NCT02809651

Confounding Factors in the Detection of Intracranial Hemorrhage With the Infrascanner

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 89 (actual)
• Sponsor: Ziekenhuis Oost-Limburg · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

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

• Ischemic Stroke
• Brain Tumor
• Brain Surgery
• Intracranial Hemorrhage
• Headache
• Head Trauma

Interventions

Type	Name	Description
DEVICE	Infrascanner	bilateral measurement cerebral blood flow with near infrared spectroscopy using the Infrascanner on the frontal, temporal, parietal and occipital region of the head.

Timeline

• Start date: 2016-08-01
• Primary completion: 2017-02-01
• Completion: 2017-02-01
• First posted: 2016-06-22
• Last updated: 2017-03-14

Locations

1 site across 1 country: Belgium