Comparison of I-gel LMA, Classical LMA With a New Supraglottic Airway the Baska Mask® in Urological Surgery (BCIM)

Comparison of I-gel LMA, Classical LMA With a New Supraglottic Airway the Baska Mask®in Urological Surgery Regarding Their Efficacy and Safety

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.

Study Overview

• Status: Completed
• Conditions: Airway Management
• Intervention / Treatment: Device: LMA-C; Device: I-gel; Device: Baska Mask

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.

• Study Type: Interventional
• Enrollment (Actual): 150
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: DOUBLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Classical LMA; Classical LMA insertion: LMA-C insertion was done in supine position and with a standard gel pillow with the patient's head on following anesthesia induction. The insertion was verified with the manual ventilation of the patient and end-tidal carbon dioxide pressure waveform.	Device: LMA-C; LMA-C will be placed into the patients airway following anesthesia induction. The placement will be done as suggested in supine position with a standard gel pillow under patients head.
EXPERIMENTAL: I-gel; I-gel LMA insertion: The I-gel LMA insertion was done in supine position and with a standard gel pillow with the patient's head on following anesthesia induction. The insertion was verified with the manual ventilation of the patient and end-tidal carbon dioxide pressure waveform.	Device: I-gel; I-gel LMA placement will be done as suggested in supine position with a standard gel pillow under patients head.
EXPERIMENTAL: The Baska Mask®; The Baska Mask® insertion: The Baska Mask® insertion was done in supine position and with a standard gel pillow with the patient's head on following anesthesia induction. The insertion was verified with the manual ventilation of the patient and end-tidal carbon dioxide pressure waveform.	Device: Baska Mask; Baska Mask will be placed into the patients airway following anesthesia induction. The placement will be done as suggested in supine position with a standard gel pillow under patients head.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Insertion times	It was evaluated that how many secs does it take to insert properly.	Perioperative
Ventilation times	It was evaluated that how many secs does it take to ventilate the patient.	Perioperative
First attemp success rates	In how many patients it was inserted at first attempt	Perioperative
The additional maneuvering	ıt was evaluated how many maneuvers needed to insert the device.	Perioperative
Airway related complications	Complications like Bloodstain of the mask, Dysphagia, Tongue injury, Lips injury, Teeth injury, Palate injury, Sore throat, Hoarseness, Desaturation , Laryngospasm, Regurgitation/aspiration were evaluated.	Perioperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Airway PAP and Plateau pressures	Both pressures were evaluated following device insertion and then in every 10 mins.	Perioperative
Haemodynamic parameters, heart rate bpm, systolic and diastolic arterial pressures mmHg	Preoperative and following device insertion all haemodynamic parameters were evaluated in every 10 mins.	Perioperative

Collaborators and Investigators

• Sponsor: Adiyaman University Research Hospital
• Collaborators: Turkiye Yuksek Ihtisas Education and Research Hospital
• Investigators: Study Director: Asli Demir, Yuksek Ihtisas Research and Educational Hospital

Study record dates

Study Major Dates

• Study Start: September 1, 2015
• Primary Completion (ACTUAL): September 1, 2016
• Study Completion (ACTUAL): September 1, 2016

Study Registration Dates

• First Submitted: December 17, 2016
• First Submitted That Met QC Criteria: December 21, 2016
• First Posted (ESTIMATE): December 26, 2016

Study Record Updates

• Last Update Posted (ACTUAL): May 9, 2017
• Last Update Submitted That Met QC Criteria: May 6, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: Laryngeal Mask Airway; Urologic Surgical Procedure
• Other Study ID Numbers: LMA-Urological surgery

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO