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

  • STATUS
    Recruiting
  • End date
    Nov 30, 2023
  • participants needed
    432
  • sponsor
    Duke University
Updated on 10 November 2021
stroke
traumatic brain injury

Summary

This is an observational study in neurocritical care units at University of California San Francisco Medical Center (UCSFMC), Zuckerberg San Francisco General Hospital (ZSFGH), and Duke University Medical Center. 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.

Details
Condition Subarachnoid Hemorrhage, Hepatic Failure, Traumatic Brain Injury, cerebral bleeding, Brain Injury, Ischemic Stroke, hemorrhage cerebral, intracerebral hemorrhage (ich), intracerebral hemorrhage, Liver Failure, Cerebral Hemorrhage, Brain Injuries, Traumatic, intracerebral haemorrhage, traumatic brain injury (tbi), Hepatic Insufficiency
Treatment transcranial Doppler
Clinical Study IdentifierNCT04548596
SponsorDuke University
Last Modified on10 November 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Male or female subjects 18 years of age and older
Subjects who have an ICP monitoring device that allows for 30 minutes of continuous monitoring

Exclusion Criteria

Unstable medical illness such as recordings might interfere with medical care
Subjects that don't have a viable temporal window to insonate the middle cerebral artery (MCA)
Subjects that have skull fractures that the attending or study investigators believe participation would add clinical risk to the subject
Subjects that had hemicraniectomy and are still without bone flap
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