Confounding Factors in the Detection of Intracranial Hemorrhage With the Infrascanner

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Prospective Study to Determine Confounding Factors in the Detection of Intracranial Hemorrhage With the Infrascanner

Conditions
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Ischemic Stroke, Brain Tumor, Brain Surgery, Intracranial Hemorrhage, Headache, Head Trauma

Intervention / Treatment
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* Device: Infrascanner


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with ischemic stroke diagnosed by clinical examination and CT-scan Patients with a brain tumor diagnosed by clinical examination and CT-scan or MRI Patients with an intracranial hemorrhage diagnosed by clinical examination and CT-scan Patients that have undergone brain surgery Patients with a normal CT-scan of the brain after head trauma Patients with headache complaints and a normal CT-scan of the brain as part of their diagnostic work-up Exclusion Criteria: none
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
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ischemic stroke<br>patients suffering from ischemic stroke diagnosed by clinical examination and CT-scan | Device: Infrascanner<br>* bilateral measurement cerebral blood flow with near infrared spectroscopy using the Infrascanner on the frontal, temporal, parietal and occipital region of the head.<br>|
| Experimental: Brain tumor<br>patients diagnosed with a brain tumor diagnosed by clinical examination and CT-scan or MRI | Device: Infrascanner<br>* bilateral measurement cerebral blood flow with near infrared spectroscopy using the Infrascanner on the frontal, temporal, parietal and occipital region of the head.<br>|
| Experimental: Brain surgery<br>patients that have undergone brain surgery | Device: Infrascanner<br>* bilateral measurement cerebral blood flow with near infrared spectroscopy using the Infrascanner on the frontal, temporal, parietal and occipital region of the head.<br>|
| Active Comparator: Intracranial hemorrhage<br>patients with intracranial hemorrhage diagnosed by clinical examination and CT-scan | Device: Infrascanner<br>* bilateral measurement cerebral blood flow with near infrared spectroscopy using the Infrascanner on the frontal, temporal, parietal and occipital region of the head.<br>|
| Experimental: Headache<br>patients with headache complaints and a normal CT-scan of the brain | Device: Infrascanner<br>* bilateral measurement cerebral blood flow with near infrared spectroscopy using the Infrascanner on the frontal, temporal, parietal and occipital region of the head.<br>|
| Experimental: Headtrauma<br>patients with head trauma and a normal CT-scan of the brain | Device: Infrascanner<br>* bilateral measurement cerebral blood flow with near infrared spectroscopy using the Infrascanner on the frontal, temporal, parietal and occipital region of the head.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Presence of intracranial hemorrhage as indicated by the Infrascanner compared to the result of the CT-scan (gold standard) |  | 5 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Infrascanner, Intracranial hemorrhage