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

NCT ID: NCT02004925

Last Updated: 2015-04-24

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 20 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-01-31
• Study Completion Date: 2014-09-30

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.

Conditions

Pneumoperitoneum

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Pneumoperitoneum

Patients with a diagnosis of pneumoperitoneum by CT or surgery

No interventions assigned to this group

no pneumoperitoneum

patients with acute abdominal pain with a diagnosis other than pneumoperitoneum in whom pneumoperitoneum was excluded by CT or surgery

No interventions assigned to this group

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Azienda Ospedaliero-Universitaria Careggi

OTHER

Sponsor Role: lead

Responsible Party

Peiman Nazerian

Medical Doctor Emergency Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Stefano Grifoni, MD

Role: STUDY_CHAIR

Director of Emergency Department AUO Careggi

Locations

Emergency Department Azienda Ospedaliera Universitaria Careggi

Florence, , Italy

Countries

Italy

References

Nazerian P, Tozzetti C, Vanni S, Bartolucci M, Gualtieri S, Trausi F, Vittorini M, Catini E, Cibinel GA, Grifoni S. Accuracy of abdominal ultrasound for the diagnosis of pneumoperitoneum in patients with acute abdominal pain: a pilot study. Crit Ultrasound J. 2015 Dec;7(1):15. doi: 10.1186/s13089-015-0032-6. Epub 2015 Oct 6.

Reference Type: DERIVED

PMID: 26443344 (View on PubMed)

Other Identifiers

070675

Identifier Type: -

Identifier Source: org_study_id