Efficacy of Baska Mask versus Proseal Laryngeal Mask Airway in elective surgeries under general anesthesia - a Randomized Controlled Trial
Overview
- Phase
- Phase 2/3
- Status
- Not yet recruiting
- Sponsor
- Dr. R. Ajisha Rachel
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- To measure time taken for insertion, ease of insertion and number of attempts for insertion between the Proseal Laryngeal Mask Airway and the Baska Mask
Overview
Brief Summary
The supraglottic airway devices (SAD) have drastically changed the face of airway management in patients undergoing anesthesia and have become a key component of modern airway management, especially in surgeries of short durations.
The Proseal Laryngeal Mask Airway (PLMA) is a reusable second generation SAD with an additional inflatable dorsal cuff, integrated bite block, and a gastric drain tube, while the Baska Mask (BM), a third generation SAD, possesses newer modified features such as a sump with two drains and a bite block throughout the entire length of the airway tube, which would lead to better clinical performance than the PLMA.
This study aims to compare the advantages and efficacy of Baska Mask (BM) over Proseal Laryngeal Mask Airway (PLMA) ) in adult patients undergoing elective surgery under general anesthesia with controlled ventilation.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- Participant Blinded
Eligibility Criteria
- Ages
- 18.00 Year(s) to 60.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Patients of either gender, from 18 to 60 years of age, belonging to the American Society of Anesthesiologists (ASA) classes I, II and III.
Exclusion Criteria
- •Patients refusal, BMI more than or equal to 30 kg per metre square, Restricted mouth opening, Surgeries lasting more than 2 hours, Burns and swelling in neck, High aspiration risk with poor pulmonary compliance.
Outcomes
Primary Outcomes
To measure time taken for insertion, ease of insertion and number of attempts for insertion between the Proseal Laryngeal Mask Airway and the Baska Mask
Time Frame: At start of insertion of both devices
Secondary Outcomes
- To measure oropharyngeal seal pressure (OSP) logged at two different times and post- insertion(complications between Baska Mask and Proseal Laryngeal Mask Airway)
Investigators
Dr R Ajisha Rachel
Sri Venkateshwaraa Medical College Hospital and Research Centre