Non-Invasive Monitoring of Traumatic Brain Injury Progression Using the Infrascanner (MOBI-1)

Summary

Participation Requirements

Description

MOBI-1 is a multi-center, randomized clinical trial, comparing standard care plus hourly infrascans, to standard care alone. Patients will be randomized to either standard care Patients randomized to this arm of the study will receive regular clinical neurological assessments, at a frequency determi...

MOBI-1 is a multi-center, randomized clinical trial, comparing standard care plus hourly infrascans, to standard care alone. Patients will be randomized to either standard care Patients randomized to this arm of the study will receive regular clinical neurological assessments, at a frequency determined by the local standard of care. (Typically hourly.) Clinical neurological assessments consist of documentation of the patient's GCS, intracranial pressure (if an intracranial pressure monitoring device has been placed), examination for presence of focal neurological signs, and other vital signs. This process will be repeated until the second planned CT has been performed. If the patient's neurological status deteriorates at any time point, and the medical team orders an early (unplanned) CT scan, the neurological data collection will cease once the patient is sent to CT: or standard care plus infrascans The Infrascanner is a hand-held, non-invasive device, which is FDA-cleared to detect traumatic intracranial hematomas. MOBI-1 aims to expand the utility of the device by evaluating its ability to serially monitor patients with intracranial hematomas, following the initial detection with CT, to detect expansion prior to the observance of clinical signs of neurological deterioration. Use of the infrascanner will be in addition to standard care. Patients enrolled in this arm will receive the same neurological assessment (GCS, focal neurological signs, vital signs) as patients in the standard care arm. In addition, a research team member will perform an infrascan. This process will be repeated until the second planned CT has been performed.

Tracking Information