Contribution of Point of Care Ultrasound by the Emergency Physician to Rule Out the Small Bowel Obstruction: a Diagnostic, Multicenter Study
NCT ID: NCT06803628
Last Updated: 2025-04-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
667 participants
OBSERVATIONAL
2025-03-10
2027-03-10
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
In a prospective observational study, a SBO was excluded by CT in 45% \[95%CI: 37-53\] of patients. There is, thus, a need for improving the appropriateness of CT-scan for suspected SBO.
A recent meta-analysis showed that Point of care ultrasound (POCUS) had a good diagnostic accuracy (sensitivity 83% \[95%CI 71.7%-90.4%\]), specificity 93% \[95%CI 55.3%-99.3%\]). Another meta-analysis found rather similar results (sensitivity 83% \[(95% CI 89.0% to 94.7%\], specificity 96,6% \[95% CI 88.4% to 99.1%\]).
In order to improve the negative predictive value of POCUS for its implementation as a rule-out strategy, CHU of Nantes emergency unit studied the combination of POCUS with Gestalt pre-test probability of SBO determined by the emergency physician. This SBO probability classified the patients as low, moderate or high risk of SBO. In patients with low or moderate Gestalt probability, CHU of Nantes emergency unit found that this combined strategy had a sensitivity of 100% \[95% CI: 88-100\] and NPV 100% \[92-100%\].
By (i) focusing on patients with a low or moderate Gestalt clinical probability and (ii) increasing the number of patients included, CHU of Nantes emergency unit intends to demonstrate that POCUS is able to exclude SBO in this population. This would avoid unnecessary CT and thus lower costs, ED length-of-stay and hospital radiologists workload.
A POCUS will be performed followed by a CT (gold standard). The main objective will be the ability of POCUS to rule-out SBO in patients with low or moderate Gestalt clinical probability.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
POCUS for Small Bowel Obstruction in the ED: a Retrospective Study
NCT05864378
Diagnostic Performance of Point of Care Ultrasound to Identify Intestinal Obstruction
NCT04848415
Ultrasound Emergency Diagnosis of Small Bowel Obstruction
NCT03226665
A Multicenter Retrospective Review of Management Strategies in Small Bowel Obstruction
NCT06223620
SnapSBO - Small Bowel Obstruction Snapshot Audit
NCT05843097
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
A recent meta-analysis including 1178 patients showed that Point of care ultrasound (POCUS) had a good diagnostic accuracy (sensitivity 83% \[95%CI 71.7%-90.4%\]), specificity 93% \[95%CI 55.3% -99.3%\]). Another meta-analysis with 433 patients, found rather similar results: sensitivity 83% \[95% CI 89.0% to 94.7%\], specificity 96,6% \[95% CI 88.4% to 99.1%\]).
Since CT is almost warranted to guide the treatment strategy, which could include surgery, medical treatment or both, CHU of Nantes emergency unit explored a different approach focusing on POCUS rule-out ability. This study also introduced the notion of SBO Gestalt probability which is a global clinical evaluation by the physician. Gestalt probability has mainly been explored in patients with suspected pulmonary embolism and was found as effective as clinical prediction rules. It is used in the routine clinical evaluation of patient with suspicion of pulmonary embolism. When applied to patients with SBO suspicion, the physician chooses between low, moderate or high risk of SBO. Based on CT results, prevalence of SBO based on Gestalt probability were 21%, 45% and 87% in the low, moderate and high risks, respectively.
Our team studied POCUS with the following items that were searched in the whole abdomen divided into nine zones: dilated incompressible fluid-filled intestinal loop (\>25 mm) with back-and-forth fluid movement. When at least one of these signs was present in one zone, the SBO was highly suspected. As it was an observational study, a CT was performed in all patients and was the gold standard. This approach was associated with a POCUS sensitivity in the whole population of 99% \[95% CI: 93-99.8\] \[2\]. POCUS would thus have a role in patients with low and moderate SBO risks because the prevalence of SBO was major in the high risk Gestalt probability category of patients, and thus CT is the only imaging needed in these latter. Furthermore, in patients with low or moderate probability, the sensitivity was 100% \[95% CI: 88-100\] In previous studies, the sensitivity was not able to exclude SBO with sufficient security since the lower 95% confidence interval margin was near 90%. By (i) focusing on patients with a low or moderate clinical Gestalt probability and (ii) increasing the number of patients, CHU of Nantes emergency unit intends to demonstrate that POCUS should be able to safely exclude SBO in this population.
