Ireland
--:--IST
Recruiting Observational

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

NCT05588791 · tracked via the Priya Life Science France tracker
Phase
Observational
Started
2023-06-23
Last updated
2024-10-08

Condition(s) studied

Trauma

Investigational drug(s) / intervention(s)

whole-body computed tomography

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

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • 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 year
    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.
  • 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 year
    The main judgment criterion is the prescription of an irrelevant whole-body scanner (a patient whose 15 safety criteria are validated).

Trial sites (1)

FacilityCityRegionStatus
Services des Urgences Adultes Rouen France Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05588791 on ClinicalTrials.gov ↗ ← All trials in France