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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03002857

Acronym

BCIM

Enrollment

150

Registered

2016-12-26

Start date

2015-09-30

Completion date

2016-09-30

Last updated

2017-05-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Airway Management

Keywords

Laryngeal Mask Airway, Urologic Surgical Procedure

Brief summary

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.

Interventions

DEVICELMA-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.

DEVICEBaska 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.

DEVICEI-gel

I-gel LMA placement will be done as suggested in supine position with a standard gel pillow under patients head.

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

OTHER

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 90 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Ventilation times	Perioperative	It was evaluated that how many secs does it take to ventilate the patient.
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.
Insertion times	Perioperative	It was evaluated that how many secs does it take to insert properly.
First attemp success rates	Perioperative	In how many patients it was inserted at first attempt

Secondary

Measure	Time frame	Description
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.
Airway PAP and Plateau pressures	Perioperative	Both pressures were evaluated following device insertion and then in every 10 mins.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026