Comparison of the Baska Mask Airway to a Single-use LMA Device in Low-risk Female Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- John Laffey
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Rate of successful placement of the supraglottic device on first attempt
研究概览
简要总结
The purpose of this study is to compare the performance of the Baska mask supraglottic airway device with a single use laryngeal mask device (LMA) in low-risk female patients.
The investigators have performed a number of studies on novel airway devices, including 3 studies on the Baska mask. This trial will compare some performance characteristics of the studied devices, including airway seal pressures, insertion success rates, device use difficulty scores. Additional performance and device safety data will be accumulated.
The investigators have two primary hypotheses, namely 1.Non-inferiority of first placement attempt success rate of the Baska mask vs LMA; and 2.greater seal pressure of the Baska mask vs LMA.
详细描述
Supraglottic airway devices have established place in the airway management in patients undergoing general anesthesia.
The Baska mask is a new supraglottic airway device. It's features include:
- Non pressurized cuff designed to reduce the risk of oropharyngeal tissue damage.
- Improved cuff seal during the inspiratory phase of positive pressure ventilation
- An improved system for drainage of oropharyngeal contents intended to reduce the rate of lung aspiration.
- Integrated bite-block to reduce the risk of patients biting and blocking the airway.
This study is randomized, single-blinded, controlled trial. The participants will be allocated to two groups, in which either the Baska mask or the single use LMA will be the primary airway management device.
Clinical Research Ethics Committee approval has been obtained. Suitable participants will be recruited after written informed consent.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 16 Years 至 85 Years（Child, Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Written informed consent
- •No relevant allergies
- •Body-mass index (BMI) 35 or less
- •Age 16-85
- •Non-urgent surgery of planned duration under 4 hours
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
- •Predicted or previously documented difficult airway
- •Live Pregnancy
- •Increased risk for Gastric Aspiration
结局指标
主要结局
Rate of successful placement of the supraglottic device on first attempt
时间窗: within 30 minutes of commencement of general anesthesia
The hypothesis is that the Baska mask will have first time placement attempt success rate that is no more than 15% less than that of the comparator - a single use LMA device.
Seal pressure of the supraglottic device
时间窗: Within 30 minutes of commencement of general anesthesia
The investigators will measure the airway seal provided by the device used. The hypothesis is that the seal pressure of the Baska mask is 20% higher than that of the comparator single-use LMA device.
次要结局
- Overall rate of successful placement of the supraglottic device(Within 30 minutes of commencement of general anesthesia. Up to 3 device placement attempts are allowed.)
- Number of device placement attempts(Within 30 minutes of commencement of general anesthesia)
- Number of optimization maneuvers during device placement(Within 30 minutes of commencement of general anesthesia)
- user rated Device difficulty score(within 30 minutes of commencement of general anesthesia)
- vitals parameter stability(in the period immediately before and within the first 35 minutes of general anesthesia)
- Laryngeal view obtained on fiberoptic assessment(within 2 hours of commencement of general anesthesia)
- Complication rates(from the moment general anesthesia commenced up to 3 days postoperatively)
研究者
John Laffey
Professor of Anaesthesia and Critical Care, Consultant Anaesthetist
University College Hospital Galway