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Clinical Trials/CTRI/2025/09/095035
CTRI/2025/09/095035
Not yet recruiting
Not Applicable

Comparison of oropharyngeal leak pressure of Blockbuster® Laryngeal Mask Airway with Laryngeal Mask Airway Proseal™ in children: A randomized comparative study.

MS Ramaiah Medical College Bangalore MSRIT Post New BEL Road Bangalore 5600541 site in 1 country92 target enrollmentStarted: October 1, 2025Last updated:

Overview

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
MS Ramaiah Medical College Bangalore MSRIT Post New BEL Road Bangalore 560054
Enrollment
92
Locations
1
Primary Endpoint
Comparison of oropharyngeal leak pressure of Blockbuster® Laryngeal Mask Airway with Laryngeal Mask Airway Proseal™ in children under controlled ventilation

Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Masking
Participant Blinded

Eligibility Criteria

Ages
2.00 Year(s) to 10.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • American Society of Anaesthesiologists (ASA) physical status 1 and 2.

Exclusion Criteria

  • 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.

Outcomes

Primary Outcomes

Comparison of oropharyngeal leak pressure of Blockbuster® Laryngeal Mask Airway with Laryngeal Mask Airway Proseal™ in children under controlled ventilation

Time Frame: 5 minutes after the insertion of the device

Secondary Outcomes

  • Compare Blockbuster® Laryngeal Mask Airway with Laryngeal Mask Airway Proseal™ with respect to(Ease of insertion)

Investigators

Sponsor
MS Ramaiah Medical College Bangalore MSRIT Post New BEL Road Bangalore 560054
Sponsor Class
Private medical college
Responsible Party
Principal Investigator
Principal Investigator

Zeeba Taranum

MS Ramaiah Medical College

Study Sites (1)

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