Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
estimated completion

Description

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.

Keywords

Traumatic Brain Injury Subarachnoid Hemorrhage Intracerebral Hemorrhage Liver Failure Ischemic Stroke Brain Injuries Brain Injuries, Traumatic Cerebral Hemorrhage Hemorrhage Transcranial Doppler

Eligibility

You can join if…

Open to people ages 18 years and up

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

You CAN'T join if...

  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 middle cerebral artery (MCA)
  3. Subjects that have skull fractures that the attending or study investigators believe participation would add clinical risk to the subject
  4. Subjects that had hemicraniectomy and are still without bone flap

Locations

  • University of California San Francisco accepting new patients
    San Francisco California United States
  • Duke University not yet accepting patients
    Durham North Carolina United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Duke University
ID
NCT04548596
Study Type
Observational
Last Updated