Clinical trial NCT05588791: Relevance of Whole-body Computed Tomography Prescription in the Emergency Department : an Identification Tool for Low Risk Patients
Official title: Pertinence de la PREscription du Scanner Corps-Entier Aux Urgences : un Outil d'Identification Des Patients à Bas Risque
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Trauma
Lead sponsor: University Hospital, Rouen
Sponsor class: OTHER
First posted: 2022-10-20
Enrollment: 2018
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: PROSPECTIVE
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.

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.


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.

Primary outcomes:
measure: 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.
timeFrame: through study Phase 1 completion, an average of 1 year
measure: PHASE II: To quantify the effective reduction in SCE requests after the validated score is made available on the SCE prescription vouchers.
timeFrame: through study Phase 2 completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Rouen
country: France
facility: Services des Urgences Adultes
Study officials:
References: