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

Pneumoperitoneum Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02004925
• Other study ID #: 070675
• Status: Completed
• Phase: N/A
• First received: November 27, 2013
• Last updated: April 22, 2015
• Start date: January 2014
• Est. completion date: September 2014

Study information

• Verified date: April 2015
• Source: Azienda Ospedaliero-Universitaria Careggi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Pneumoperitoneum

Locations

Country	Name	City	State
Italy	Emergency Department Azienda Ospedaliera Universitaria Careggi	Firenze

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Ospedaliero-Universitaria Careggi

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Inter and intraobserver agreement between reviewers	Concordance between the reviewers of the ultrasonographic videos for pneumoperitoneum diagnosis	No follow-up for the included patients. Outcome is measured one month after the end of recruitment	No
Primary	Accuracy of ultrasonography for the diagnosis of pneumoperitoneum	CT or surgery are considered the gold standard for the diagnosis of pneumoperitoneum	No follow-up for the included patients. Outcome is measured one month after the end of recruitment	No
Secondary	Accuracy of each scan and of each sonographic sign for the diagnosis of pneumoperitoneum		No follow-up for the included patients. Outcome is measured one month after the end of recruitment	No