CT Scan Using IV Contrast Alone for Pediatric Appendicitis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Sensitivity, Specificity, PPV, NPV for CT Scan with IV contrast alone
研究概览
简要总结
Computed tomography (CT) scan using intravenous contrast (CT IV) as the sole type of contrast material, was studied as one method of evaluating children with suspected appendicitis. We felt that this technique could provide physicians with a faster and better-tolerated alternative to CT imaging which involves patients drinking oral contrast or needing rectal contrast administered.
SPECIFIC AIMS
- To test an imaging protocol using CT IV for the evaluation of suspected appendicitis in children in the setting of a pediatric emergency department (ED).
- To determine test performance characteristics (specificity, sensitivity and diagnostic accuracy) of CT IV in detecting appendicitis in children.
详细描述
This was to be a prospective cohort study imaging pediatric patients (3-18 years old) in whom the diagnosis of appendicitis was suspected, but not clinically apparent. Patients that were to have a CT performed would be invited to participate and if enrolled, would be imaged using CT scan with IV contrast alone.
CT scans would be interpreted in real time by a resident radiologist and/or an attending radiologist. ED evaluation would remain unchanged and patient disposition would be based on the discretion of the ED provider using all information (patient exam, labs, surgical consultation as needed and the results of the CT scan).
CT scan performance would be determined by comparison of the CT interpretation with patient final outcomes as determined by either (1) pathology reports - in patients that went on to have surgery (appendectomy) or (2) clinical phone follow up at 24 hrs and then 1 week after ED discharge.
Performance of CT would be compared between the resident and the attending radiologists.
Further, we would compare the time to obtain a CT scan (defined as ED triage time - Time to CT) between our study cohort and a retrospective cohort of patients who had received CT scan in the ED for evaluation of appendicitis pre-study (CT using BOTH IV and oral contrast).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 3 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 3- 18 years
- •Signs/symptoms for < 72 hours
- •CT Scan requested for evaluation by attending or fellow
排除标准
- •Clinically apparent appendicitis
- •Pregnancy
- •Sickle Cell Disease
- •Known contrast allergy
- •Previous enrollment
- •Signs/symptoms for > 72 hrs
- •Known abdominal disease (e.g. Crohn's)
- •Exam unreliable (neurologically impaired patient)
研究组 & 干预措施
1
cohort = pediatric patients in the ED (3-18 yo) with abdominal pain suspicious for appendicitis that are to undergo CT scan
干预措施: CT Scan using IV contrast alone (Other)
结局指标
主要结局
Sensitivity, Specificity, PPV, NPV for CT Scan with IV contrast alone
时间窗: Study completion date
次要结局
- Time to CT scan for CT with IV contrast alone v. CT using both IV and oral contrast(study completion date)