Comparison of oropharyngeal leak pressure of Blockbuster® Laryngeal Mask Airway with Laryngeal Mask Airway Proseal™ in children: A randomized comparative study.
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
Zeeba Taranum
MS Ramaiah Medical College