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NCT Number: NCT05588791

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

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.

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Key information

Conditions

Trauma Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Services des Urgences Adultes

Rouen, 76031, France

Location status: Recruiting

Location contact

Mehdi MI TAALBA, Dr

CONTACT

[email protected]

(0)2 32 88 66 87 ext. +33

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

whole-body computed tomography

Diagnostic Test

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

Primary outcomes

  1. 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

    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.

  2. 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

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

Study contacts

Contact information is provided by the study sponsor or research team.

David MALLET

CONTACT

[email protected]

0033 2 32 88 82 65

Sponsors and collaborators

Lead sponsor

University Hospital, Rouen

Other

Registry information

Official study title

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

Acronym: PRE-SCEAU

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Oct 20, 2022
Registry last updated
Oct 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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