Comparison of the Effectiveness of the BASKA Airway, a Novel Supraglottic Device, to the LMA Airway in Low Risk Female Patients
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 92
- 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 investigators have 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 proposed study the investigators would like to compare directly,in a randomized clinical trial, this device with the device the investigators routinely use - the single use laryngeal mask airway - LMA, in female patients undergoing general anaesthesia.
This study will determine which device performs best, as measured by key parameters (insertion success rate, seal pressures, time to and ease of insertion, failure rate, complications etc) as regarding the performance and safety profile of the Baska mask and the LMA.
The investigators have two study hypotheses, namely (1) non-inferiority of first placement attempt success rate of Baska vs LMA; and (2) greater seal pressure of the Baska mask vs LMA.
A number of secondary endpoints will be monitored and analyzed (time to and ease of insertion, failure rate, complications etc).
详细描述
Airway management is essential component of the safe and efficient provision of general anaesthesia. Supraglottic airway devices have established place in the airway management.
The Baska mask is a new supraglottic airway device. It bears many of the features of the industry standard - the laryngeal mask airway (LMA), with few potential improvements:
- The cuff is not pressurized thus reducing the risk of oropharyngeal tissue damage.
- Improved cuff seal during the inspiratory phase of positive pressure ventilation which may reduce leak and make ventilation more efficient.
- An improved system for drainage of oropharyngeal contents intended to reduce the rate of lung aspiration.
- The Baska mask is inserted in neutral head position thus reducing the need for neck manipulation.
- There is integrated bite-block to reduce the risk of patients biting and blocking the airway.
The results from the observational study of the performance of the Baska mask are promising and the investigators feel a randomized comparative study against the gold standard device, the Laryngeal Mask Airway (LMA) is justified.
This study is a randomized, single blinded, controlled clinical trial. The participants will be allocated to two groups, in which the investigators will use either a single use LMA device or the Baska mask (single use).
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) 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)
- •Predicted or previously documented difficult airway
- •Live Pregnancy
- •Increased risk for Gastric Aspiration
- •Current participation in another Clinical Study
结局指标
主要结局
Rate of successful placement of the supraglottic device on first attempt
时间窗: Within 30minutes of commencement of general anaesthesia
The hypothesis is that the BASKA mask will have first placement attempt success rate that is no more than 20% less than that of the single use LMA device.
Seal pressure of the supraglottic device
时间窗: Within 30minutes of commencement of general anaesthesia, immediately after successful placement is accomplished.
The investigators will measure the airway seal provided by the device used. The hypothesis is that the seal pressure with the BASKA mask will be 40% higher than that of the single use LMA.
次要结局
- Overall rate of successful placement of the supraglottic device(Within 30minutes of commencement of general anaesthesia. Up to 3 device placement attempts are allowed.)
- Number of device placement attempts(Within 30minutes of commencement of general anaesthesia)
- User - rated Ease of insertion of the device(Within 30minutes of commencement of general anaesthesia)
- vital parameters stability(In the period immediately before and during the first 35 minutes of the general anaesthesia)
- Laryngeal view obtained on fiberoptic assessment(within 2hours of commencement of general anaesthesia)
- User rated Ease of removal of the device(At the time of device removal (usually within 15 minutes before or after the end of the general anaesthesia))
- Complication rates(from the moment general anaesthesia commenced up to 3 days postoperatively)
- Duration of successful insertion attepts(Within 30 minutes of commencement of general anaesthesia)
研究者
John Laffey
Professor of Anaesthesia and Critical Care, Consultant Anaesthetist
University College Hospital Galway