compared with all latest SADs. The LMA Proseal™ is the commonly used SAD in children in our institution. There is paucity of literature comparing BlockBuster® LMA with LMA Proseal™ in children. The hypothesis of this study is that the BlockBuster® LMA will provide a higher oropharyngeal leak pressure than LMA Proseal™ in children undergoing elective short-duration surgeries under general anaesthesia. |