Clinical trial NCT05210855: Comparison of Image Quality Between Ultra-low Dose (ULD) and Standard Dose CT Scans in Detecting Traumatic Brain Injury in the Emergency Room
Official title: Comparison of Image Quality Between Ultra-low Dose (ULD) and Standard Dose CT Scans in Detecting Traumatic Brain Injury in the Emergency Room
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Closed Head Injury
Penetrating Head Injury
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2022-01-27
Enrollment: 77
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Image quality of ultra-low dose scan compared to classic dose for visualising the differentiation of grey/white matter
timeFrame: Day 0
measure: Image quality of ultra-low dose scan compared to classic dose for visualising lenticular nuclei
timeFrame: Day 0
measure: Image quality of ultra-low dose scan compared to classic dose for visualising the ventricular system
timeFrame: Day 0
measure: Image quality of ultra-low dose scan compared to classic dose for visualising basal cisterns
timeFrame: Day 0
measure: Image quality of ultra-low dose scan compared to classic dose for visualising deconvexed subarachnoid spaces
timeFrame: Day 0
Secondary outcomes:
measure: Inter-evaluator concordance (senior versus junior) in visualizing all five structures (differentiation of grey/white matter, lenticular nuclei, ventricular system, basal cisterns, deconvexed subarachnoid spaces)
timeFrame: Day 0
measure: Presence of at least one extradural hematoma by ultra-low dose versus classical scanner
timeFrame: Day 0
measure: Presence of at least one subarachnoid hemorrhage by ultra-low dose versus classical scanner
timeFrame: Day 0
measure: Presence of at least one subdural hematoma by ultra-low dose versus classical scanner
timeFrame: Day 0
measure: Presence of at least one intraparenchymal hemorrhage by ultra-low dose versus classical scanner
timeFrame: Day 0
measure: Presence of at least one intracranial hemorrhage by ultra-low dose versus classical scanner
timeFrame: Day 0
measure: Presence of at least one cranial bone lesion by ultra-low dose versus classical scanner
timeFrame: Day 0
measure: Presence of at least one bone lesion by ultra-low dose versus classical scanner
timeFrame: Day 0
measure: Radiologist-reported image quality of ultra-low dose versus classical scanner
timeFrame: Day 0
measure: Radiologist-reported diagnostic quality of ultra-low dose versus classical scanner
timeFrame: Day 0
measure: Radiologist-reported confidence level of ultra-low dose versus classical scanner
timeFrame: Day 0
measure: Interpretation time of ultra-low dose versus classical scanner for a senior and junior evaluator
timeFrame: Day 0
Other outcomes:
Locations:
city: Nîmes
country: France
facility: CHU de Nimes
Study officials:
affiliation: CHU Nimes
name: Nicolas Menjot de Champfleur
role: PRINCIPAL_INVESTIGATOR
References: