Diagnostic Performance of Point of Care Ultrasound to Identify Intestinal Obstruction (OCCLUS)

April 16, 2021 updated by: Nantes University Hospital

As reported in previous studies, Point-of-Care Ultrasound (POCUS) has good performance for the diagnosis of bowel obstruction even when compared with CT. This inexpensive, radiation-free tool is available in a majority of ED. It is performed at the patient's bedside with immediate results. The learning curve allows Emergency Physicians (EP) to perform this exam after a relative brief training period.

The investigators aim to investigate the ability of POCUS performed before CT to exclude the diagnosis of bowel obstruction in patients admitted for abdominal pain.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Bowel obstruction (BO) is frequently suspected in the Emergency Department (ED). Computed Tomography (CT) is commonly used to diagnose this disease. However, CT is not always available in real-time, requires technician times, is associated with increased cost and exposes patients to radiations.

The researchers will investigate the diagnosis performances of POCUS for the diagnosis of BO with comparison with CT which will be considered as the gold standard. The wain objective will be the ability to exclude the diagnosis of BO, the main criteria being the negative predictive value. The secondary objectives will be the diagnosis performances (sensitivity, specificity, positive predictive value), duration and difficulty of POCUS

Study Type

Observational

Enrollment (Anticipated)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adult patients admitted to the ED for abdominal pain and suspicion of bowel obstruction

Description

Inclusion Criteria :

  • Adult patients
  • Abdominal pain
  • Suspected bowel obstruction

Exclusion Criteria :

- Documented end-of-life precluding CT realization

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Negative predictive value of POCUS
Time Frame: Through ED stay, up to 24 hours
Negative predictive value of POCUS for the diagnosis of bowel obstruction compared with computed tomography result
Through ED stay, up to 24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Positive predictive value of POCUS for the diagnosis of bowel obstruction
Time Frame: Through ED stay, up to 24 hours
Positive predictive value
Through ED stay, up to 24 hours
Sensitivity of POCUS for the diagnosis of bowel obstruction
Time Frame: Through ED stay, up to 24 hours
sensitivity of POCUS, for the diagnosis of bowel obstruction compared with computed tomography result
Through ED stay, up to 24 hours
Specificity of POCUS for the diagnosis of bowel obstruction
Time Frame: Through ED stay, up to 24 hours
specificity of POCUS, for the diagnosis of bowel obstruction compared with computed tomography result
Through ED stay, up to 24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nantes University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

May 1, 2021

Primary Completion (ANTICIPATED)

May 1, 2022

Study Completion (ANTICIPATED)

September 1, 2022

Study Registration Dates

First Submitted

February 15, 2021

First Submitted That Met QC Criteria

April 16, 2021

First Posted (ACTUAL)

April 19, 2021

Study Record Updates

Last Update Posted (ACTUAL)

April 19, 2021

Last Update Submitted That Met QC Criteria

April 16, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OCCLUS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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