Contribution of Point of Care Ultrasound by the Emergency Physician to Rule Out the Small Bowel Obstruction: a Diagnostic, Multicenter Study

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorNantes University Hospital

About this trial

Small Bowel Obstruction (SBO) is a frequent pathology in the emergency department (ED). Diagnosis is currently based on abdominal CT scan (CT). Moreover, CT is warranted to determine the therapeutic strategy in patients with SBO which could include medical treatment; surgical intervention or both. However, CT is associated with drawbacks such as radiation exposure, increased cost and ED length-of-stay.

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Major patient (age > 18 years old), no upper limit

Patient admitted to the ED with suspected SBO (abdominal pain, vomiting, cessation of gas and feces...)

Low or moderate pretest Gestalt clinical probability

Patient able to understand protocol and express agreement

Disqualifiers

Patient under legal guardianship

Pregnant women

Nursing mothers

Patient who does not speak or understand French

Trial population

Patients with suspected SBO, with low or moderate Gestalt probability and who meet the inclusion criteria (and without any non inclusion criteria)

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Point of care ultrasound

    Other intervention

    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

Treatment groups

667 Participants
are divided into 1 treatment group
Group A: POCUS1 intervention

Trial outcomes

Primary outcomes

1

Estimate the ability of POCUS to rule-out SBO in patients with low or moderate Gestalt clinical probability

Evaluation of the negative predictive value (NPV) of point of care ultrasound (POCUS) in patients with suspected Small Bowel Obstruction (SBO) (number of patients with negative POCUS in patients without SBO according to the CT (gold standard) divided by total patients with negative POCUS)

Time frame
Day 1

Secondary outcomes

1

1/ Diagnostic accuracy of POCUS for the diagnosis of SBO

1/ Sensitivity, specificity, positive predictive value of POCUS determined from POCUS and CT results.

Time frame
Day 1
2

2/ Estimation of time between POCUS and CT report

2/ Time between point of care ultrasound and CT report

Time frame
Day 1
3

3a/ Description of "false negative" (exclusion of SBO diagnosis by POCUS, but diagnosis of SBO by CT)

3a/ Characteristics associated with false negative (BMI, sex, age, physician\'s experience, physician\'s evaluation of POCUS difficulty on a numerical scale from 0 to 10)

Time frame
Day 1
4

3b/ Description of "false positive" (SBO diagnosis by POCUS, but diagnosis of SBO excluded by CT)

3b/ Characteristics associated with false positive (BMI, sex, age, physician\'s experience, physician\'s evaluation of POCUS difficulty on a numerical scale from 0 to 10)

Time frame
Day 1

Other outcomes

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