Clinical Trial: Accuracy of Ultrasonography for the Diagnosis of Pneumoperitoneum in the Emergency Department

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: Accuracy of Ultrasonography for the Diagnosis of Pneumoperitoneum in the Emergency Department

Brief Summary:

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.


Detailed Summary:
Sponsor: Azienda Ospedaliero-Universitaria Careggi

Current Primary Outcome: Accuracy of ultrasonography for the diagnosis of pneumoperitoneum [ Time Frame: 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


Original Primary Outcome: Same as current

Current Secondary Outcome: Accuracy of each scan and of each sonographic sign for the diagnosis of pneumoperitoneum [ Time Frame: No follow-up for the included patients. Outcome is measured one month after the end of recruitment ]

Original Secondary Outcome: Same as current

Information By: Azienda Ospedaliero-Universitaria Careggi

Dates:
Date Received: November 27, 2013
Date Started: January 2014
Date Completion:
Last Updated: April 22, 2015
Last Verified: April 2015