Impact of Emergency Physician-Performed Ultrasound for the Evaluation of Patients With Acute Abdominal Pain, Prospective Randomized Dual Centre Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 256
- 试验地点
- 3
- 主要终点
- Exact diagnostic rate
研究概览
简要总结
Non-traumatic abdominal pain is one of the most frequent complaints in Emergency Medicine. Point-of-Care Ultrasound (POCUS) has good performance in these situations. It is performed at the patient's bedside with immediate results. It has been demonstrated that a clinician-performed ultrasound was able to increase the diagnosis accuracy in patients with acute abdominal pain. However, the level of evidence of its diagnostic efficacy remains controversial in particular in Europe.
The principal investigators thus aimed to investigate the efficacy of early POCUS on diagnostic accuracy in the context of of non-traumatic abdominal pain by a randomized control study conducted in two emergency departments (ED). Secondary objectives will be comparison between the two groups for time spent in the ED before diagnosis and disposition (discharged home or hospitalization), prescription of complementary examinations and in particular, radiologic exams.
详细描述
Non-traumatic abdominal pain is one of the most frequent complaints in Emergency Medicine. Point-of-Care Ultrasound (POCUS) has good performance in these situations. It is performed at the patient's bedside with immediate results. It has been demonstrated that a clinician-performed ultrasound was able to increase the diagnosis accuracy in patients with acute abdominal pain.
The principal investigators thus aimed to investigate the efficacy of early POCUS on diagnostic accuracy in the context of of non-traumatic abdominal pain by a randomized control study conducted in two ED. Secondary objectives will be comparison between the two groups for time spent in the ED before diagnosis and disposition (discharged home or hospitalization), prescription of complementary examinations and in particular, radiologic exams.
It will be a randomized, controlled, open and interventional study. In the control group, the diagnosis will be established after clinical examination and reception of biological analysis results. In the interventional group, a POCUS performed in the ED by a local investigator will be added and the diagnosis will be established after clinical exam, biological analysis reception and POCUS. POCUS will only be performed by physicians who have completed a validated training program.
Furthermore, before study initiation, refresh sessions focused on acquisition techniques and pathological findings will be organized in the two participating ED. Such refresher courses were efficient to increase the overall confidence of operators
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
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
- •Patients older than 18 years
- •Admitted for acute abdominal pain lasting for less than 5 days
- •Availability in the ED at that time of an Emergency Physician trained in POCUS
- •Patient able to understand the protocol and having given oral informed consent to participate in the study or included under the emergency inclusion procedure
排除标准
- •Documented end-of-life with a do-not-resuscitate order
- •Immediate need for management for hemodynamic stabilization
- •Patient sent to the ED by an out-of-hospital practitioner
- •Pregnant and breast-feeding women
- •No social security
- •Under guardianship, curatorship or deprived of liberty.
- •Do not understand French
结局指标
主要结局
Exact diagnostic rate
时间窗: The reference diagnosis will be determined by an adjudication committee on the basis of an exhaustive analysis of the patient's file at Day 28
Comparison of the rate of exact diagnostic after clinical exam and biological results with point-of-care ultrasound (interventional arm) or without (control arm) according to the adjudication committee diagnostic (reference diagnosis).
次要结局
未报告次要终点