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

Recruiting

• Conditions: Trauma

• Registration Number: NCT05588791
• Lead Sponsor: University Hospital, Rouen

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-10-14
• Study First Submitted QC: 2022-10-18
• Study First Posted: 2022-10-20
• Study Start: 2023-06-23
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-03
• Last Update Posted: 2024-10-07
• Primary Completion: 2026-06-01
• Study Completion: 2026-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2018

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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).
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.

Trial Locations

Locations (1)

Services des Urgences Adultes; 🇫🇷 Rouen, France