NOninVasive Intracranial prEssure From Transcranial doppLer Ultrasound Development of a Comprehensive Database of Multimodality Monitoring Signals for Brain-Injured Patients (NOVEL ICP)

Emory University

Status: Completed

Conditions: Subarachnoid Hemorrhage; Ischemic Stroke; Traumatic Brain Injury; Liver Failure; Intracerebral Hemorrhage

Treatments: Diagnostic Test: Transcranial Doppler

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT04548596

R01NS106905 (U.S. NIH Grant/Contract)

STUDY00004039

Pro00105151

Details and patient eligibility

About

This is an observational study in neurocritical care units at University of California San Francisco Medical Center (UCSFMC), Zuckerberg San Francisco General Hospital (ZSFGH), UC Davis, and Emory University. In this study, the investigators will primarily use the monitor mode of the Transcranial Doppler (TCD, non-invasive FDA approved device) to record cerebral blood flow velocity (CBFV) signals from the Middle Cerebral Artery and Internal Carotid Artery. TCD data and intracranial pressure (ICP) data will be collected in the following four scenarios. Each recording is up to 60 minutes in length.

Multimodality high-resolution physiological signals will be collected from brain injured patients: traumatic brain injury, subarachnoid and intracerebral hemorrhage, liver failure, and ischemic stroke. This is not a hypothesis-driven study but rather a signal database development project with a goal to collect multimodality brain monitoring data to support development and validation of algorithms that will be useful for future brain monitoring devices. In particular, the collected data will be used to support:

Development and validation of noninvasive intracranial pressure (nICP) algorithms.

Development and validation of continuous monitoring of neurovascular coupling state for brain injury patients

Development and validation of noninvasive approaches of detecting elevated ICP state.

Development and validation of approaches to determine most likely causes of ICP elevation.

Development and validation of approaches to detect acute cerebral hemodynamic response to various neurovascular procedures.

Enrollment: 162 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Male or female subjects 18 years of age and older
2. Subjects who have an ICP Monitoring device

Exclusion criteria

1. Unstable medical illness such as recordings might interfere with medical care.
2. Subjects that don't have a viable temporal window to insonate the MCA.
3. Subjects that have skull fractures that the attending or study investigators believe participation would add clinical risk to the subject.

Trial design