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

Comparison of clinical performance of Blockbuster Laryngeal mask airway and Proseal Laryngeal mask airway in anaesthetised children below 7 years- A randomised controlled trial. - Nil

Status

Active, not recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2026/04/109458

Enrollment

Registered

2026-04-27

Start date

Unknown

Completion date

Unknown

Last updated

2026-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: 4- Measurement and Monitoring Health Condition 2: R688- Other general symptoms and signs

Interventions

Intervention1: 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

Eligibility

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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)

Design outcomes

Primary

Measure	Time frame
The primary outcome will be to compare the oropharyngeal leak pressure of Blockbuster and Proseal laryngeal mask airwayTimepoint: At baseline after supraglottic airway device has been secured	—

Secondary

Measure	Time frame
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 removalTimepoint: At baseline	—

Countries

India

Contacts

Public ContactDr Aruna Parameswari

Sri Ramachandra Medical College and Research Institute

hod.anaesthesiology@sriramachandra.edu.in9840529863

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Jun 11, 2026