Prospective Non-interventional Evaluation of Intubation and Intensive Care Use of the New aScope™ 4 Broncho and aView
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Ambu A/S
- 入组人数
- 176
- 试验地点
- 1
- 主要终点
- User Preference of Scope
研究概览
简要总结
This study is designed as a prospective observational, non-controlled, non-interventional study.
The aim of this study is to obtain a broad user perspective of the aScope™ 4 Broncho, focusing on the device functionalities within regular clinical practice and therapeutic use of flexible bronchoscopes in the OR and ICU.
The study will include a minimum of 100 adult patients admitted to the operating room (OR) or Intensive Care Unit (ICU) undergoing at least one bronchoscopy procedure. The inclusion will stop when 100 fully evaluable patients or a maximum of 150 patients have been enrolled.
The involved sites will include patients during a five months' period, from September 2017 to January 2018.
详细描述
Refer to brief description
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 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient's ≥18 years
- •Clinical indication and eligible for an airway procedure involving a bronchoscopy procedure, as judged by the Investigator
- •Patients being admitted in the OR or ICU at the investigational site
排除标准
- 未提供
结局指标
主要结局
User Preference of Scope
时间窗: Data on patients from September 2017 to January 2018, investigators memory assessed immediately following use of the aSCope 4TM Broncho at each patient visit
This non-interventional study compared the clinical performance of the Ambu aScope 4TM Bron-cho with the standard bronchoscope (reusable or single-use) normally used at each of the study centers based on the investigators memory of the standard bronchoscope.
次要结局
未报告次要终点