Prospective Feasibility Study of Point-of-care Ultrasound in Suspected Aortic Dissection
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- Successful completion of FESDAU protocol.
研究概览
简要总结
Aortic dissection is an uncommon and serious pathology. Its diagnosis is difficult because of the varied and silent clinical presentations. The development of ultrasound in emergency medicine is an asset in certain pathologies. The aim of this study is therefore to study the feasibility of a protocol integrating clinical ultrasound in the suspicion of acute aortic dissection in the hospital setting. This study is a single-center prospective interventional study. In which the investigators perform ultrasound in patients with suspected acute aortic dissection in the emergency department. If the protocol is feasible and if it allows a saving of time in the diagnosis or an increase in diagnoses, the investigators will be able to evoke a profitability to the systematic realization of this examination.
详细描述
H0: patient selection and inclusion:
- Presentation of the study
- Delivery of the information note / no objection to the patient if he/she is in a state to consent
- Emergency procedure:
In accordance with article L-1122-1-3 of the public health code, patients may be included in the study at the initiative of the physician without seeking prior consent. This procedure will be associated with a prior call to the relatives to obtain an oral consent in principle (traced in the patient's medical file), while waiting for the delivery of the information note / no objection to the relatives and then to the patient as soon as his condition allows it.
H1: inclusion interview then :
Medical interrogation (retrospective collection if already done / but additional requests if missing data).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 95 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Men and women aged 18-95 years included
- •Non-opposition of the subject to participate in the study
- •All patients admitted to the emergency department of the Besançon University Hospital With chest, abdominal, back, lumbar pain, or acute headache
- •AORTA score ≥ 1
- •Clinical suspicion of AD by the emergency physician
排除标准
- •Legal incapacity or limited legal capacity
- •Subject unlikely to cooperate with the study and/or poor cooperation anticipated by the investigator
- •Subject without health insurance
- •Pregnant woman
- •ECG showing acute coronary syndrome and/or ventricular rhythm disturbances
- •Traumatic context, or traumatic cause of pain
- •Chronic / subacute dissection (patient with incidental discovery of aortic dissection (city assessment) and then referred to the emergency room).
- •Patient refusal to participate in the study
研究组 & 干预措施
ultrasound arm
every patient will be examine with ultrasound
干预措施: ultrasound (Other)
结局指标
主要结局
Successful completion of FESDAU protocol.
时间窗: 15 minutes
The statistical analysis on the primary endpoint will be a percentage of success in completing the FESDAU protocol among all eligible individuals.
次要结局
- time to diagnosis(24 hours)
- Time to perform the ultrasound(60 minutes)
- Ultrasound slices with a suggestive sign(60 minutes)