A Comparison of Two Supraglottic Devices, the VBM Intubating Laryngeal Tube and I-Gel
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Time in seconds required for placement of supraglottic device
研究概览
简要总结
A study comparing two second generation supraglottic Airway devices, the VBM intubating laryngeal tube and the I-Gel.
详细描述
This is a study comparing the use of a newer generation laryngeal mask to the 2nd generation widely used at present. The company responsible for the manufacture of this product is VBM Medizintechnik GmBH, Germany. The recent difficult airway society guidelines recommend the use of these newer generation devices and this has been the incentive to conduct this project. These newer generation supraglottic devices have an additional feature which is an extension of the mask with a balloon that sits in the oesophagus. The trial is investigating ease of placement of these devices, ventilatory pressures, leak pressure and ease of intubation through the VBM device compared to I-Gel. The position of the supraglottic device on insertion and the position of the endotracheal tube will be confirmed with a fibrescope. A follow up will take place on the same day and after 24 hours for symptoms of a sore throat postoperatively.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Any patient between the age of 18 - 70
- •Any patient having the capacity to consent
- •Any patient requiring general anaesthesia but not endotracheal intubation immediately after induction of anaesthesia.
排除标准
- •Patient refusal
- •Patients involved in another research project
- •Patients who require endotracheal intubation immediately after induction of anaesthesia
- •Patients who are systemically unwell/unstable
- •Patients at risk of aspiration
研究组 & 干预措施
VBM Intubating Laryngeal Tube
Device: VBM Intubating Laryngeal Tube Intervention: VBM Intubating Laryngeal Tube insertion, seal pressure, endotracheal intubation
干预措施: VBM Intubating Laryngeal Tube (Device)
I-Gel
Device: I-Gel Intervention: I-Gel insertion, seal pressure, endotracheal intubation
干预措施: I-Gel (Device)
结局指标
主要结局
Time in seconds required for placement of supraglottic device
时间窗: Through study completion, an average of 30 minutes
Time from device first enters mouth and appearance of end-tidal CO2
次要结局
- Seal pressure measured in cmH2O(Through study completion, an average of 30 minutes)
- Successful endotracheal intubation through the supraglottic airway, end tidal carbon dioxide monitoring in kilopascals(Through study completion, an average of 30minutes)