NCT05304494撤回不适用
Sentinel - Triaging Acute Breathlessness Using Multi-Modal Biomarkers
Sanome0 个研究点开始时间: 2022年3月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 主要终点
- Physician assessed severity of breathlessness
研究概览
简要总结
The Sentinel-001 study aims to identify a combination of biomarkers suitable for triage of breathlessness.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18-90 years.
- •Has experienced episode of breathlessness during the past 12 months triggering interaction with a health care professional. Self-reported breathlessness using any of the following words to describe symptoms will qualify as a presentation of breathlessness regardless of aetiology or severity of symptoms: shortness of breath, tight chest, trouble breathing, breathlessness, dyspnoeic, breathless, asthmatic, suffocating, wheezing, fighting for breath or any equivalent word. Breathlessness does not have to be the primary presenting symptom.
- •Deemed clinically sufficiently stable to participate according to health care practitioner.
排除标准
- •Inability to understand written local language at a year 5 level.
- •Not being confident in use of digital technology (smartphone and/or tablet). This will become evident through an inability to use the system.
- •Inability to enter required study sample data due to diminished consciousness and/or physical or mental capacity regardless of whether this is associated with the breathlessness event.
- •Received an investigational medical product in the context of a Clinical Trial during the 28 days prior to first probe administration.
结局指标
主要结局
Physician assessed severity of breathlessness
时间窗: 1 day (One-time assessment during a participant reported episode of breathlessness)
Breathlessness requiring admission or supplementary oxygen, breathlessness requiring intervention \< 24 hours, Breathlessness requiring medical intervention within 24 hours without meeting the criteria for severe breathlessness, Breathlessness not requiring any medical intervention within 24 hours other than a dose change in the individuals pre-established pharmacological treatment plan
次要结局
未报告次要终点
研究者
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