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Completed

NCT Number: NCT05210855

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

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.

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Key information

Conditions

Closed Head Injury Craniocerebral Trauma Head Injuries, Closed Head Injuries, Penetrating Nervous System Diseases Penetrating Head Injury Trauma, Nervous System Wounds and Injuries Wounds, Nonpenetrating Wounds, Penetrating

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Nimes

Nîmes, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CT Scan

Diagnostic Test

Scan with classic dose followed by ultra-low dose

Primary outcomes

  1. Image quality of ultra-low dose scan compared to classic dose for visualising the differentiation of grey/white matter

    Time frame: Day 0

    5-point scale: unacceptable, sub-optimal, acceptable, better than average

  2. Image quality of ultra-low dose scan compared to classic dose for visualising lenticular nuclei

    Time frame: Day 0

    5-point scale: unacceptable, sub-optimal, acceptable, better than average

  3. Image quality of ultra-low dose scan compared to classic dose for visualising the ventricular system

    Time frame: Day 0

    5-point scale: unacceptable, sub-optimal, acceptable, better than average

  4. Image quality of ultra-low dose scan compared to classic dose for visualising basal cisterns

    Time frame: Day 0

    5-point scale: unacceptable, sub-optimal, acceptable, better than average

  5. Image quality of ultra-low dose scan compared to classic dose for visualising deconvexed subarachnoid spaces

    Time frame: Day 0

    5-point scale: unacceptable, sub-optimal, acceptable, better than average

Secondary outcomes

  1. 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)

    Time frame: Day 0

    Total score of the 5 Likert scores

  2. Presence of at least one extradural hematoma by ultra-low dose versus classical scanner

    Time frame: Day 0

    Yes/no

  3. Presence of at least one subarachnoid hemorrhage by ultra-low dose versus classical scanner

    Time frame: Day 0

    Yes/no

  4. Presence of at least one subdural hematoma by ultra-low dose versus classical scanner

    Time frame: Day 0

    Yes/no

  5. Presence of at least one intraparenchymal hemorrhage by ultra-low dose versus classical scanner

    Time frame: Day 0

    Yes/no

  6. Presence of at least one intracranial hemorrhage by ultra-low dose versus classical scanner

    Time frame: Day 0

    Yes/no

  7. Presence of at least one cranial bone lesion by ultra-low dose versus classical scanner

    Time frame: Day 0

    Yes/no

  8. Presence of at least one bone lesion by ultra-low dose versus classical scanner

    Time frame: Day 0

    Yes/no

  9. Radiologist-reported image quality of ultra-low dose versus classical scanner

    Time frame: 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

  10. Radiologist-reported diagnostic quality of ultra-low dose versus classical scanner

    Time frame: Day 0

    4-point Likert scale: unacceptable, sub-optimal, acceptable, better than average

  11. Radiologist-reported confidence level of ultra-low dose versus classical scanner

    Time frame: Day 0

    4-point Likert scale: unacceptable, sub-optimal, acceptable, better than average

  12. Interpretation time of ultra-low dose versus classical scanner for a senior and junior evaluator

    Time frame: Day 0

    Minutes

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nīmes

Other

Registry information

Acronym: ULD-CRANE 2

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jan 27, 2022
Registry last updated
Mar 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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