Clinical trial NCT02004925: Accuracy of Ultrasonography for the Diagnosis of Pneumoperitoneum in the Emergency Department
Official title: Accuracy of Ultrasonography for the Diagnosis of Pneumoperitoneum in the Emergency Department
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pneumoperitoneum
Keywords: pneumoperitoneum
free peritoneal air
ultrasonography
Lead sponsor: Azienda Ospedaliero-Universitaria Careggi
Sponsor class: OTHER
First posted: 2013-12-09
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Patients more than 18 years presenting to emergency departments with acute abdominal pain and clinical suspected pneumoperitoneum

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.


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

Primary outcomes:
measure: Accuracy of ultrasonography for the diagnosis of pneumoperitoneum
timeFrame: No follow-up for the included patients. Outcome is measured one month after the end of recruitment
Secondary outcomes:
measure: Accuracy of each scan and of each sonographic sign for the diagnosis of pneumoperitoneum
timeFrame: No follow-up for the included patients. Outcome is measured one month after the end of recruitment
Other outcomes:
measure: Inter and intraobserver agreement between reviewers
timeFrame: No follow-up for the included patients. Outcome is measured one month after the end of recruitment
Locations:
city: Firenze
country: Italy
facility: Emergency Department Azienda Ospedaliera Universitaria Careggi
Study officials:
affiliation: Director of Emergency Department AUO Careggi
name: Stefano Grifoni, MD
role: STUDY_CHAIR
References:
citation: 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.