Confounding Factors in the Detection of Intracranial Hemorrhage With the Infrascanner

Not yet recruiting

Phase 4 Results N/A

Trial Description

The investigators prospectively want to use the Infrascanner in patients with ischemic stroke, patients with brain surgery, patients with brain tumors, patients with intracranial hemorrhage and patients with a normal CT scan of the brain as part of a diagnostic work-up after head trauma or headache to determine to positive and negative predictive value of the Infrascanner in these different settings.

Detailed Description

Infrascanner is a portable device initially designed to detect intracranial hemorrhage in battlefield traumas. Infrascanner uses near infrared spectroscopy to measure cerebral blood flow non-invasively. This is achieved by putting the device against the scalp in 4 different areas (frontal, temporal, parietal, occipital) on the left and right side and by comparing both sides.This allows for the detection of intracranial hemorrhages with a volume upwards of 3.5ml and to a depth of 2.5cm. However, little is known about the influence of other intracranial conditions that could confound the measurements of the Infrascanner (e.g. ischemic stroke, brain surgery, brain tumors,...).
Therefore, the investigators prospectively want to use the Infrascanner in patients with ischemic stroke, patients with brain surgery, patients with brain tumors, patients with intracranial hemorrhage and patients with a normal CT scan of the brain as part of a diagnostic work-up after head trauma or headache to determine the positive and negative predictive value of the Infrascanner in these different settings.

Conditions

Interventions

  • Infrascanner Device
    Intervention Desc: bilateral measurement cerebral blood flow with near infrared spectroscopy using the Infrascanner on the frontal, temporal, parietal and occipital region of the head.
    ARM 1: Kind: Experimental
    Label: Ischemic stroke
    Description: patients suffering from ischemic stroke diagnosed by clinical examination and CT-scan
    ARM 2: Kind: Experimental
    Label: Brain tumor
    Description: patients diagnosed with a brain tumor diagnosed by clinical examination and CT-scan or MRI
    ARM 3: Kind: Experimental
    Label: Brain surgery
    Description: patients that have undergone brain surgery
    ARM 4: Kind: Experimental
    Label: Intracranial hemorrhage
    Description: patients with intracranial hemorrhage diagnosed by clinical examination and CT-scan
    ARM 5: Kind: Experimental
    Label: Headache
    Description: patients with headache complaints and a normal CT-scan of the brain
    ARM 6: Kind: Experimental
    Label: Headtrauma
    Description: patients with head trauma and a normal CT-scan of the brain

Trial Design

  • Allocation: Non-Randomized
  • Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
  • Purpose: Diagnostic
  • Endpoint: Efficacy Study
  • Intervention: Parallel Assignment
  • Observation: Cohort
  • Perspective: Prospective

Outcomes

Type Measure Time Frame Safety Issue
Primary Presence of intracranial hemorrhage as indicated by the Infrascanner compared to the result of the CT-scan (gold standard) 5 minutes No

Sponsors