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

Trauma Clinical Trial

— PRE-SCEAU  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05588791
• Other study ID #: 2020/0425/HP
• Status: Not yet recruiting
• Start date: January 1, 2023
• Est. completion date: December 1, 2026

Study information

• Verified date: October 2022
• Source: University Hospital, Rouen
• Contact: David MALLET
• Phone: 0033 2 32 88 82 65
• Email: secretariat.DRC[@]chu-rouen.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 2018
• Est. completion date: December 1, 2026
• Est. primary completion date: June 1, 2026
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Trauma

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Rouen

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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.	through study Phase 1 completion, an average of 1 year
Primary	PHASE II: To quantify the effective reduction in SCE requests after the validated score is made available on the SCE prescription vouchers.	The main judgment criterion is the prescription of an irrelevant whole-body scanner (a patient whose 15 safety criteria are validated).	through study Phase 2 completion, an average of 1 year