Clinical trial NCT03002857: Comparison of I-gel LMA, Classical LMA With a New Supraglottic Airway the Baska Mask® in Urological Surgery
Official title: Comparison of I-gel LMA, Classical LMA With a New Supraglottic Airway the Baska Mask®in Urological Surgery Regarding Their Efficacy and Safety
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Airway Management
Keywords: Laryngeal Mask Airway
Urologic Surgical Procedure
Lead sponsor: Adiyaman University Research Hospital
Sponsor class: OTHER
Collaborators: name: Turkiye Yuksek Ihtisas Education and Research Hospital
First posted: 2016-12-26
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: The most used airway management strategies are different types of supraglottic airway devices (SAD) for transurethral resection of bladder and ureteroscopy in urological surgery . Classical laryngeal mask airway (LMA-C) and I-Gel SADs are being used already. The aim of this study was to evaluate and compare the performance of a new type of SAD the Baska Mask® with I-gel and LMA-C regarding their insertion times, durations, perioperative complications and effects on hemodynamic parameters, peak airway pressures (Paw) and airway plato pressures in urological surgery as well.

Detailed description: The most used airway management strategies are different types of supraglottic airway devices (SAD) for transurethral resection of bladder and ureteroscopy in urological surgery . Classical laryngeal mask airway (LMA-C) and I-Gel SADs are being used already. The aim of this study was to evaluate and compare the performance of a new type of SAD the Baska Mask® with I-gel and LMA-C regarding their insertion times, durations, perioperative complications and effects on hemodynamic parameters, peak airway pressures (Paw) and airway plato pressures in urological surgery as well.

The main suggestion about the Baska Mask® is that it's the most appropriate airway device with high Paws. In high Paws, higher air leaks may occur from the sides of cuff and this causes hypoventilation. So the main aim of this study is to evaltuate three devices in terms of insertion and ventilation times, the "first attempt" success rates, the additional maneuvering requirements and complications developed after intervention.

The secondary objective of the study was to evaluate all three SADs in terms of airway pressures producing sufficient tidal volume and hemodynamical parameters.

Eligibility criteria: Inclusion Criteria:

* (ASA) 1-2-3 physical status scheduled for elective surgical procedure for transurethral resection of bladder and ureteroscopy.

Exclusion Criteria:

* Under the age of 18, history of hiatus hernia, gastroesophageal reflux, body mass index (BMI) \> 30 kg m-2, ASA physical status 4 or over and patients who met the difficult intubation criteria.

Primary outcomes:
measure: Insertion times
timeFrame: Perioperative
measure: Ventilation times
timeFrame: Perioperative
measure: First attemp success rates
timeFrame: Perioperative
measure: The additional maneuvering
timeFrame: Perioperative
measure: Airway related complications
timeFrame: Perioperative
Secondary outcomes:
measure: Airway PAP and Plateau pressures
timeFrame: Perioperative
measure: Haemodynamic parameters, heart rate bpm, systolic and diastolic arterial pressures mmHg
timeFrame: Perioperative
Other outcomes:
Locations:
Study officials:
affiliation: Yuksek Ihtisas Research and Educational Hospital
name: Asli Demir
role: STUDY_DIRECTOR
References: