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

Airway Management Clinical Trial

— BCIM  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03002857
• Other study ID #: LMA-Urological surgery
• Status: Completed
• Phase: N/A
• First received: December 17, 2016
• Last updated: May 6, 2017
• Start date: September 2015
• Est. completion date: September 2016

Study information

• Verified date: May 2017
• Source: Adiyaman University Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Airway Management

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Adiyaman University Research Hospital	Turkiye Yuksek Ihtisas Education and Research Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Insertion times	It was evaluated that how many secs does it take to insert properly.	Perioperative
Primary	Ventilation times	It was evaluated that how many secs does it take to ventilate the patient.	Perioperative
Primary	First attemp success rates	In how many patients it was inserted at first attempt	Perioperative
Primary	The additional maneuvering	it was evaluated how many maneuvers needed to insert the device.	Perioperative
Primary	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	Airway PAP and Plateau pressures	Both pressures were evaluated following device insertion and then in every 10 mins.	Perioperative
Secondary	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