Improvement of Diagnostic Approach Using PoCUS for Right Upper Quadrant Abdominal Pain Management in the Emergency Department: A Prospective Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 66
- 试验地点
- 2
- 主要终点
- Change in diagnostic approach before and after the use of point of care ultrasound
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, abdominal pain accounts for 7% to 10% of emergency department consultations, while the mean reported prevalence of abdominal pain in family physician consultations is 2.8%. PoCUS can be used in a variety of ways during abdominal physical examinations, and most scientific societies encourage its use to address a specific clinical question rather than provide a diagnosis, which is usually confirmed by comprehensive ultrasound in radiology. The integration of PoCUS into clinical examination raises the issue of PoCUS accuracy to improve the diagnostic approach as opposed to PoCUS diagnostic accuracy itself. Considering the wide range of differential diagnoses associated with right upper quadrant pain, this multicenter prospective study protocol aims to evaluate the improvement of the diagnostic approach using PoCUS in patients presenting at an emergency department with right upper quadrant abdominal pain. In light of the final diagnosis at 1-month follow-up, two members of an adjudication committee will blindly choose between two case report forms: one filled in before PoCUS and the other completed after the use of PoCUS by the investigator in charge of a patient suffering from right upper quadrant abdominal pain. The hypothesis that PoCUS enhances diagnostic approaches by 18% will be reached if 74.8% of the better diagnostic approaches are in favor of the case report form filled in after PoCUS.
详细描述
- Background Many medical specialties and paramedical fields are increasingly using point-of-care ultrasound (PoCUS). PoCUS is a pillar of clinical evaluation along with inspection, palpation, percussion, and auscultation, and it has become essential in daily clinical practice, as it enhances 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 the learning of core concepts and enhance students' understanding of physical examinations. The integration of PoCUS into clinical examination raises the issue of PoCUS accuracy to improve the diagnostic approach as opposed to the issue of PoCUS diagnostic accuracy itself.
In daily practice, abdominal pain accounts for 7% to 10% of emergency department consultations, while the mean reported prevalence of abdominal pain in family physician consultations is 2.8% according to a recent systematic review. PoCUS can be used in many ways during abdominal physical examinations, and most scientific societies encourage its use to address a specific clinical question rather than to provide a diagnosis, which is usually confirmed by a comprehensive ultrasound in radiology. For this reason, it is necessary to evaluate PoCUS accuracy in order to improve the diagnostic approach.
Among abdominal pain, right upper quadrant pain evokes a large differential diagnosis. PoCUS is a valuable tool to investigate right upper quadrant abdominal pain, as it can orientate the investigator toward the presence of free fluid, lung involvement, aortic aneurysm, gallbladder involvement, hydronephrosis, or small bowel obstruction.
The primary objective of this study is to evaluate the contribution of PoCUS to the clinical examination of patients presenting in an emergency department with right upper quadrant abdominal pain. The secondary outcomes are the influence of PoCUS on the choice and number of additional complementary diagnostic examinations, its influence on the physicians' coefficient of certainty in terms of the diagnostic approach, differential diagnosis, and initiated treatment, and finally, the influence of patients' characteristics or PoCUS findings on the primary outcome. 2. Method
- Trial design This study is an interventional multicenter prospective study assessing the improvement of the diagnostic approach using PoCUS as part of the clinical examination for patients presenting in an emergency department with right upper quadrant 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
盲法说明
In light of final diagnosis, an adjudication committee will evaluate the best diagnostic approach, blind to intervention for each patient.
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
- •Right upper quadrant abdominal pain < 11 days
- •Signed informed consent
排除标准
- •Any reason that prevents ultrasound use
- •Pregnancy
- •Palliative care status or poor prognosis at 1-month follow-up
- •Impossibility of 1-month follow-up
- •Insufficient knowledge of French or Dutch to understand the informed consent
- •Secondary exclusion criteria:
- •Lost to follow-up
- •Previously unknown pregnancy diagnosed during the emergency department consultation
- •Emergency of care deemed incompatible with the study process by the investigator
结局指标
主要结局
Change in diagnostic approach before and after the use of point of care ultrasound
时间窗: through study completion, at an average of 7 months
Rate of diagnostic approach considered improved after intervention by the adjudication committee Two independent members of an adjudication committee will evaluate two diagnostic approaches (before and after PoCUS) reported in the case report forms (CRFs) of patients suffering from right upper quadrant abdominal pain in an emergency setting while considering the final diagnosis determined at 1-month follow-up. As the adjudication committee members are blind to the intervention, they do not know which diagnostic approach reported in the CRFs is performed before or after PoCUS. For each patient file, the adjudication committee must choose the better diagnostic approach or state that the diagnostic approach is unchanged.
次要结局
- PoCUS influence on the choice of complementary examination(s)(through study completion, at an average of 7 months)
- Influence of PoCUS findings (hydronephrosis, gallstones, free fluid, aortic aneurysm, small bowel obstruction, pleural effusion, lung interstitial syndrome) on the primary outcome(through study completion, at an average of 7 months)
- PoCUS usefulness qualitatively evaluated by the investigator as:not useful, slightly useful, moderately useful, useful, very useful(through study completion, at an average of 7 months)
- Influence of patients' characteristics (BMI, echogenicity, triage score, pain scale, final diagnosis) on the primary outcome(through study completion, at an average of 7 months)
- Comparison of the absolute number of complementary examination planned before and after intervention(through study completion, at an average of 7 months)
- PoCUS influence on the physicians' coefficient of certainty regarding the initiated treatment(through study completion, at an average of 7 months)
- PoCUS influence on the physicians' coefficient of certainty regarding the diagnostic approach(through study completion, at an average of 7 months)
- PoCUS influence on the physicians' coefficient of certainty regarding the differential diagnosis(through study completion, at an average of 7 months)