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

NCT05588791 | Recruiting

• 1 other identifier: 2020/0425/HP
• Study Type: observational
• Target: 2,018
• Locations: 1 country
• Sites: 1

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.

Conditions

Trauma

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Interventions

whole-body computed tomography DIAGNOSTIC_TEST

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• University Hospital, Rouen: lead

Study Sites (1)

Services des Urgences Adultes

Rouen, 76031, France

RECRUITING

MeSH Terms

Conditions

Wounds and Injuries

Central Study Contacts

David MALLET

CONTACT

0033 2 32 88 82 65; secretariat.DRC@chu-rouen.fr

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 14, 2022
• First Posted: October 20, 2022
• Study Start: June 23, 2023
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: October 8, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)