PSA Extraglottic Airway for Positive Pressure Ventilation (Pharachute Supralaryngeal Airway)
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Satisfactory positive pressure ventilation: Maximum airway inflation pressure
研究概览
简要总结
The Pharachute Supralaryngeal Airway (PSA) is an extraglottic airway device (EAD) for routine use in anaesthesia.
The plan is to do a pilot study on a minimum of 20 and maximum of 30 participants whose fitness status is ASA 1 or 2 for whom this type of airway management is routinely used. When the participants are asleep the airway will be inserted, with ease of insertion and satisfactory positive pressure ventilation assessed. This will be indicated by minimal threshold leak from the breathing system and the seal pressure that can be achieved. Any side-effects will be assessed post-operatively.
详细描述
The proposed research is non-commercial. No extraglottic airways are good enough to displace the use of tracheal tubes, currently used in 40+% of general anaesthesia. Anaesthesia requiring tracheal tube intubation is associated with 0.1% with permanent voice changes1. That means, 800 people per annum in the UK will suffer permanent voice changes. Reduction of the use of tracheal tubes to 10% will reduce this problem by 600 per annum. The PSA device is a new extraglottic airway designed with the purpose of achieving better sealing pressures safely because of a different sealing site and self-energizing sealing mechanism and a better prevention of the risk of aspiration in the presence of regurgitation. Therefore, it has the potential to make a huge difference to patients. As a first step in this objective, the investigators need to find out whether the airway device is predictably reliable and whether the seal pressures are good enough for positive pressure ventilation.
- Research hypothesis
The PSA is a reliable extraglottic airway that can be inserted easily, atraumatically and achieves reliable sealing pressures that will allow for positive pressure ventilation.
- Research questions
Concerning the use of the PSA in 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
- Other
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 85 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Anatomical sizing criterion
排除标准
- •Emergency participants Suspected full stomach
- •Mentally incompetent patients
- •Patients who are requiring head and neck surgery
- •Morbidly obese patients
结局指标
主要结局
Satisfactory positive pressure ventilation: Maximum airway inflation pressure
时间窗: Assessed by the anesthesiologist within first 120 seconds of inserting the device.
Maximum airway inflation pressure that can be achieved before a significant leak becomes apparent must exceed 14 cm water pressure.
1.PSA Ease of insertion It should be adequate and reliable [Time Frame: Assessed by the anesthesiologist within first 60 seconds of inserting the device.]
时间窗: Assessed by the anesthesiologist within first 60 seconds of inserting the device.
Time taken to achieve adequate airway
次要结局
- Watching for possible unanticipated serious side effects from airway usage(Within the first 24 hours)