POCUS for Small Bowel Obstruction in the ED: a Retrospective Study

NCT05864378 | Unknown

• 1 other identifier: SBOCUS2023
• Study Type: observational
• Target: 230
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study protocol aims to evaluate the impact of point-of-care ultrasound (POCUS) on the diagnosis and management of small bowel obstruction (SBO) in the emergency department (ED). SBO is a potentially life-threatening condition that requires prompt diagnosis and management. Currently, the diagnosis of SBO is based on clinical evaluation and imaging tests, including plain abdominal radiography and computed tomography (CT) scan. POCUS is a bedside imaging technique that is rapid, non-invasive, repeatable, cost-effective and radiation-free, and can provide valuable information for the diagnosis and management of SBO. The primary objective of this study is to compare the time to diagnosis of SBO between patients who undergo POCUS intestinal loops examination and those who do not undergo POCUS in the ED. The secondary objectives include comparing the hospital length of stay, the rate of surgical intervention, the rate of complications, and the mortality rate between the two groups. This is a monocentric retrospective cohort study that will include all adult patients (\> 18 years old) who presented to the ED with suspected SBO. The study population will be divided into two groups: the POCUS group and the non-POCUS group. The sample size calculation will be based on the assumption of a 30% reduction in the time to diagnosis of SBO in the POCUS group compared to the non-POCUS group, with a power of 80%. The results of this study may provide more robust evidence on the diagnostic accuracy and impact of POCUS for SBO in the ED.

Conditions

Small Bowel Obstruction; Point of Care Ultrasound

Keywords

POCUS; SBO

Outcome Measures

Primary Outcomes (1)

• Time to diagnosis of SBO by POCUS or CT scan

  The primary outcome will be the time to diagnosis of SBO by POCUS or CT scan, defined as the interval between the ED arrival and the confirmation of SBO by either imaging modality, comparing the two groups.

  All patients will be seen by the emergency physician within 6 hours of admission to the emergency department.

Secondary Outcomes (4)

• The hospital length of stay

  Patients will be followed up for a maximum of 2 months from admission to the emergency department, until discharge or death.

• The rate of surgical intervention

  Patients will be followed up for a maximum of 2 months from admission to the emergency department, until discharge or death.

• The rate of complications

  Patients will be followed up for a maximum of 2 months from admission to the emergency department, until discharge or death.

• The mortality rate

  Patients will be followed up for a maximum of 2 months from admission to the emergency department, until discharge or death.

Study Arms (2)

The POCUS group

Patients who were evaluated by ED physicians who perform POCUS intestinal loops examination as part of their clinical practice

The non-POCUS group

Patients who were evaluated by ED physicians who do not perform POCUS intestinal loops examination for any reason

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will be divided into two groups: 1. The POCUS group: patients who were evaluated by ED physicians who perform POCUS intestinal loops examination as part of their clinical practice 2. The non-POCUS group: patients who were evaluated by ED physicians who do not perform POCUS intestinal loops examination for any reason.

You may qualify if:

• Age \> 18 years old
• Clinical suspicion of SBO based on history and physical examination
• Plain abdominal radiography (AXR) or CT scan performed in the ED

You may not qualify if:

• Pregnancy
• Known bowel obstruction
• Previous abdominal surgery within 30 days
• Refusal or inability to consent

Sponsors & Collaborators

• Azienda Ospedaliero-Universitaria di Modena: lead

Central Study Contacts

Carmine Cristiano Di Gioia

CONTACT

+39 3493812503; cristianodigioia@icloud.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending physician

Study Record Dates

• First Submitted: May 9, 2023
• First Posted: May 18, 2023
• Study Start: September 1, 2023
• Primary Completion: December 31, 2023
• Study Completion: February 1, 2024
• Last Updated: May 18, 2023

Record last verified: 2023-05