FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2026/04/109458 [Registered on: 27/04/2026] Trial Registered Prospectively
Last Modified On: 25/04/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A study comparing the safety and effectiveness of two airway devices used during anesthesia (Blockbuster® and Proseal® laryngeal mask airways) in children under 7 years of age undergoing anesthesia, using a randomised study design 
Scientific Title of Study   Comparison of clinical performance of Blockbuster® Laryngeal mask airway and Proseal ® Laryngeal mask airway in anaesthetised children below 7 years- A randomised controlled trial. 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Gauthamme Sai L M 
Designation  Post Graduate Student  
Affiliation  Sri Ramachandra medical College and research Institute  
Address  Department of Anaesthesiology and Pain Medicine,Sri Ramachandra Medical College and Research Institute Sri Ramachandra Institute of Higher Education and Research Porur, Chennai

Chennai
TAMIL NADU
600116
India 
Phone  8056149454  
Fax    
Email  m2324017@sriher.edu.in  
 
Details of Contact Person
Scientific Query
 
Name  Dr Aruna Parameswari 
Designation  Head of department 
Affiliation  Sri Ramachandra Medical College and Research Institute  
Address  Department of Anaesthesiology and Pain Medicine, Sri Ramachandra Medical College and Research Institute, Sri Ramachandra Institute of Higher Education and Research Porur, Chennai

Chennai
TAMIL NADU
600116
India 
Phone  9840529863  
Fax    
Email  hod.anaesthesiology@sriramachandra.edu.in  
 
Details of Contact Person
Public Query
 
Name  Dr Aruna Parameswari 
Designation  Head of department 
Affiliation  Sri Ramachandra Medical College and Research Institute  
Address  Department of Anaesthesiology and Pain Medicine, Sri Ramachandra Medical College and Research Institute, Sri Ramachandra Institute of Higher Education and Research Porur, Chennai

Chennai
TAMIL NADU
600116
India 
Phone  9840529863  
Fax    
Email  hod.anaesthesiology@sriramachandra.edu.in  
 
Source of Monetary or Material Support  
Sri Ramachandra Institute of Higher Education and Research  
 
Primary Sponsor  
Name  Sri Ramachandra Institute of Higher Education and Research  
Address  Sri Ramachandra Institute of Higher Education and Research,Porur Chennai 600116 
Type of Sponsor  Research institution and hospital 
 
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 Gauthamme Sai  Sri Ramachandra Medical centre  A6 OR complex,Department of Anaesthesia,Sri Ramachandra Institute of Higher Education and Research,Chennai Porur 6000116
Chennai
TAMIL NADU 
8056149454

m2324017@sriher.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee,Sri Ramachandra Institute of higher education and research,Porur,Chennai 600116  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: 4||Measurement and Monitoring, (2) ICD-10 Condition: R688||Other general symptoms and signs,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Blockbuster laryngeal mask airway and Proseal laryngeal mask airway  Comparison between clinical performance of Blockbuster and Proseal laryngeal mask airway 
Intervention  Oropharyngeal leak pressure  Oropharyngeal leak pressure(OLP) is defined as the pressure in the anaesthesia breathing circuit at which gas leak occurs around the SGA device and will be determined one minute after securing the airway by closing the expiratory valve of the circle system up to 30 cm H2O ,at a fresh gas flow 3 Litres per minute and observing the airway pressure at equilibrium by auscultating the leak sound over the thyroid cartilage using a stethoscope.To ensure safety, maximum allowable Oropharyngeal seal pressure will be set at 40 cm H2O, and adjustable pressure limiting valve pressure will be released if there is no audible leak even at maximum allowable pressure. The duration of measurement is for one minute. 
 
Inclusion Criteria  
Age From  1.00 Year(s)
Age To  7.00 Year(s)
Gender  Both 
Details  Children of age group 1 to 7 years of either gender

American Society of Anaesthesiologist physical status I and II scheduled for elective surgery under general anaesthesia
 
 
ExclusionCriteria 
Details  Anticipated difficult airway
Syndromic children
Children with upper and lower respiratory tract infections
Distorted upper airway anatomy or upper airway obstruction
Children undergoing emergency surgery
Risk of Aspiration(full stomach, history of stomach surgery, hiatal hernia etc)
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
The primary outcome will be to compare the oropharyngeal leak pressure of Blockbuster and Proseal laryngeal mask airway   At baseline after supraglottic airway device has been secured  
 
Secondary Outcome  
Outcome  TimePoints 
Mean insertion time
Ease of supraglottic airway device insertion
Fibreoptic view of vocal cord through the Laryngeal mask airway
Ease of gastric tube placement
The presence of blood on the device at the end of removal 
At baseline  
 
Target Sample Size   Total Sample Size="32"
Sample Size from India="32" 
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 3/ Phase 4 
Date of First Enrollment (India)   06/05/2026 
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="0"
Months="3"
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  

Endotracheal intubation is the definitive airway for ventilation and prevention of aspiration during general anaesthesia, but the invention of supraglottic airway devices has changed the focus of airway management during general anaesthesia from intubation to oxygenation and ventilation.The use of supraglottic airway devices for securing the airway in paediatric patients undergoing surgery has become popular thereby decreasing the perioperative airway complications.However safety and clinical performance of these devices has still not been properly established in paediatric population.The aim of the study is to compare the efficacy of  Blockbuster® Laryngeal mask airway and Proseal® Laryngeal mask airway. It is a Prospective Single blinded Randomised Controlled study. After obtaining Institution Ethics Committee approval pediatric patients who fit into the inclusion criteria will be enrolled into the study after obtaining informed consent from the parents. Patients will be randomly allocated into two groups by using computer generated block randomization table. Group A- Blockbuster LMA Group B – Proseal LMA.Baseline vitals – heart rate, oxygen saturation, and blood pressure will be monitored.After three minutes of preoxygenation the lubricated supraglottic airway device (SGA) will be inserted into child’s mouth with head in neutral position as per the allocated group.The appropriate size of the SGA device will be selected as per the manufacturer’s recommendation.Cuff of the device will be inflated with adequate volume of air as per the manufacturer’s recommendation. After confirmation of the position of the supraglottic airway device it will be fixed and connected to the ventilator with appropriate ventilator settings and the required depth of anaesthesia will be maintained.Then the oropharyngeal leak pressure will be measured,which is defined as the pressure in the anaesthesia breathing circuit at which gas leak occurs around the Supra glottic airway device.To ensure safety, maximum allowable Oropharyngeal seal pressure will be set at 40 cm H2O, and adjustable pressure limiting valve pressure will be released if there is no audible leak even at maximum allowable pressure. Mean Insertion time,Ease of supraglottic airway device insertion,Fibreoptic view of vocal cord through the LMA ,Ease of gastric tube placement ,The presence of blood on the device at the end of removal will also be noted.The parameters observed will be compared between the two groups and statistical analysis will be done.This study will help compare the clinical performance of two different airway devices in pediatric population.



 



 
Close