跳至主要内容
临床试验/NCT05864378
NCT05864378尚未招募不适用

The Impact of Point-of-care Ultrasound on the Diagnosis and Management of Small Bowel Obstruction in the Emergency Department: a Retrospective Observational Single-center Study

Azienda Ospedaliero-Universitaria di Modena0 个研究点目标入组 230 人开始时间: 2023年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
230
主要终点
Time to diagnosis of SBO by POCUS or CT scan

研究概览

简要总结

This study protocol aims to evaluate the impact of point-of-care ultrasound (POCUS) on the diagnosis and management of small bowel obstruction (SBO) in the emergency department (ED). SBO is a potentially life-threatening condition that requires prompt diagnosis and management. Currently, the diagnosis of SBO is based on clinical evaluation and imaging tests, including plain abdominal radiography and computed tomography (CT) scan. POCUS is a bedside imaging technique that is rapid, non-invasive, repeatable, cost-effective and radiation-free, and can provide valuable information for the diagnosis and management of SBO. The primary objective of this study is to compare the time to diagnosis of SBO between patients who undergo POCUS intestinal loops examination and those who do not undergo POCUS in the ED. The secondary objectives include comparing the hospital length of stay, the rate of surgical intervention, the rate of complications, and the mortality rate between the two groups. This is a monocentric retrospective cohort study that will include all adult patients (> 18 years old) who presented to the ED with suspected SBO. The study population will be divided into two groups: the POCUS group and the non-POCUS group. The sample size calculation will be based on the assumption of a 30% reduction in the time to diagnosis of SBO in the POCUS group compared to the non-POCUS group, with a power of 80%. The results of this study may provide more robust evidence on the diagnostic accuracy and impact of POCUS for SBO in the ED.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

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

  • Age > 18 years old
  • Clinical suspicion of SBO based on history and physical examination
  • Plain abdominal radiography (AXR) or CT scan performed in the ED

排除标准

  • Pregnancy
  • Known bowel obstruction
  • Previous abdominal surgery within 30 days
  • Refusal or inability to consent

结局指标

主要结局

Time to diagnosis of SBO by POCUS or CT scan

时间窗: All patients will be seen by the emergency physician within 6 hours of admission to the emergency department.

The primary outcome will be the time to diagnosis of SBO by POCUS or CT scan, defined as the interval between the ED arrival and the confirmation of SBO by either imaging modality, comparing the two groups.

次要结局

  • The hospital length of stay(Patients will be followed up for a maximum of 2 months from admission to the emergency department, until discharge or death.)
  • The rate of surgical intervention(Patients will be followed up for a maximum of 2 months from admission to the emergency department, until discharge or death.)
  • The rate of complications(Patients will be followed up for a maximum of 2 months from admission to the emergency department, until discharge or death.)
  • The mortality rate(Patients will be followed up for a maximum of 2 months from admission to the emergency department, until discharge or death.)

研究者

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

Carmine Cristiano Di Gioia

Attending physician

Azienda Ospedaliero-Universitaria di Modena

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