Point of Care Ultrasound for Suspected Small Bowel Obstruction in the Emergency Department
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 217
- 试验地点
- 3
- 主要终点
- Diagnostic Accuracy of Point-of-care Ultrasound for Small Bowel Obstruction
研究概览
简要总结
The primary purpose of this study is to determine the accuracy of ultrasound in diagnosing small bowel obstruction in emergency department patients, as compared to the criterion standards of computed tomography, operative reports, or discharge diagnosis.
The secondary purposes of the study include evaluation of the effect of ultrasound for small bowel obstruction on the patient length of stay in the emergency department and the diagnostic utility of specific ultrasound findings in the diagnosis of small bowel obstruction. The study will also examine the inter-rater agreement between point-of-care sonographers' interpretation and blinded reviewers' interpretation of the ultrasound images.
详细描述
Background:
An estimated 15% of emergency department (ED) patients admitted to a surgical unit with abdominal pain are ultimately diagnosed with small bowel obstruction (SBO) (1). The work up of patients with possible SBO is directed by the patient history, physical examination and pre-test probability. Relatively insensitive abdominal x-rays (AXR) are commonly ordered as a screening test, but computed tomography (CT) imaging is often necessary to confirm or exclude the diagnosis of SBO. This diagnostic process is time consuming, costly and exposes the patient to ionizing radiation.
Interest in point-of-care (POC) ultrasonography (US) for the evaluation of suspected SBO has increased in recent years. A growing body of literature suggests US is more sensitive and specific compared to AXR in the diagnosis of SBO (1-3). US also confers the benefits of less radiation exposure and more rapid decision-making. CT is generally considered the diagnostic criterion standard for SBO, but effective use of POC US may reduce the need for CT imaging and expedite the care of patients with suspected SBO.
Currently, there are five emergency physicians (EP) on staff in the York Hospital ED who are fellowship trained in POC US. These physicians are fully credentialed and are already performing ED based evaluations for small bowel obstruction. We intend to evaluate the performance of EP-performed POC US in the diagnosis of SBO in ED patients. This study would primarily investigate the accuracy of ultrasound as compared to the criterion standard of abdominal CT results, intraoperative diagnosis, or discharge diagnosis.
Study design:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •18 years of age or greater
- •Abdominal pain with clinical suspicion for small bowel obstruction
排除标准
- •Less than 18 years of age
- •Lack of decision-making capacity or cannot provide consent
- •Pregnancy
- •Prisoners
结局指标
主要结局
Diagnostic Accuracy of Point-of-care Ultrasound for Small Bowel Obstruction
时间窗: 2 years
The performance of point-of-care ultrasound for small bowel obstruction will be evaluated by comparing each ultrasound to the criterion standard of computed tomography (CT) for each enrolled patient. If a CT is not obtained, then operative report/findings or discharge diagnosis will be used as the criterion standard to which the ultrasound will be compared. Using the criterion standard as the definitive diagnosis for each patient (i.e. presence or absence of small bowel obstruction), each ultrasound will be classified as a true positive, true negative, false positive or false negative. This data will be used to calculated the sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) and accuracy of point-of-care ultrasound for the diagnosis of small bowel obstruction.
次要结局
- Incidence/Likelihood Ratios of Specific Sonographic Findings of Small Bowel Obstruction(2 years)
- Patient Length of Stay/Time to Disposition(2 years)
- Inter-rater Agreement(2 years)
研究者
Brent Becker
Emergency Physician - Wellspan Health York Hospital
WellSpan Health