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

Not Applicable

Completed

• Conditions: Airway Management
• Interventions: Device: LMA-C; Device: I-gel; Device: Baska Mask

• Registration Number: NCT03002857
• Lead Sponsor: Adiyaman University Research Hospital

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.

Study Timeline

• Study Start: 2015-09
• Primary Completion: 2016-09
• Study Completion: 2016-09
• Study First Submitted: 2016-12-17
• Study First Submitted QC: 2016-12-21
• Study First Posted: 2016-12-26
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-06
• Last Update Posted: 2017-05-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Classical LMA	LMA-C	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.
I-gel	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.
The Baska Mask®	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.

Primary Outcome Measures

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

Secondary Outcome Measures

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