Prospective Non-interventional Evaluation of Insertion and Sealing Performance of AuraOnce Disposable Laryngeal Mask US Version
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Ambu A/S
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Number of Participants With Leakage Observed During Procedure
研究概览
简要总结
This study is designed as a single-center, prospective observational, non-controlled, non-interventional study with an investigation period lasting for one day (during one bronchoscopy procedure). The study will take place in Denmark.
The study will include minimum 15 and maximum 20 adult patients planned for a diagnostic flexible bronchoscopy procedure in general anaesthesia using a laryngeal mask. The involved site will include subjects during a one month period, October 2019.
The intention is to perform a quality assessment of the AuraOnce. Subjects will not be asked to participate in this study as it is a quality study where the AuraOnce is used within its intended use and according to normal clinical procedure.
详细描述
This study is designed as a single-center, prospective observational, non-controlled, non-interventional study with an investigation period lasting for one day (during one bronchoscopy procedure). The study will take place in Denmark.
The study will include minimum 15 and maximum 20 adult patients planned for a diagnostic flexible bronchoscopy procedure in general anaesthesia using a laryngeal mask. The involved site will include subjects during a one month period, October 2019.
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
- 否
入选标准
- •Subjects > 18 years
- •Subjects planned for diagnostic flexible bronchoscopy procedure in general anesthesia using a laryngeal mask.
排除标准
- •Subjects where use of AuraOnce cannot be clinically justified
结局指标
主要结局
Number of Participants With Leakage Observed During Procedure
时间窗: During procedure, less than 1 hour
Is leakage observed (yes/no) if yes, insert signs of leakage
次要结局
- Number of Participants Where Tip of the Mask is Folded(During procedure, less than one hour)
- Investigator Evaluation of Ease of Insertion on a 5-point Scale (Very Difficult (=1) to Very Easy (=5))(During procedure, less than 1 hour)
- Investigator Evaluation of Ease of Obtaining Seal on a 5-point Scale (Very Difficult (=1) to Very Easy (=5))(During procedure, less than 1 hour)
- Investigator Evaluation of Overall Performance on a 5-point Scale (Very Bad (=1) to Excellent (=5))(During procedure, less than 1 hour)
- Number of Participants With Correct Placement of Mask(During procedure, less than 1 hour)