I-gel Versus AuraGain for Bronchoscopic Intubation Through Supraglottic Airway Device - a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Total time for airway management
研究概览
简要总结
This trial compares two different second generation supraglottic airway devices (AuraGain and I-gel) used as a conduit for bronchoscopic tracheal intubation during continuous oxygenation in order tο determine time to successful tracheal intubation and ease of use.
详细描述
A prospective randomized controlled trial in the Department of Anesthesiology, Copenhagen University Hospital Nordsjællands Hospital-Hillerød Denmark. The study is approved by the Ethics Committee, capital region of Denmark. The aim of the study is to compare bronchoscopic tracheal intubation during continuous oxygenation through the AuraGain and I-gel supraglottic airway device. One hundred patients will be randomly allocated into two groups, group A (AuraGain) and group B (I-gel). Study outcomes are time to tracheal intubation confirmed by capnography as well as anesthesiologists reports of ease of use. Twenty-five anesthesiologists participates in this study, and are allocated four patient each. In random order, each physician will perform two bronchoscopic tracheal intubations with each SGA.
In the preoperative setting, a complete anesthetic evaluation will be performed, including a detailed airway assessment determining predictors for difficulties of face mask ventilation, insertion of SGA and tracheal intubation. Participants are scheduled to undergo elective surgery under general anesthesia. Before induction, all patients will be preoxygenated with 100% oxygen. After induction, rocuronium 0.6mg/kg will be used to facilitate neuromuscular blockade. Sufficient face mask ventilation will be performed before intervention.
Group A: AuraGain:
Time is measured from when the anesthesiologist reaches for the AuraGain LMA until the mask is placed and adequate ventilation is confirmed by capnography. The AuraGain LMA will be used as conduit for bronchoscopic intubation during continuous oxygenation, and time is measured until placement of the tracheal tube verified by capnography.
Group B: I-gel:
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
- Double (Participant, Outcomes Assessor)
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 scheduled for a non-acute ENT, gynaecological, gastrointestinal or orthopaedic surgical procedure for which general anaesthesia including oral intubation with an endotracheal tube will be provided
排除标准
- •Age<18 years
- •Inter-incisional distance <30mm
- •Pregnant and BMI>40kg/m2
- •ASA physical status classification system grade >3
- •Earlier laryngeal or pharyngeal surgery
- •Increased risk of aspiration (e.g. nasogastric tube inserted, planned Rapid Sequence Induction)
- •Informed consent cannot be obtained
- •Patients with stridor
- •Patients with hypoxemia defines by saturation <90 without oxygen at arrival to the operating room
- •Use of oxygen supply at home
- •Need of one of the following special endotracheal tubes for scheduled surgery: neural integrity monitor (NIM) electromyogram (EMG) tracheal tubes, wire tubes
- •Patients scheduled for any awake approach to secure the airway e.g. awake videolaryngoscopy, awake fiberoptic bronchoscope intubation
结局指标
主要结局
Total time for airway management
时间窗: Up to study completion, an average of 4 months
Total time from reaching the SGA with hands to ended bronchoscopic tracheal intubation confirmed by the end of first curve on capnography
次要结局
- Time to placement of SGA(Up to study completion, an average of 4 months)
- Time to trans-device tracheal intubation(Up to study completion, an average of 4 months)
- Number of attempts needed for correct placement of SGA(Up to study completion, an average of 4 months)
- Number of attempts needed for correct intubation(Up to study completion, an average of 4 months)