PneumoperitoneumNCT02004925
Accuracy of Ultrasonography for the Diagnosis of Pneumoperitoneum in the Emergency Department
An observational study of Pneumoperitoneum, run by Azienda Ospedaliero-Universitaria Careggi at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pneumoperitoneum
- How many people
- 20 participants
- Where
- 1 siteItaly
- Study dates
- Jan 2014to Sep 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients more than 18 years presenting to emergency departments with acute abdominal pain and clinical suspected pneumoperitoneum
Who may be able to join
- All patients more than 18 years with acute abdominal pain
Who cannot join
- Refused consent
- Less than 18 years old
- Not possible to perform ultrasonography
Trial locations and contacts
1 site in 1 country.
Italy1 site
Emergency Department Azienda Ospedaliera Universitaria Careggi
Florence, 50134
About this study
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
- Medical subject headings
- Pneumoperitoneum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of ultrasonography for the diagnosis of pneumoperitoneum
CT or surgery are considered the gold standard for the diagnosis of pneumoperitoneum
Measured: 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
Measured: No follow-up for the included patients. Outcome is measured one month after the end of recruitment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2013 (estimated)
- Study startJan 2014
- Primary completionSep 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PneumoperitoneumStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliero-Universitaria Careggi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peiman Nazerian, Azienda Ospedaliero-Universitaria Careggi
- Investigators
- Stefano Grifoni, MD, Study chair, Director of Emergency Department AUO Careggi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02004925
- Sponsor's protocol ID
- 070675
- Status last verified
- Apr 2015
- First submitted
- 27 Nov 2013
- Last updated
- 24 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 26443344
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accuracy of Ultrasonography for the Diagnosis of Pneumoperitoneum in the Emergency Department
- ClinicalTrials.gov ID
- NCT02004925
- Acronym / sponsor ID
- 070675
- Conditions
- Pneumoperitoneum
- Keywords
- pneumoperitoneum, free peritoneal air, ultrasonography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Azienda Ospedaliero-Universitaria CareggiUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 9 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients more than 18 years presenting to emergency departments with acute abdominal pain and clinical suspected pneumoperitoneum
Key inclusion criteria (1 listed)
- All patients more than 18 years with acute abdominal pain
Key exclusion criteria (3 listed)
- Refused consent
- Less than 18 years old
- Not possible to perform ultrasonography
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Accuracy of ultrasonography for the diagnosis of pneumoperitoneum
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
1 secondary outcome
Accuracy of each scan and of each sonographic sign for the diagnosis of pneumoperitoneum
Time frame: No follow-up for the included patients. Outcome is measured one month after the end of recruitment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2015.
- Derived from this study: PubMed 26443344Nazerian 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stefano Grifoni, MD study chair
Director of Emergency Department AUO Careggi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pneumoperitoneum, run by Azienda Ospedaliero-Universitaria Careggi at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of ultrasonography for the diagnosis of pneumoperitoneum (time frame: No follow-up for the included patients. Outcome is measured one month after the end of recruitment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02004925, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2015.