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.

Study Overview

• Status: Completed
• Conditions: Pneumoperitoneum

• Study Type: Observational
• Enrollment (Actual): 20

Contacts and Locations

Study Locations

• Italy
  • Firenze, Italy, 50134
    • Emergency Department Azienda Ospedaliera Universitaria Careggi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

2

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Azienda Ospedaliero-Universitaria Careggi
• Investigators: Study Chair: Stefano Grifoni, MD, Director of Emergency Department AUO Careggi

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: January 1, 2014
• Primary Completion (Actual): September 1, 2014
• Study Completion (Actual): September 1, 2014

Study Registration Dates

• First Submitted: November 27, 2013
• First Submitted That Met QC Criteria: December 3, 2013
• First Posted (Estimate): December 9, 2013

Study Record Updates

• Last Update Posted (Estimate): April 24, 2015
• Last Update Submitted That Met QC Criteria: April 22, 2015
• Last Verified: April 1, 2015

More Information

Terms related to this study

• Keywords: ultrasonography; pneumoperitoneum; free peritoneal air
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Peritoneal Diseases; Disease Attributes; Pneumoperitoneum; Emergencies
• Other Study ID Numbers: 070675