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

Sponsor
Adiyaman University Research Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT03002857
Collaborator
Turkiye Yuksek Ihtisas Education and Research Hospital (Other)
150
3
12

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: LMA-C
  • Device: Baska Mask
  • Device: I-gel
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
150 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Other
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
Study Start Date :
Sep 1, 2015
Actual Primary Completion Date :
Sep 1, 2016
Actual Study Completion Date :
Sep 1, 2016

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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.

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.

Experimental: 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.

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

Experimental: 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.

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.

Outcome Measures

Primary Outcome Measures

  1. Insertion times [Perioperative]

    It was evaluated that how many secs does it take to insert properly.

  2. Ventilation times [Perioperative]

    It was evaluated that how many secs does it take to ventilate the patient.

  3. First attemp success rates [Perioperative]

    In how many patients it was inserted at first attempt

  4. The additional maneuvering [Perioperative]

    ıt was evaluated how many maneuvers needed to insert the device.

  5. 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

  1. Airway PAP and Plateau pressures [Perioperative]

    Both pressures were evaluated following device insertion and then in every 10 mins.

  2. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 90 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Adiyaman University Research Hospital
  • Turkiye Yuksek Ihtisas Education and Research Hospital

Investigators

  • Study Director: Asli Demir, Yuksek Ihtisas Research and Educational Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Dr. Ülkü Sabuncu, M.D., Adiyaman University Research Hospital
ClinicalTrials.gov Identifier:
NCT03002857
Other Study ID Numbers:
  • LMA-Urological surgery
First Posted:
Dec 26, 2016
Last Update Posted:
May 9, 2017
Last Verified:
May 1, 2017
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Keywords provided by Dr. Ülkü Sabuncu, M.D., Adiyaman University Research Hospital

Study Results

No Results Posted as of May 9, 2017