| 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
|
|
|
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
|
|
|
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.
|