Emergency Department Azienda Ospedaliera Universitaria Careggi
Florence, 50134, Italy
NCT Number: NCT02004925
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.
Looking for future studies?
Notify Me18 year and older
All sexes
Observational
Florence, 50134, Italy
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: No follow-up for the included patients. Outcome is measured one month after the end of recruitment
CT or surgery are considered the gold standard for the diagnosis of pneumoperitoneum
Time frame: No follow-up for the included patients. Outcome is measured one month after the end of recruitment
Time frame: No follow-up for the included patients. Outcome is measured one month after the end of recruitment
Concordance between the reviewers of the ultrasonographic videos for pneumoperitoneum diagnosis
Azienda Ospedaliero-Universitaria Careggi
Other
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07438132
Digestive System Diseases, Laparoscopic Surgery
Taipei, Taiwan
View Trial DetailsNCT07162922
Digestive System Diseases, Increased Intracranial Pressure Disorders
Kocaeli, Izmit, Turkey (Türkiye)
View Trial DetailsNCT07054138
Body Weight, Dexmedetomidine
Tanta, El-Gharbia, Egypt
View Trial DetailsNCT06075836
Atelectasis, Bronchial Diseases
Oxford, Oxfordshire, United Kingdom
View Trial Details