PoCUS Impact on the Diagnostic Approach for Thoracic and Abdominal Pain in the ED
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 406
- 主要终点
- Percentage of superior diagnostic approaches post-PoCUS.
研究概览
简要总结
Many medical specialties and paramedical fields are increasingly using point-of-care ultrasound (PoCUS). In daily practice, thoracic and abdominal pain constitute a significant portion of emergency department consultations. PoCUS can be employed in various ways during thoracic and abdominal physical examinations. Most scientific societies advocate for its use to address specific clinical questions rather than to provide a definitive diagnosis.
The integration of PoCUS into clinical examinations raises the question of its effectiveness in improving the diagnostic approach, rather than its diagnostic accuracy alone. Given the broad spectrum of differential diagnoses for thoracic and abdominal pain, this multicenter prospective study protocol aims to evaluate how PoCUS enhances the diagnostic approach for patients presenting with these symptoms in the emergency department.
To assess the contribution of PoCUS, three members of an adjudication committee will blindly choose between two case report forms reporting the planned diagnostic approach for each patient: one completed before PoCUS and the other after its use by the investigator handling the case. The hypothesis that PoCUS improves the diagnostic approach by 60% will be reached if 60% of the improved diagnostic approaches favor the case report form filled out after PoCUS.
详细描述
- Background
Point-of-care ultrasound (PoCUS) is increasingly utilized across various medical and paramedical fields. As a fundamental component of clinical evaluation alongside inspection, palpation, percussion, and auscultation, PoCUS has become indispensable in daily clinical practice enhancing differential diagnosis. In a position statement published in 2015, the American Academy of Emergency Medicine followed by the European Federation of Societies for Ultrasound in Medicine and Biology in 2016 recommended the inclusion of PoCUS in the curricula of medical schools to improve core concepts learning and enhance students' understanding of physical examinations. The integration of PoCUS into clinical practice emphasizes its role in refining the diagnostic approach rather than merely focusing on its diagnostic accuracy.
In daily practice, thoracic pain accounts for about 5% and abdominal pain for 7% to 10% of emergency department consultations. PoCUS can be used in many ways during thoraco-abdominal physical examinations, and most scientific societies encourage its use to address a specific clinical question rather than to provide a diagnosis. For this reason, it is important to focus on the impact of PoCUS on the overall diagnostic approach rather than solely on its diagnostic accuracy. The diagnostic approach includes selecting diagnoses for differential diagnosis, choosing appropriate treatments, and determining necessary complementary examinations, all conducted following the clinical examination.
The primary objective of this study is to evaluate the contribution of PoCUS to the diagnostic approach of patients presenting to the emergency department with thoracic or abdominal pain. Secondary outcomes include the influence of PoCUS on the selection and number of diagnoses in the differential diagnosis, the number of additional treatments or complementary diagnostic examinations, its impact on physicians' confidence in their diagnostic approach, the influence of patient characteristics or PoCUS findings on the primary outcome and evaluate financial aspects. 2. Method
• This study is an interventional multicenter international prospective study evaluating the contribution of PoCUS on the diagnostic approach for patients presenting at the emergency department with thoracic or abdominal pain.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •> 17 years
- •Thoracic or abdominal pain for less than 72 hours
- •Signed informed consent
排除标准
- •Reasons making abdominal ultrasound impossible
- •Discovery of a pregnancy during emergency care
- •Follow-up impossible at one month
结局指标
主要结局
Percentage of superior diagnostic approaches post-PoCUS.
时间窗: From enrollment to the completion of the one-month follow-up
Percentage of superior diagnostic approaches post-PoCUS. For each patient included in the final analysis and based on the final diagnosis determined at the 1-month follow-up, three independent members of an adjudication committee will evaluate the two diagnostic approaches (pre-PoCUS and post-PoCUS) recorded in the case report forms (CRFs). The adjudication committee members will remain blinded to the intervention, ensuring they are unaware of whether the diagnostic approach occurred before or after PoCUS. For each patient, the committee, knowing the final diagnosis, will assess and determine which diagnostic approach is superior or if the two approaches are equivalent.
次要结局
- PoCUS influence on the number of diagnoses in the differential diagnosis, on the number of treatments and on the number of complementary examination(s)(From enrollment to the completion of the one-month follow-up)
- PoCUS influence on the physicians' coefficient of certainty regarding the diagnostic approach(From enrollment to the completion of the one-month follow-up)
- PoCUS influence on the physicians' coefficient of certainty regarding the final diagnosis if this diagnosis is part of the differential diagnosis established bedside(From enrollment to the completion of the one-month follow-up)
- PoCUS usefulness evaluated by the physician in charge(From enrollment to the completion of the one-month follow-up)
- Influence of PoCUS findings on the primary outcome (Positive PoCUS or negative PoCUS)(From enrollment to the completion of the one-month follow-up)
- Impact of the body mass index level on the primary outcome(From enrollment to the completion of the one-month follow-up)
- Influence of PoCUS on financial aspects(From enrollment to the completion of the one-month follow-up)