Menu
Recruiting NCT05588791

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

Observational Trauma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: whole-body computed tomography.
Who it may be relevant to
Registry conditions: Trauma. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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

Primary outcome measures

  • 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. [Time frame: 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. [Time frame: through study Phase 2 completion, an average of 1 year]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Study design

Observational model
Other

Study locations

France · 1 center
  • Services des Urgences Adultes — Rouen

Identifiers

NCT: NCT05588791 · 2020/0425/HP

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