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Completed

NCT Number: NCT02004925

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Emergency Department Azienda Ospedaliera Universitaria Careggi

Florence, 50134, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • All patients more than 18 years with acute abdominal pain

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

Other outcomes

  1. Inter and intraobserver agreement between reviewers

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

    Concordance between the reviewers of the ultrasonographic videos for pneumoperitoneum diagnosis

Sponsors and collaborators

Lead sponsor

Azienda Ospedaliero-Universitaria Careggi

Other

Registry information

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Dec 9, 2013
Registry last updated
Apr 24, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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