跳至主要内容
临床试验/NCT03002857
NCT03002857已完成不适用

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

Adiyaman University Research Hospital0 个研究点目标入组 150 人开始时间: 2015年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
150
主要终点
Insertion times

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Other
盲法
Double (Participant, Investigator)

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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.

结局指标

主要结局

Insertion times

时间窗: Perioperative

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

Ventilation times

时间窗: Perioperative

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

First attemp success rates

时间窗: Perioperative

In how many patients it was inserted at first attempt

The additional maneuvering

时间窗: Perioperative

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

Airway related complications

时间窗: 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.

次要结局

  • Airway PAP and Plateau pressures(Perioperative)
  • Haemodynamic parameters, heart rate bpm, systolic and diastolic arterial pressures mmHg(Perioperative)

研究者

发起方
Adiyaman University Research Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. Ülkü Sabuncu

M.D.

Adiyaman University Research Hospital

相似试验