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CTRI Number  CTRI/2025/07/091221 [Registered on: 21/07/2025] Trial Registered Prospectively
Last Modified On: 16/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparing Two Ways to Insert a Breathing Device (LMA): Using a Bougie Tool vs the Regular Method – A Randomized Comparative Study 
Scientific Title of Study   Comparison of Bougie guided Insertion of Blockbuster LMA Versus Conventional method in successful placement of LMA – A Randomised 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  Dr Swetha P  
Designation  Professor and Guide 
Affiliation  Subbiah Institute of Medical Science  
Address  Department of Anesthesia 2 nd floor OT Complex Subbiah institute of medical Science Purle Shimoga

Shimoga
KARNATAKA
577222
India 
Phone  8151065298  
Fax    
Email  swethabadami84@gmail.com   
 
Details of Contact Person
Scientific Query  
Name  Dr Swetha P  
Designation  Professor and Guide 
Affiliation  Subbiah Institute of Medical Science  
Address  Department of Anesthesia 2 nd floor OT Complex Subbiah institute of medical Science Purle Shimoga

Shimoga
KARNATAKA
577222
India 
Phone  8151065298  
Fax    
Email  swethabadami84@gmail.com   
 
Details of Contact Person
Public Query  
Name  Dr Raveesh J R  
Designation  PG Student  
Affiliation  Subbiah Institute of Medical Sciences  
Address  Department of Anesthesia 2 nd floor OT Complex Subbiah institute of medical Science Purle Shimoga

Shimoga
KARNATAKA
577222
India 
Phone  9008231922  
Fax    
Email  raveeshjr1987@gmail.com   
 
Source of Monetary or Material Support  
subbiah institute of medical science Purle Shimoga Karnataka India 577222  
 
Primary Sponsor  
Name  Subbiah Institute of Medical Science 
Address  purle shimoga India 577222 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Swetha  subbiah institute of medical science  Department of Anesthesia 2 nd floor OT Complex Subbiah institute of medical Science Purle Shimoga
Shimoga
KARNATAKA 		 8151065298

swethabadami84@gmail.com  
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Subbiah Institute of Medical Science   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: 2||Placement,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Bougie guided placement of LMA  Railloading of LMA over bougie using laryngoscope inside the oral cavity of patient for maintaining airway during ot. 
Comparator Agent  Digital insertion method   placing of LMA using forefinger inside the oral cavity of patient for maintaining airway during ot. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  American Society of Anesthesiologist Physical status 1 and 2
Modified mallampatti 1 and 2 
 
ExclusionCriteria 
Details  American Society of Anesthesiologist Physical status 3 and 4
Modified mallampatti 3 and 4
Pregnant women
Obesity with BMI greater than 30
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Number of attempts for successful placement of LMA
 		 3 attempts 
 
Secondary Outcome  
Outcome  TimePoints 

1) Duration for a successful placement of Blockbuster LMA
2) Hemodynamic response to insertion
3) Airway trauma during insertion
4) Presence of visible blood staining on laryngoscope blade, LMA & bougie.
5) Post-operative complications like sore throat,dysphagia & dysphonia.  		 within 24 hrs 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/08/2025 
Date of Study Completion (India) 28/02/2026 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
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 a key skill in anesthesiology. Till 1980s only face mask and endotracheal tubes were available. The introduction of Laryngeal mask airway revolutionised practise. Blockbuster Laryngeal mask airway features a more angulated airway and gastric port offering improved sealing and ease of intubation.Studies suggest bougie guided insertion improves success rates over digital methods with classical Laryngeal mask airway i.e LMA.Limited research exists on this technique with Blockbuster LMA prompting further investigation. 
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