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

Not Applicable

Completed

• Conditions: Penetrating Head Injury; Closed Head Injury
• Interventions: Diagnostic Test: CT scan

• Registration Number: NCT05210855
• Lead Sponsor: Centre Hospitalier Universitaire de Nīmes

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-01-14
• Study First Submitted QC: 2022-01-14
• Study First Posted: 2022-01-27
• Study Start: 2022-05-12
• Primary Completion: 2023-10-19
• Study Completion: 2023-10-19
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-07
• Last Update Posted: 2025-03-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 77

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients with head trauma	CT scan	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Presence of at least one subdural hematoma by ultra-low dose versus classical scanner	Day 0	Yes/no
Radiologist-reported diagnostic quality of ultra-low dose versus classical scanner	Day 0	4-point Likert scale: unacceptable, sub-optimal, acceptable, better than average
Presence of at least one cranial bone lesion by ultra-low dose versus classical scanner	Day 0	Yes/no
Interpretation time of ultra-low dose versus classical scanner for a senior and junior evaluator	Day 0	Minutes
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)	Day 0	Total score of the 5 Likert scores
Presence of at least one intraparenchymal hemorrhage by ultra-low dose versus classical scanner	Day 0	Yes/no
Radiologist-reported image quality of ultra-low dose versus classical scanner	Day 0	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
Presence of at least one subarachnoid hemorrhage by ultra-low dose versus classical scanner	Day 0	Yes/no
Presence of at least one extradural hematoma by ultra-low dose versus classical scanner	Day 0	Yes/no
Presence of at least one bone lesion by ultra-low dose versus classical scanner	Day 0	Yes/no
Presence of at least one intracranial hemorrhage by ultra-low dose versus classical scanner	Day 0	Yes/no
Radiologist-reported confidence level of ultra-low dose versus classical scanner	Day 0	4-point Likert scale: unacceptable, sub-optimal, acceptable, better than average

Trial Locations

Locations (1)

CHU de Nimes; 🇫🇷 Nîmes, France