Point of Care Ultrasound for Evaluation of Suspected Appendicitis in the Emergency
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 262
- 试验地点
- 1
- 主要终点
- Diagnostic Accuracy of Point-of-care Ultrasound for Suspected Appendicitis
研究概览
简要总结
The primary purpose of this study is to determine the accuracy of ultrasound (US) in diagnosing appendicitis in emergency department (ED) 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 appendicitis on the patient length of stay in the emergency department, the diagnostic utility of specific ultrasound findings in the diagnosis of appendicitis, the role of body mass index (BMI) in the utility of ultrasound for appendicitis and relation of ultrasound findings to the Alvarado score. 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:
Increasing concerns have been raised over the past several years regarding the degree of radiation exposure in patients being evaluated for abdominal complaints. A deepening body of literature supports the use of ultrasound for the evaluation of appendicitis. In particular, ultrasound is being promoted as first line testing in the evaluation of appendicitis in pediatric populations and adults with BMI < 25. This approach reduces the risks related to radiation exposure and IV contrast dye. Unfortunately, in many practice settings, the availability of radiology-based sonographers is limited and there can be significant delays in obtaining ultrasound images. For these reasons, many ED physicians (EP) have begun to perform bedside ultrasound to evaluate for appendicitis.
Studies have demonstrated a wide range in the accuracy of ultrasound for appendicitis. Sensitivities and specificities vary and no standardized diagnostic criterion exist. Additionally, little has been published directly studying EP point of care ultrasound in the evaluation for acute appendicitis. One study has shown that EP-performed ultrasounds had a relatively low sensitivity, but a high specificity. However, this study was performed by a wide range of users with varying skill levels and older ultrasound machines. The surgical literature suggests that the ability of the clinician to integrate the history, the physical exam and the ultrasound findings in real time improves the diagnostic accuracy of ultrasound for appendicitis.
Currently there are 4 physicians on staff in the ED who are fellowship trained in point of care emergency ultrasound, fully credentialed and are already performing ED based evaluations for appendicitis on a limited basis. The current standard of care is a point of care ultrasound as first-line imaging for patients with suspected appendicitis when a credentialed EP is available to perform the scan. We intend to evaluate the performance of EP-performed point of care ultrasound in the diagnosis of acute appendicitis in ED patients. This study would primarily investigate the accuracy of ultrasound as compared to the criterion standard of either abdominal CT results or surgical pathology report.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •RLQ pain with clinical suspicion for acute appendicitis
排除标准
- •History of appendectomy
- •Imaging prior to ED ultrasound performed to evaluate the RLQ
- •Patients who are decisionally impaired or cannot provide consent
结局指标
主要结局
Diagnostic Accuracy of Point-of-care Ultrasound for Suspected Appendicitis
时间窗: 3 years
The performance of point-of-care ultrasound for appendicitis 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, discharge diagnosis or phone follow up at 2 weeks 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 appendicitis), 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, likelihood ratios, positive predictive value (PPV), negative predictive value (NPV) and accuracy of point-of-care ultrasound for the diagnosis of appendicitis.
次要结局
- Appendicolith(3 years)
- Inter-rater Agreement(3 years)
- Appendiceal Dilation(3 years)
- Dilated Loops of Bowel in RLQ(3 years)
- Appendiceal Hyperemia(3 years)
- Comparison to Alvarado Score(3 years)
- Intraabdominal Free Fluid(3 years)
- Appendiceal Wall Thickening(3 years)
- Patient Length of Stay/Time to Disposition(3 years)
- Body Mass Index(3 years)
研究者
Brent Becker
Emergency Physician - Wellspan Health York Hospital
WellSpan Health