Determination of the Optimal Approach to Select the Best Size of BASKA Mask to Use in Male Patients
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Determination of the best predictor for successful Baska mask size
研究概览
简要总结
The investigators group has performed a number of studies on novel airway devices, including an observational study on the performance of a new supraglottic airway named Baska mask. In this new study the investigators wish to determine which criteria best predict the correct size of the Baska mask to be used in male patients
详细描述
Our observational study of the performance of the Baska mask suggests that this novel supraglottic airway has promise as an alternative to the current standard device, the laryngeal mask airway (LMA). Our results indicate that while the manufacturer weight criteria work reasonably well in females this may not be the case in males. The investigators wish to determine how well the manufacturer recommended sizing criteria for the Baska mask work in males.
This study is designed to determine which criteria best predict the correct size Baska mask to use in male patients. In addition the investigators will monitor the performance and safety of this device (insertion success rate, seal pressures, time to and ease of insertion, failure rate, complications etc)
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 85 Years（Child, Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Written informed consent
- •No relevant allergies
- •Body-mass index (BMI) 20-35
- •Age 16-85
- •Non-urgent surgery of planned duration 0.25-4 hrs
排除标准
- •Inability of patient/parent to understand or consent for the trial
- •Neck pathology
- •Previous or anticipated problems with the upper airway or upper GI tract (reflux, hiatus hernia, oropharyngeal tumour, upper respiratory tract infection in the last 10 days)
- •BMI > 35
- •Predicted or previously documented difficult airway
- •Increased risk for Gastric Aspiration
- •Current participation in another Clinical Study
结局指标
主要结局
Determination of the best predictor for successful Baska mask size
时间窗: From the moment of preoperative assessment until the moment of mask placement, an expected average of 3 hours.
We will evaluate the correlation between certain patient characteristics (including, but not limited, to actual and ideal body weight; height) and the size of the Baska mask used successfully in each patient.
次要结局
- insertion success rate of the device(within 30 min of anaesthesia commencement)
- device airway leak pressure(within 30 min of anaesthesia commencement)
- device insertion time(within 30 min of anaesthesia commencement)
- ease of insertion of device(within 30 min of anaesthesia commencement)
- complications(from the moment anaesthesia commenced up to the first postoperative day, an expected average of 30 hours.)
- Patient comfort(from the moment patient awake up to third postoperative day, an expected average of 80 hours.)
研究者
John Laffey
Professor of Anaesthesia and Critical care, Consultant Anaesthetist
University College Hospital Galway