Comparison of LMA-Fastrach and I-gel for Blind Tracheal Intubation.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 160
- 试验地点
- 2
- 主要终点
- First attempt success rate of tracheal intubation.
研究概览
简要总结
The investigators aim to compare two different types of supraglottic devices for tracheal intubation in patients undergoing elective surgery under general anesthesia.
Our hypothesis is that the use of the I-gel supraglottic airway will result in a higher first attempt success rate of blind tracheal intubation.
详细描述
Supraglottic airway devices such as LMA-Fastrach and I-gel provide patent airways during general anesthesia.
The LMA-Fastrach is designed to provide a conduit for blind or fiberoptically guided tracheal intubations. However, the success rate of tracheal intubation on the first attempt through this device varies between 50 and 87%.
The I-gel is a newer device for airway management which, with its wide bore, allows direct passage of a tracheal tube. Recent studies suggest that the I-gel is easy to insert and that limited experience is needed before a high success insertion rate is obtained.
In this prospective and randomized study, we will evaluate the performance of both devices for tracheal intubation in patients undergoing elective surgery under general anesthesia.
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
- None
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
- •Age 18 and older
- •ASA physical status 1-3
- •Patients undergoing elective surgery under general anesthesia, requiring endotracheal intubation
排除标准
- •ASA physical status 4-5
- •Contraindications to muscle relaxation
- •Anticipated or known difficult intubation or ventilation
- •Patients with limited mouth opening (less than 2 cm)
- •Patients at increased risk of aspiration, or having an history of symptomatic gastroesophageal reflux or hiatal hernia.
研究组 & 干预措施
LMA-Fastrach
- Induction of general anesthesia with 1,5-2,5 mg/kg propofol and 1-3 mcg/kg fentanyl and neuromuscular relaxation with 0,6 mg/kg of rocuronium.
- Direct laryngoscopy, evaluation of laryngeal view grade according to Cormack-Lehane classification
- Insertion of LMA-Fastrach (sizes 3,4 or 5), establishment of ventilation
- Evaluation of glottic view through LMA-Fastrach using fibrescope (one out of ten patients)
- Tracheal intubation through the LMA-Fastrach
- With the endotracheal tube in place, the anaesthesiologist will proceed to the removal of supraglottic device
干预措施: Tracheal intubation (Procedure)
I-gel
- Induction of general anesthesia with 1,5-2,5 mg/kg propofol and 1-3 mcg/kg fentanyl and neuromuscular relaxation with 0,6 mg/kg of rocuronium.
- Direct laryngoscopy, evaluation of laryngeal view grade according to Cormack-Lehane classification
- Insertion of I-gel (sizes 3,4 or 5), establishment of ventilation
- Evaluation of glottic view through I-gel using fibrescope (one out of ten patients)
- Tracheal intubation through the I-gel
- With the endotracheal tube in place, the anaesthesiologist will proceed to the removal of supraglottic device
干预措施: Tracheal intubation (Procedure)
结局指标
主要结局
First attempt success rate of tracheal intubation.
时间窗: After successful insertion of tracheal tube
次要结局
- Time needed for successful insertion of a supraglottic device.(After insertion)
- First and total attempt success rate of supraglottic device insertion.(After insertion)
- Total time and number of attempts needed to obtain successful tracheal intubation.(After tracheal intubation)
- Fiberoptic view following the supraglottic device insertion.(After insertion of the device)