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

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ClinicalTrials.gov Identifier: NCT02004925
Recruitment Status : Completed
First Posted : December 9, 2013
Last Update Posted : April 24, 2015
Sponsor:
Information provided by (Responsible Party):
Peiman Nazerian, Azienda Ospedaliero-Universitaria Careggi

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.


Condition or disease
Pneumoperitoneum

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Study Type : Observational
Actual Enrollment : 20 participants
Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Accuracy of Ultrasonography for the Diagnosis of Pneumoperitoneum in the Emergency Department
Study Start Date : January 2014
Actual Primary Completion Date : September 2014
Actual Study Completion Date : September 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound

Group/Cohort
Pneumoperitoneum
Patients with a diagnosis of pneumoperitoneum by CT or surgery
no pneumoperitoneum
patients with acute abdominal pain with a diagnosis other than pneumoperitoneum in whom pneumoperitoneum was excluded by CT or surgery



Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients more than 18 years presenting to emergency departments with acute abdominal pain and clinical suspected pneumoperitoneum
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02004925


Locations
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Italy
Emergency Department Azienda Ospedaliera Universitaria Careggi
Firenze, Italy, 50134
Sponsors and Collaborators
Azienda Ospedaliero-Universitaria Careggi
Investigators
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Study Chair: Stefano Grifoni, MD Director of Emergency Department AUO Careggi

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Peiman Nazerian, Medical Doctor Emergency Medicine, Azienda Ospedaliero-Universitaria Careggi
ClinicalTrials.gov Identifier: NCT02004925     History of Changes
Other Study ID Numbers: 070675
First Posted: December 9, 2013    Key Record Dates
Last Update Posted: April 24, 2015
Last Verified: April 2015

Keywords provided by Peiman Nazerian, Azienda Ospedaliero-Universitaria Careggi:
pneumoperitoneum
free peritoneal air
ultrasonography

Additional relevant MeSH terms:
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Emergencies
Pneumoperitoneum
Disease Attributes
Pathologic Processes
Peritoneal Diseases
Digestive System Diseases