Clinical Performance of the Baska MaskⓇ, the I-GelⓇ and the Self-Pressurized Air-QⓇ i
试验速览
- 阶段
- 不适用
- 入组人数
- 78
- 试验地点
- 1
- 主要终点
- insertion time
研究概览
简要总结
The Baska mask (proact Medical Ltd, Northants, UK) is the latest addition to an era of supraglottic airway devices in clinical use. It is made of medical grade silicone; it has many advantages in its constructions over other LMA, a cuff less membranous bowl in which the saliva secretion collected. An inbuilt "tab" that allows to extend its angulation for straightforward negotiation of the oropharyngeal curve during placement
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Inclusion criteria
- •Adult patients from 18 to 60 years of age.
- •American Society of Anesthesiologists (ASA) physical status I and II
- •Both genders
- •Patients scheduled for elective surgeries lasting less than 2 hours under general anesthesia on spontaneous ventilation.
- •El Ganzouri index Score ≥ 4
- •Patients with BMI < 35 kg/m2
排除标准
- •The patients who will be refusal or inability to give informed consent,
- •ASA class III or IV
- •El Ganzouri index Score < 4,
- •Oropharyngeal pathology making a proper SAD fit unlikely as weak dentation, neck pathology
- •Respiratory illness including upper respiratory infection or pneumonia within the six weeks preceding surgery
- •Risk for gastric aspiration (e.g., hiatus hernia, gastro-oesophageal reflux disease or non-fasting status), expected duration of surgery longer than 2 h
- •Contraindication to SGA use including morbid obesity (body mass index 35 kg m-1, history of obstructive sleep apnea)
- •Any condition for which the primary anesthesia team deemed intubation with a tracheal tube to be necessary.
研究组 & 干预措施
group II
will be inserted Single use supraglottic airway ( I-gel® ) (Intersurgical Ltd, Wokingham, Berkshire, UK)
干预措施: airway divice (Device)
group I
will be inserted Single use supraglottic airway ( Baska mask® (proact Medical Ltd, Northants, UK)
干预措施: airway divice (Device)
group III (SP Air-Q) (n = 26)
will be inserted Single use supraglottic airway (self-pressurized Air-Q intubating laryngeal airway (Air-Q SP®)) (Mercury Medical, Clearwater, FL, USA)
干预措施: airway divice (Device)
结局指标
主要结局
insertion time
时间窗: 1 hour
To determine the time taken for insertion of the device. (It will be calculated from the time of the mask will be taken away from the patient's face till the moment of the appearance of square wave capnography upstroke with the presence of sufficient ventilation) (second )
次要结局
- Ease of device insertion(1 hours)
- Oropharyngeal leak pressures(1 hours)
研究者
Amr Samir Wahdan
Principal Investigator
Cairo University