Evaluation of Three Different Techniques for Tracheal Intubation Via Supraglottic Airway Devices: A Comparative Randomised Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Success rate of intubation at first attempt
研究概览
简要总结
This study compares three different supraglottic airway devices used as a conduit for tracheal intubation in order το determine which one achieves the highest success rate of first attempt intubation
详细描述
Prospective, randomized, comparative, clinical, controlled study, that is approved by the Ethics Commitee of the University of Patras (10.12.2019) and takes part in the University Hospital of Patras. Depending on the supraglottic airway device (SGA)/ laryngeal mask airway (LMA) used to achieve intubation (Fastrach, I-gel, Protector), partcipants will be randomly allocated into three groups; Group A, B and C (Fastrach, I-gel, Protector respectively).
In the preoperative setting, a complete preanesthetic evaluation will be performed, including a detailed airway assessment (prediction of difficulty in face mask ventilation, insertion of SGA/LMA and intubation).
All patients are scheduled to undergo an elective surgery under general anesthesia. Before induction, all patients will be preoxygenated with FiO2 100% for at least 5 minutes. After induction, using rocuronium 0.6mg/kg to facilitate neuromuscular blockade, face mask ventilation follows.
- Group A- Fastrach: The intubating laryngeal mask airway (Fastrach) will be placed to the patients of this group. After the mask is correctly placed and patients are adequately ventilated, they will be intubated through the mask using its own endotracheal tube according to the blind technique insertion.
- Group B- I-gel: The supraglottic airway device (I-gel) will be placed to the patients of this group. After the mask is correctly placed and patients are adequately ventilated, they will be intubated through the mask using a fiberoptic bronchoscope to guide endotracheal tube's placement.
- Group C- Protector: The supraglottic airway device (Protector) will be placed to the patients of this group. After the mask is correctly placed and patients are adequately ventilated, they will be intubated through the mask using a fiberoptic bronchoscope to guide endotracheal tube's placement.
In all groups (A, B, C) up to 3 attempts of SGA/LMA placement and up to 3 attempts of intubation are allowed to be made.
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
- 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
- •Patients (age ≥ 18 yrs) scheduled for an elective surgery under general anesthesia
- •Written informed consent to participate in the trial
排除标准
- •Age < 18 yrs
- •Non- elective (urgent/ emergency) procedures or multi-trauma patients
- •Obstetric population
- •Surgery performed under regional anesthesia
- •Contraindication to LMA insertion
- •Predicted difficulty in LMA insertion (at least one out of four "RODS" criteria)
- •Contraindication to the use of neuromuscular blockade or situations that require spontaneous breathing
- •Indication for awake intubation or surgical airway
- •Patients' involvement in another clinical trial
结局指标
主要结局
Success rate of intubation at first attempt
时间窗: Up to study completion, an average of 2 years
Recording of successful tracheal intubation at first attempt (yes/no) and evaluation of the success rate at first attempt
次要结局
- Time required for tracheal intubation(Up to study completion, an average of 2 years)
- Time required for successful supraglottic airway device/ laryngeal mask placement(Up to study completion, an average of 2 years)
研究者
Maria Spyraki
Principal Investigator
University Hospital of Patras