The Air-Q Intubating Laryngeal Airway Versus the LMA-Proseal: A Prospective, Randomized Trial of Airway Seal Pressure
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Airway Seal Pressure
研究概览
简要总结
Introduction:
The air-QⓇ Intubating Laryngeal Airway (ILA) is a newer supraglottic airway. It is approved for use as a primary airway and as an aid for intubation in situations of anticipated or unanticipated difficult airways. A unique feature of this device as compared to other airways on the market is the size of the inner diameter (ID) and length of its airway tube. Direct placement of tracheal tubes > 7.5 mm ID through the airway tube is possible.
The ProSealTM LMA is considered the gold standard for supraglottic devices with respect to airway seal pressure. On average, it is reported to be approximately 28 cmH2O. This is significantly higher than that of the first generation LMA, the LMA-ClassicTM, which has a maximum seal pressure of 20 cmH2O, but averages 16-18 cmH2O in actual practice.
In this study the investigators aim to test whether the air-QⓇ creates an airway seal pressure that is similar to the LMA-ProSealTM, whether the position of the air-QⓇ in relation to the vocal cords, as assessed by fiberoptic endoscopy, is similar to that of the LMA-ProSealTM and whether airway morbidity is similar between the air-QⓇ and the LMA-ProSealTM.
详细描述
Introduction:
The air-QⓇ Intubating Laryngeal Airway (ILA) (Mercury Medical, Clearwater, Fl.) is a newer supraglottic airway. It is approved for use as a primary airway and as an aid for intubation in situations of anticipated or unanticipated difficult airways. A unique feature of this device as compared to other airways on the market is the size of the inner diameter (ID) and length of its airway tube. Direct placement of tracheal tubes > 7.5 mm ID through the airway tube is possible.
The ProSealTM LMA (LMA North America, La Jolla, CA) is considered the gold standard for supraglottic devices with respect to airway seal pressure. On average, it is reported to be approximately 28 cmH2O. This is significantly higher than that of the first generation LMA, the LMA-ClassicTM, which has a maximum seal pressure of 20 cmH2O, but averages 16-18 cmH2O in actual practice.
Pilot data from 50 insertions of the air-QⓇ at our institution places the device intermediate to the two aforementioned LMAs with regard to seal pressure, with a mean seal pressure of 23 (12-30) cmH2O.
Specific Aims:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who are 18 years or greater may be included if they presenting for any elective surgery or procedure to take place in any anesthetic location and require placement of a LMA for their surgery or procedure.
排除标准
- •non-English speaking
- •are a minor
- •are a prisoner
- •have impaired decision-making capacity or any condition for which the primary anesthesia team deems intubation with a tracheal tube to be necessary
结局指标
主要结局
Airway Seal Pressure
时间窗: Intraoperative (day 1)
The airway seal pressure will then be assessed by closing the APL valve on the anesthesia machine with a fresh gas flow of 5 liters/minute until an audible leak is observed.
次要结局
- Glottic View(Intraoperative (day 1))
- Grossly Visible Blood or Bile on LMA(Upon LMA removal)
- Airway Pathology(Postoperative Day Two)