In case of positive results, the diagnostic strategy in case of SBO suspicion could be modified in: firstly, assess the clinical Gestalt probability; secondly perform a POCUS in patients with low or moderate Gestalt probability and thirdly, prescribe a CT only for patients with high clinical probability or presence of POCUS signs of SBO. This would avoid unnecessary CT and thus lower patient's.
exposure, costs, ED length-of-stay and radiologist workload. A study performed in the USA simulated a POCUS first approach in patients with suspected SBO and found that it could save ED length of stay, radiation and money. In France in 2017, about ¾ of ED were equipped with ultrasound machines and half of the emergency physicians were trained in POCUS. Furthermore, SBO detection is easily performed: in our study, the operator self-assessed ultrasound experience was beginner or intermediate for 59% of patients. In case of positive results, this technique would be largely deployed.
Inclusion criteria will be patients with low or moderate Gestalt clinical probability of SBO. A POCUS will be performed followed by a CT (gold standard). This CT will be realized and interpreted blindly from the POCUS results. The main objective will be the ability of POCUS to rule-out SBO in patients with low or moderate Gestalt clinical probability
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
POCUS
Point of care ultrasound in Small bowel obstruction in Emergency Medicine,
Point of care ultrasound
OCCLUS-POCUS will include patients with suspected SBO, with low or moderate Gestalt probability who meet the inclusion criteria During the patient's visit to the ED, the investigating physician will present the study and the importance of evaluating the value of POCUS in the diagnosis of exclusion of SBO. Once oral non-opposition to the study has been obtained, the participation of the patient lasts 28 days.
POCUS is performed only for patients with low or moderate Gestalt probability. It will be performed by trained emergency physicians (EP) using a curvilinear probe . After POCUS realization, the EP will:
* determine if there is presence or absence of SBO.
* collect POCUS duration, difficulty and investigator's characteristics.
* Realization of CT which will be the gold standard for SBO presence or absence.
* The study protocol procedure ends when the report of the CT is available and the physician establish its diagnosis.
* The study ends at D28 with a phone call
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Point of care ultrasound
OCCLUS-POCUS will include patients with suspected SBO, with low or moderate Gestalt probability who meet the inclusion criteria During the patient's visit to the ED, the investigating physician will present the study and the importance of evaluating the value of POCUS in the diagnosis of exclusion of SBO. Once oral non-opposition to the study has been obtained, the participation of the patient lasts 28 days.
POCUS is performed only for patients with low or moderate Gestalt probability. It will be performed by trained emergency physicians (EP) using a curvilinear probe . After POCUS realization, the EP will:
* determine if there is presence or absence of SBO.
* collect POCUS duration, difficulty and investigator's characteristics.
* Realization of CT which will be the gold standard for SBO presence or absence.
* The study protocol procedure ends when the report of the CT is available and the physician establish its diagnosis.
* The study ends at D28 with a phone call
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Patient admitted to the ED with suspected SBO (abdominal pain, vomiting, cessation of gas and feces...)
3. Low or moderate pretest Gestalt clinical probability
4. Patient able to understand protocol and express agreement
5. Oral non-opposition given
Exclusion Criteria
2. Pregnant women
3. Nursing mothers
4. Patient who does not speak or understand French
5. Patient without a health insurance plan
6. Patient who already had imaging confirming the diagnosis
7. Patient who participates simultaneously in any interventional study focused on abdominal pain
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Nantes University Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Chu Clermont-Ferrand Hopital Gabriel Montpied
Clermont-Ferrand, France, France
Ghem Groupe Hospitalier Eaubonne Montmorency Simone Veil
Eaubonne, France, France
CHD Vendée
La Roche-sur-Yon, France, France
Ap-Hm Hopital La Timone
Marseille, France, France
Hôpital Nord
Marseille, France, France
Ghsif Groupe Hospitalier Sud Ile de Franc _ Ch Melun
Melun, France, France
CHU Nantes
Nantes, France, France
Le Confluent
Nantes, France, France
CHU CAREMEAU - Nimes
Nîmes, France, France
AP-HP Est Parisien _ ST-ANTOINE
Paris, France, France
P-HP Paris Centre - COCHIN
Paris, France, France
Chru Poitiers
Poitiers, France, France
CH MEMORIAL - Saint Lô
Saint-Lô, France, France
CH Saint-Nazaire
Saint-Nazaire, France, France
Groupe Hospitalier Selestat Obernai (Ghso)
Sélestat, France, France
Hopital PURPAN CHU Toulouse
Toulouse, France, France
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
RC24_0388
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.