Relevance of Whole-body Computed Tomography Prescription in the Emergency Department : an Identification Tool for Low Risk Patients (PRE-SCEAU)

Pertinence de la PREscription du Scanner Corps-Entier Aux Urgences : un Outil d'Identification Des Patients à Bas Risque

The whole-body scanner (SCE) is a powerful examination that guides the management of patients severely traumatized. However, the systematic use of this examination in emergency departments is responsible for a large proportion of normal examinations. In addition to the non-negligible direct cost, the average irradiation of 20 mSv would give an adult a 1 in 1000 risk of developing a cancer. The Vittel score makes it possible to categorize pre-hospital patients as seriously traumatized to guide the sending of resources and direct them to a center equipped with a suitable technical platform.

The use of this score to condition the prescription of the ECS is at the origin of an over-triage important since one out of two patients who validates at least one criterion has no lesion on imaging. The purpose of this research project is to validate a decision support tool to objectively guide the emergency physician in its use of the ECS. At the same time, the economic impact of such a procedure will be analysed.

Study Overview

• Status: Recruiting
• Conditions: Trauma
• Intervention / Treatment: Diagnostic test: whole-body computed tomography

• Study Type: Observational
• Enrollment (Estimated): 2018

Contacts and Locations

• Study Contact: Name: David MALLET; Phone Number: 0033 2 32 88 82 65; Email: secretariat.DRC@chu-rouen.fr

Study Locations

• France
  • Rouen, France, 76031
    • Recruiting
    • Services des Urgences Adultes
    • Contact: Mehdi MI TAALBA, Dr; Phone Number: +33 (0)2 32 88 66 87; Email: mehdi.taalba@chu-rouen.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

All adult patients consulting in the emergency room after a trauma whose mechanism of injury is a fall or a road accident and indicated for the realization of a whole body scanner.

Description

Inclusion Criteria:

• Any adult patient undergoing an SCE as part of a post-traumatic lesion assessment during a stay in the emergency room.
• Mechanism of injury: road accident or fall.
• Patient having read and understood the information letter and given his oral consent.

Exclusion Criteria:

• Neurological impairment defined by a Glasgow score of less than 8.
• Respiratory failure with SpO2 < 90% on oxygen or with the use of ventilatory assistance.
• Hemodynamic failure with vascular filling greater than 1000 cc or recourse to catecholamines.
• Acute alcoholism.
• Taking narcotics.
• History of cognitive disorders.
• Current pregnancy.
• Suicidal patient.
• Trauma related to a brawl
• Penetrating trauma.
• Hemophilia.
• Known thrombocytopenia at the time of inclusion.
• Heart, lung, liver or kidney transplant patient.
• Person deprived of liberty by an administrative or judicial decision or person placed under legal safeguard / sub-tutorship or curatorship.

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PHASE I: Assess the negative predictive value of a 15-criteria score to exclude the traumatized patient from a whole-body CT (SCE) imaging strategy to emergencies.	The main judgment criterion is defined by the uselessness of the whole body scanner, evaluated from the SCE voucher which will contain the 15 criteria from phase I.	through study Phase 1 completion, an average of 1 year
PHASE II: To quantify the effective reduction in SCE requests after the validated score is made available on the SCE prescription vouchers.	The main judgment criterion is the prescription of an irrelevant whole-body scanner (a patient whose 15 safety criteria are validated).	through study Phase 2 completion, an average of 1 year

Collaborators and Investigators

• Sponsor: University Hospital, Rouen

Study record dates

Study Major Dates

• Study Start (Actual): June 23, 2023
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: October 14, 2022
• First Submitted That Met QC Criteria: October 18, 2022
• First Posted (Actual): October 20, 2022

Study Record Updates

• Last Update Posted (Actual): October 8, 2024
• Last Update Submitted That Met QC Criteria: October 3, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 2020/0425/HP

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
• product manufactured in and exported from the U.S.: No