NCT05964075已完成不适用
A Randomized Controlled Trial to Assess the Safety and Efficiency of a Self-Contained Sampling Device /disposable Bronchoscope System Versus Usual SampLing Procedure.
Chelsea and Westminster NHS Foundation Trust1 个研究点 分布在 1 个国家目标入组 207 人开始时间: 2022年1月14日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 207
- 试验地点
- 1
- 主要终点
- Comparison of two sampling pots
研究概览
简要总结
Prospective, multi-centre, open labelled, 1:1randomized controlled study.
详细描述
- Patients admitted to ICU with acute respiratory failure, requiring mechanical ventilation with, suspected or confirmed COVID-19.
- Patients admitted to ICU with acute respiratory failure due to a condition other than COVID-19, requiring mechanical ventilation.
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
- •(All are required)
- •Clinicians experienced in performing bronchoscopies (i.e. bronchoscopists should have performed a minimum 5 bronchoscopies in mechanically ventilated patients and a minimum of 5 bronchoscopies in a simulated or practice setting).
- •Clinicians who have undergone the online product-training module for the use of the Ambu Bronchosampler, with self-certification documented.
- •Clinicians who have simulated the online product training module using an Ambu Bronchosampler and Ambu Ascope4 a minimum of 5 times in a practice setting and have self-certified.
- •Patients ≥ 18 years old
- •Patients on mechanical ventilation with Acute respiratory failure for >4h
- •Patients eligible for a clinically indicated bronchoscopy with fluid sampling. Patient information has been explained and verbal or written consent has been obtained
排除标准
- •Investigators
- •Investigators who have not completed product training in aScope BronchoSampler by online and hands-on from Ambu product specialists or an experienced user from the site.
- •Investigators with experience in < 5 self-verified simulated fluid sampling procedures using the Ambu BronchoSampler 4.8.2 Population
- •Clinician concern regarding safety of bronchoscopy
- •Involved study personal not available to perform the procedure and enroll the patient
结局指标
主要结局
Comparison of two sampling pots
时间窗: 1month
Can the Ambu Bronchosampler improve safety versus usual standard care by reducing the risk of spillage or disconnection of the sampling system during a procedure?
次要结局
未报告次要终点
研究者
研究点 (1)
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