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

NCT02004925 | Completed

• 1 other identifier: 070675
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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

Keywords

pneumoperitoneum; free peritoneal air; ultrasonography

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• 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

Other Outcomes (1)

• Inter and intraobserver agreement between reviewers

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

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients more than 18 years presenting to emergency departments with acute abdominal pain and clinical suspected pneumoperitoneum

You may qualify if:

• All patients more than 18 years with acute abdominal pain

You may not qualify if:

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

Sponsors & Collaborators

• Azienda Ospedaliero-Universitaria Careggi: lead

Study Sites (1)

Emergency Department Azienda Ospedaliera Universitaria Careggi

Florence, 50134, Italy

Location

Related Publications (1)

• 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.

  PMID: 26443344 DERIVED

MeSH Terms

Conditions

Pneumoperitoneum

Condition Hierarchy (Ancestors)

Peritoneal Diseases; Digestive System Diseases

Study Officials

• Stefano Grifoni, MD

  Director of Emergency Department AUO Careggi

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor Emergency Medicine

Study Record Dates

• First Submitted: November 27, 2013
• First Posted: December 9, 2013
• Study Start: January 1, 2014
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2014
• Last Updated: April 24, 2015

Record last verified: 2015-04

Locations

IT (1)