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

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ClinicalTrials.gov Identifier: NCT04548596
Recruitment Status : Recruiting
First Posted : September 14, 2020
Last Update Posted : September 14, 2020
Sponsor:
Collaborator:
University of California, San Francisco
Information provided by (Responsible Party):
Duke University

Brief 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.


Condition or disease Intervention/treatment
Traumatic Brain Injury Subarachnoid Hemorrhage Intracerebral Hemorrhage Liver Failure Ischemic Stroke Diagnostic Test: Transcranial Doppler

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Study Type : Observational
Estimated Enrollment : 432 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: NOninVasive Intracranial prEssure From Transcranial doppLer Ultrasound Development of a Comprehensive Database of Multimodality Monitoring Signals for Brain-Injured Patients
Actual Study Start Date : September 10, 2014
Estimated Primary Completion Date : November 30, 2023
Estimated Study Completion Date : November 30, 2023

Resource links provided by the National Library of Medicine



Intervention Details:
  • Diagnostic Test: Transcranial Doppler

    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:

    External ventricular drain (EVD) closed to drainage for a 24 hour period as part of the EVD weaning protocol per standard of care (SOC): The Initial reading will be done within 4 hours of EVD closing. The second reading will be done within 4 hours of anticipated removal of EVD.

    EVD closed most of the time and opened to drainage when the ICP becomes elevated per SOC

    EVD with Intra-Parenchymal fiber optical ICP sensor per SOC

    Intra-Parenchymal fiber optical ICP sensor per SOC



Primary Outcome Measures :
  1. Multimodality high-resolution signals from brain-injured patients [ Time Frame: at completion of the study up to 3 years ]
    The investigators aim to collect multimodality high-resolution physiological signals from brain-injured patients. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The investigators aim to collect multimodality high-resolution physiological signals from brain injured patients: traumatic brain injury, subarachnoid and intracerebral hemorrhage, liver failure, and ischemic stroke.
Criteria

Inclusion Criteria:

  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

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 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04548596


Contacts
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Contact: Megan Arthur 9196844025 megan.arthur@duke.edu
Contact: Xiao Hu xiao.hu@duke.edu

Locations
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United States, California
University of California San Francisco Recruiting
San Francisco, California, United States
Contact: Maximilian Vuong       maximilian.vuong@ucsf.edu   
United States, North Carolina
Duke University Not yet recruiting
Durham, North Carolina, United States
Contact: Megan Arthur    919-684-4025    megan.arthur@duke.edu   
Sponsors and Collaborators
Duke University
University of California, San Francisco
Investigators
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Principal Investigator: Xiao Hu Duke University
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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT04548596    
Other Study ID Numbers: Pro00105151
First Posted: September 14, 2020    Key Record Dates
Last Update Posted: September 14, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Liver Failure
Brain Injuries
Brain Injuries, Traumatic
Subarachnoid Hemorrhage
Cerebral Hemorrhage
Hemorrhage
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries
Pathologic Processes
Intracranial Hemorrhages
Cerebrovascular Disorders
Vascular Diseases
Cardiovascular Diseases
Hepatic Insufficiency
Liver Diseases
Digestive System Diseases