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

NCT03002857 | Completed

• 1 other identifier: LMA-Urological surgery
• Study Type: interventional
• Target: 150
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Airway Management

Keywords

Laryngeal Mask Airway; Urologic Surgical Procedure

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (2)

• Airway PAP and Plateau pressures

  Perioperative

• Haemodynamic parameters, heart rate bpm, systolic and diastolic arterial pressures mmHg

  Perioperative

Study Arms (3)

Classical LMA

EXPERIMENTAL

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

I-gel

EXPERIMENTAL

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

The Baska Mask®

EXPERIMENTAL

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

Interventions

LMA-C 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.

Classical LMA

Baska Mask 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.

The Baska Mask®

I-gel DEVICE

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

I-gel

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (ASA) 1-2-3 physical status scheduled for elective surgical procedure for transurethral resection of bladder and ureteroscopy.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Adiyaman University Research Hospital: lead
• Turkiye Yuksek Ihtisas Education and Research Hospital: collaborator

Study Officials

• Asli Demir

  Yuksek Ihtisas Research and Educational Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.

Study Record Dates

• First Submitted: December 17, 2016
• First Posted: December 26, 2016
• Study Start: September 1, 2015
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: May 9, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share