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

NCT ID: NCT03002857

Last Updated: 2017-05-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-09-30
• Study Completion Date: 2016-09-30

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.

Conditions

Airway Management

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

LMA-C

Intervention Type: DEVICE

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.

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.

Group Type: EXPERIMENTAL

I-gel

Intervention Type: DEVICE

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

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.

Group Type: EXPERIMENTAL

Baska Mask

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

I-gel

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

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Turkiye Yuksek Ihtisas Education and Research Hospital

OTHER_GOV

Sponsor Role: collaborator

Adiyaman University Research Hospital

OTHER

Sponsor Role: lead

Responsible Party

Dr. Ülkü Sabuncu

M.D.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Asli Demir

Role: STUDY_DIRECTOR

Yuksek Ihtisas Research and Educational Hospital

Other Identifiers

LMA-Urological surgery

Identifier Type: -

Identifier Source: org_study_id