Observational Study of Baska Mask, a New Supraglottic Airway Device
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Device Placement Success rate
研究概览
简要总结
The Baska mask is a new supraglottic airway device . The investigators would like to assess its performance in setting in which the current standard - LMA device - is being used.
详细描述
Our group has performed a number of studies on novel airway devices. In this study we would like to evaluate a new supraglottic airway named Baska mask. We would like to monitor certain parameters (time to and ease of insertion, failure rate, seal pressures, complications etc) as regarding the performance and safety profile of this device. This is a descriptive case series of patients undergoing airway management under general anaesthesia.
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed Consent
- •No relevant drug allergies
- •Body-mass index (BMI) 20-35
- •Age 18-65
- •Non-urgent surgery of planned duration 0-2 hrs
排除标准
- •Inability of patient/parent to understand or consent for the trial
- •Non-English speakers
- •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 etc)
- •Expected Difficult airway
- •Live Pregnancy
- •Increased risk for Gastric Aspiration
结局指标
主要结局
Device Placement Success rate
时间窗: within 30 mins of anaesthesia commencement
time to placement of device
时间窗: within 30 mins of anaesthesia commencement
from the moment the device touched until successful ventilation achieved or device removed
次要结局
- user-rated ease of insertion of device(within 30 mins of anaestesia commencement)
- airway leak pressure of the device(within 30 mins of anaesthetic commencement)
- complication rates(From the moment general anaesthesia commenced up to 1 day postoperatively)
- patient comfort indices(from the moment the patient awake up to 1 day postoperatively)
研究者
John Laffey
Professor of Anaesthesia and Critical Care, Consultant Anaesthetist
University College Hospital Galway