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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05588791
Acronym
PRE-SCEAU
Enrollment
2018
Registered
2022-10-20
Start date
2023-06-23
Completion date
2026-12-01
Last updated
2024-10-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Trauma

Brief summary

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.

Interventions

DIAGNOSTIC_TESTwhole-body computed tomography

whole-body computed tomography prescription in the emergency department : an identification tool for low risk patients

Sponsors

University Hospital, Rouen
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

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.

Design outcomes

Primary

MeasureTime frameDescription
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.through study Phase 1 completion, an average of 1 yearThe 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.
PHASE II: To quantify the effective reduction in SCE requests after the validated score is made available on the SCE prescription vouchers.through study Phase 2 completion, an average of 1 yearThe main judgment criterion is the prescription of an irrelevant whole-body scanner (a patient whose 15 safety criteria are validated).

Countries

France

Contacts

Primary ContactDavid MALLET
secretariat.DRC@chu-rouen.fr0033 2 32 88 82 65

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026