Confounding Factors in the Detection of Intracranial Hemorrhage With the Infrascanner

East Limburg Hospital

Status: Completed

Conditions: Head Trauma; Brain Surgery; Ischemic Stroke; Intracranial Hemorrhage; Brain Tumor; Headache

Treatments: Device: Infrascanner

Study type: Interventional

Funder types: Other

Identifiers

NCT02809651

16/015U

Details and patient eligibility

About

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.

Full 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.

Enrollment: 89 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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89 participants in 6 patient groups

Ischemic stroke

Experimental group

Description:

patients suffering from ischemic stroke diagnosed by clinical examination and CT-scan

Treatment:

Device: Infrascanner

Brain tumor

Experimental group

Description:

patients diagnosed with a brain tumor diagnosed by clinical examination and CT-scan or MRI

Treatment:

Device: Infrascanner

Brain surgery

Experimental group

Description:

patients that have undergone brain surgery

Treatment:

Device: Infrascanner

Intracranial hemorrhage

Active Comparator group

Description:

patients with intracranial hemorrhage diagnosed by clinical examination and CT-scan

Treatment:

Device: Infrascanner

Headache

Experimental group

Description:

patients with headache complaints and a normal CT-scan of the brain

Treatment:

Device: Infrascanner

Headtrauma

Experimental group

Description:

patients with head trauma and a normal CT-scan of the brain

Treatment:

Device: Infrascanner