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NCT Number: NCT03002857

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

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.

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Key information

Conditions

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

I-gel

Device

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

Primary outcomes

  1. Insertion times

    Time frame: Perioperative

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

  2. Ventilation times

    Time frame: Perioperative

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

  3. First attemp success rates

    Time frame: Perioperative

    In how many patients it was inserted at first attempt

  4. The additional maneuvering

    Time frame: Perioperative

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

  5. Airway related complications

    Time frame: 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 outcomes

  1. Airway PAP and Plateau pressures

    Time frame: 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

    Time frame: Perioperative

    Preoperative and following device insertion all haemodynamic parameters were evaluated in every 10 mins.

Sponsors and collaborators

Lead sponsor

Adiyaman University Research Hospital

Other

Collaborators

  • Turkiye Yuksek Ihtisas Education and Research Hospital

Registry information

Official study title

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

Acronym: BCIM

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Dec 26, 2016
Registry last updated
May 9, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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