Analysis of 150 Consecutive Uses of the Ambu® AuraGain Supraglottic Airway by One Anaesthetist in Ambulatory Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Evaluate the number of attempts to insert the Ambu® AuraGainTM supraglottic airway
研究概览
简要总结
The study was designed to evaluate the success rate, time of insertion, sealing efficacy and security of the Ambu® AuraGain in patients undergoing ambulatory surgery by one anesthetist
详细描述
Supraglottic devices (SGD), in all their different forms, have become an authentic innovation in airway management especially in day surgery. The Ambu® AuraGainTM (Ambu A/S, Ballerup, Denmark) is a new single-use, anatomically curved supraglottic airway with an integrated gastric access port designed to provide functional separation of the respiratory and digestive tracts allowing the exit of gastric contents and the passage of a gastric tube to manage gastric contents.
Its characteristics in the design, composition by a smooth and atraumatic material, the presence of the gastric drainage access, with potential improved patient safety and its characteristic of being disposable, suggests a significant expansion of its use in the coming years.
The series in the literature reporting performance or safety of use of the Ambu® AuraGainTM come from studies on selected cases and in certain surgical procedures. However, there are limited studies that have evaluated the efficacy of the device in routine clinical practice in patients intervened in ambulatory surgery and performed by a single investigator.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients undergoing surgery procedures in ambulatory surgery usually performed with supraglottic devices.
- •ASA physical status I-III patients
- •Age 18-no limit
排除标准
- •Patients with known difficult airway
- •Patients with increased risk of aspiration
- •Patient refusal to participate in the study
结局指标
主要结局
Evaluate the number of attempts to insert the Ambu® AuraGainTM supraglottic airway
时间窗: The number of insertion attempts will be collected after anesthesia induction
Insertion attempts (in numbers) From picking up the Ambu® AuraGainTM supraglottic airway until the mask is placed into the patient mouth. (in numbers)
Evaluate the time to insert the Ambu® AuraGainTM supraglottic airway
时间窗: The insertion time will be collected after anesthesia induction after administration of propofol
The time from picking up the Ambu® AuraGainTM supraglottic airway until the cuff was inflated. (in seconds)
次要结局
- Heart rate during insertion of the Ambu® AuraGainTM supraglottic airway heart rate(At baseline and every 3 minutes until 6 minutes after insertion of the Ambu® AuraGainTM supraglottic airway])
- BIS data(At baseline and every 3 minutes until 6 minutes after insertion of the Ambu® AuraGainTM supraglottic airway (To evaluate the evolution of BIS values during insertion of the Ambu® AuraGainTM supraglottic airway)
- Oropharyngeal leak pressure of the Ambu® AuraGainTM supraglottic airway.(The Oropharyngeal leak pressure of the Ambu® AuraGainTM supraglottic airway will be collected 10 minutes after the Ambu® AuraGainTM supraglottic airway will be inserted])
- Blood pressure during insertion of the Ambu® AuraGainTM supraglottic airway(At baseline and every 3 minutes until 6 minutes after insertion of the Ambu® AuraGainTM supraglottic airway)
研究者
Matilde Zaballos
Anesthesiologist
Hospital General Universitario Gregorio Marañon