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

Study Overview
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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.

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

Conditions
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Closed Head Injury, Penetrating Head Injury

Intervention / Treatment
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* Diagnostic Test: CT scan


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patients with head trauma<br> | Diagnostic Test: CT scan<br>* Scan with classic dose followed by ultra-low dose<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Image quality of ultra-low dose scan compared to classic dose for visualising the differentiation of grey/white matter | 5-point scale: unacceptable, sub-optimal, acceptable, better than average | Day 0 | 
| Image quality of ultra-low dose scan compared to classic dose for visualising lenticular nuclei | 5-point scale: unacceptable, sub-optimal, acceptable, better than average | Day 0 | 
| Image quality of ultra-low dose scan compared to classic dose for visualising the ventricular system | 5-point scale: unacceptable, sub-optimal, acceptable, better than average | Day 0 | 
| Image quality of ultra-low dose scan compared to classic dose for visualising basal cisterns | 5-point scale: unacceptable, sub-optimal, acceptable, better than average | Day 0 | 
| Image quality of ultra-low dose scan compared to classic dose for visualising deconvexed subarachnoid spaces | 5-point scale: unacceptable, sub-optimal, acceptable, better than average | Day 0 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | Total score of the 5 Likert scores | Day 0 | 
| Presence of at least one extradural hematoma by ultra-low dose versus classical scanner | Yes/no | Day 0 | 
| Presence of at least one subarachnoid hemorrhage by ultra-low dose versus classical scanner | Yes/no | Day 0 | 
| Presence of at least one subdural hematoma by ultra-low dose versus classical scanner | Yes/no | Day 0 | 
| Presence of at least one intraparenchymal hemorrhage by ultra-low dose versus classical scanner | Yes/no | Day 0 | 
| Presence of at least one intracranial hemorrhage by ultra-low dose versus classical scanner | Yes/no | Day 0 | 
| Presence of at least one cranial bone lesion by ultra-low dose versus classical scanner | Yes/no | Day 0 | 
| Presence of at least one bone lesion by ultra-low dose versus classical scanner | Yes/no | Day 0 | 
| Radiologist-reported image quality of ultra-low dose versus classical scanner | 4-point Likert scale: Interpretable, interpretable despite moderate technical issues (centering, movement, constant), entirely interpretable despite moderate technical issues (centering, movement, constant), No technical issues | Day 0 | 
| Radiologist-reported diagnostic quality of ultra-low dose versus classical scanner | 4-point Likert scale: unacceptable, sub-optimal, acceptable, better than average | Day 0 | 
| Radiologist-reported confidence level of ultra-low dose versus classical scanner | 4-point Likert scale: unacceptable, sub-optimal, acceptable, better than average | Day 0 | 
| Interpretation time of ultra-low dose versus classical scanner for a senior and junior evaluator | Minutes | Day 0 |