跳至主要内容
临床试验/NCT02004925
NCT02004925已完成不适用

Accuracy of Ultrasonography for the Diagnosis of Pneumoperitoneum in the Emergency Department

Azienda Ospedaliero-Universitaria Careggi1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2014年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
20
试验地点
1
主要终点
Accuracy of ultrasonography for the diagnosis of pneumoperitoneum

研究概览

简要总结

Pneumoperitoneum could be due to life threatening conditions and its quickly diagnosis is important in the emergency department (ED). Signs and symptoms are non-specific and radiography has low accuracy in the acute setting. Computed tomography (CT) is considered the gold standard, however it is not a cost-effective option in the vast population of patients with abdominal pain. Ultrasonography is able to detect as little as 2 ml of free air, however diagnostic accuracy of ultrasonography remains unclear. This study evaluates the accuracy of ultrasonography for the diagnosis of pneumoperitoneum, the most accurate abdominal scan and the most accurate echographic sign for the detection of free air.

Methods Consecutive patients presenting to ED for acute abdominal pain and with a diagnosis of pneumoperitoneum at CT or at surgery (study group) and a similar number of patients without a diagnosis of pneumoperitoneum (control group) undergo abdominal ultrasonography in a standardized protocol that include 10 scans for each patient registered on a video of 5 seconds. The videos are randomly reviewed by 4 sonographers and by 2 physicians with no experience in ultrasonography blind to final diagnosis and to all clinical data with the aim of detecting for each scan pneumoperitoneum. Accuracy of ultrasonography for the diagnosis of pneumoperitoneum will be calculated considering CT or surgery as gold standard. Furthermore intra and interobserver agreement and the accuracy of each ultrasonographic sign and scan will be calculated.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • All patients more than 18 years with acute abdominal pain

排除标准

  • Refused consent
  • Less than 18 years old
  • Not possible to perform ultrasonography

结局指标

主要结局

Accuracy of ultrasonography for the diagnosis of pneumoperitoneum

时间窗: No follow-up for the included patients. Outcome is measured one month after the end of recruitment

CT or surgery are considered the gold standard for the diagnosis of pneumoperitoneum

次要结局

  • Accuracy of each scan and of each sonographic sign for the diagnosis of pneumoperitoneum(No follow-up for the included patients. Outcome is measured one month after the end of recruitment)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Peiman Nazerian

Medical Doctor Emergency Medicine

Azienda Ospedaliero-Universitaria Careggi

研究点 (1)

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