The Role of Contrast Enhanced Ultrasound in The Diagnosis of Children With Appendicitis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 37
- 试验地点
- 1
- 主要终点
- Number of Children With an Accurate Diagnosis of Appendicitis.
研究概览
简要总结
This study seeks to determine the efficacy of Contrast Enhanced Ultrasound (CEUS) in improving the diagnosis of acute appendicitis in children, when compared to the standard grey-scale ultrasound.
详细描述
This will be a single-center, non-randomized trial that will add to our institution's current diagnostic algorithm using Contrast Enhanced Ultra Sound (CEUS) in subjects who are clinically suspicious for acute appendicitis.
For those who consent to study participation, we propose obtaining a CEUS after the initial gray-scale ultrasound. Once the initial ultrasound is complete, the contrast Lumason® (sulfur hexafluoride lipid type-A microspheres) will be administered through an already existing IV catheter and an abdominal scan will be completed. The patient will then continue with standard of care treatment per his treating physician. The CEUS image will be read at a future time by a Children's Mercy Hospital radiologist blinded to the results of the gray scale ultrasound and computed tomography (CT) scan if one was obtained; these will be used for comparison.
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
The CEUS image will be read at a future time by a Children's Mercy Hospital radiologist blinded to the results of the gray scale ultrasound and computed tomography (CT) scan if one was obtained; these will be used for comparison.
入排标准
- 年龄范围
- 8 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Present to Children's Mercy Adele Hall campus with a clinical concern for acute appendicitis
- •Age 8 through 17 years
- •seen between Institutional Review Board (IRB) approval date and 12/31/2019
- •Seen Monday- Friday between the hours of 9:00 a.m. and 4:00 pm
- •Has had an IV catheter placed as part of their standard of care
排除标准
- •Known cardiac abnormality
- •Pulmonary hypertension
- •Known sensitivity to sulfur hexafluoride, polyethylene glycol 4000, distearoylphosphatidylcholine (DSPC), dipalmitoylphosphatidylglycerol sodium (DPPG-Na), or palmitic acid
- •Does not had an IV catheter placed
- •Unable to roll over
- •Unable to assent
- •Lactating
- •Received an ultrasound image from a referring facility
研究组 & 干预措施
Experimental
IV sulfur hexafluoride lipid-type A microspheres, 0.03 mL/kg, up to 2 doses per examination, total dose not to exceed 4.8 mL. Single examination per patient.
干预措施: Sulfur hexafluoride lipid-type A microspheres (Drug)
结局指标
主要结局
Number of Children With an Accurate Diagnosis of Appendicitis.
时间窗: 1 week
Number of children with an accurate diagnosis of appendicitis when compared to the standard grey scale ultrasound and/ or CT scan based on the following categories: Category 1: Normal appendix Category 2: Appendix not fully visualized without secondary signs Category 3: Appendix not fully visualized with secondary signs Category 4: Appendicitis
次要结局
- Definitive Diagnosis(1 week)
- Number of Participants Who Required Additional CT Scan(30 days)
- Percentage of Negative Appendectomies(1 week)
- Total Cost Difference Compared to Traditional Ultrasound(60 days)
- Total Cost Difference Between Traditional Ultrasound in Comparison to Costs in CT Scan.(60 days)
研究者
Tolulope Oyetunji
MD, Director, Health Outcomes Research, Department of Surgery
Children's Mercy Hospital Kansas City