Comparison of Image Quality Between Ultra-low Dose (ULD) and Standard Dose CT Scans in Detecting Traumatic Brain Injury in the Emergency Room

NCT ID: NCT05210855

Last Updated: 2025-03-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

77 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-12

Study Completion Date

2023-10-19

Brief Summary

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Head trauma is a frequent reason for consultation in the emergency room. The CT scan is the reference examination allowing rapid management of the patient. However, CT examinations are among the diagnostic examinations with the highest exposure to ionizing radiation. The study investigators have previously implemented "ultra-low dose" (ULD) acquisitions for several pathologies with an effective dose level similar to that of a standard radiographic examination. These ULD acquisitions are now routinely used in our clinical practice for explorations of the thorax, spine, pelvis and proximal femurs, extremities.

This study expands these ULD acquisitions to skull CT for detecting traumatic intracranial lesions.

The study investigators hypothesize that it would be possible to search for intracranial lesions in patients with head trauma using ULD protocols, thereby reducing the doses delivered to the patient while maintaining sufficient image quality for the diagnosis.

Detailed Description

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Conditions

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Closed Head Injury Penetrating Head Injury

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Patients with head trauma

Group Type EXPERIMENTAL

CT scan

Intervention Type DIAGNOSTIC_TEST

Scan with classic dose followed by ultra-low dose

Interventions

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CT scan

Scan with classic dose followed by ultra-low dose

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Patient presenting to the emergency room of the CHU of Nîmes for a cranial trauma requiring scanning.
* Patient with isolated head injury or polytrauma patient with head injury among others.
* The patient or their legal representative or family member must have given their free and informed consent and signed the consent form, or the patient was included under an emergency situation
* The patient must be a member or beneficiary of a health insurance plan

Exclusion Criteria

* The subject is participating in a study prohibiting participation in other studies, or is in a period of exclusion determined by a previous study
* Patient is pregnant, parturient or breastfeeding
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire de Nīmes

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Nicolas Menjot de Champfleur

Role: PRINCIPAL_INVESTIGATOR

CHU Nimes

Locations

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CHU de Nimes

Nîmes, , France

Site Status

Countries

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France

Other Identifiers

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NIMAO/2020-1/NM-02

Identifier Type: -

Identifier Source: org_study_id

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