Diagnostic Performance of Point of Care Ultrasound to Identify Intestinal Obstruction

Bowel Obstruction Clinical Trial

— OCCLUS  

Official title:

Diagnostic Performance of Point of Care Ultrasound to Identify Intestinal Obstruction

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04848415
• Other study ID #: OCCLUS
• Status: Not yet recruiting
• Start date: May 1, 2021
• Est. completion date: September 1, 2022

Study information

• Verified date: April 2021
• Source: Nantes University Hospital
• Contact: Philippe LE CONTE, PhD
• Phone: 33 2 40 28 39 34
• Email: philippe.leconte[@]chu-nantes.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 150
• Est. completion date: September 1, 2022
• Est. primary completion date: May 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria :

• Adult patients

• Abdominal pain

• Suspected bowel obstruction

Exclusion Criteria :

• Documented end-of-life precluding CT realization

Related Conditions & MeSH terms

• Bowel Obstruction
• Intestinal Obstruction

Intervention

Other:
• Point-of-Care Ultrasound
Patients admitted to the ED with abdominal pain and suspicion of bowel obstruction : realization of a Point-of-Care Ultrasound after clinical exam by the Emergency Physician in charge as a standard of care. Beside usual findings, the investigators will search for signs of bowel obstruction: dilated and incompressible small bowel loop, back-and-forth peristalsis sign. Determination of probability of small bowel obstruction. Realization of a computed tomography in search of small bowel obstruction.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Nantes University Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Negative predictive value of POCUS	Negative predictive value of POCUS for the diagnosis of bowel obstruction compared with computed tomography result	Through ED stay, up to 24 hours
Secondary	Positive predictive value of POCUS for the diagnosis of bowel obstruction	Positive predictive value	Through ED stay, up to 24 hours
Secondary	Sensitivity of POCUS for the diagnosis of bowel obstruction	sensitivity of POCUS, for the diagnosis of bowel obstruction compared with computed tomography result	Through ED stay, up to 24 hours
Secondary	Specificity of POCUS for the diagnosis of bowel obstruction	specificity of POCUS, for the diagnosis of bowel obstruction compared with computed tomography result	Through ED stay, up to 24 hours