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NCT04548596 · ClinicalTrials.gov registry record
NOninVasive Intracranial prEssure From Transcranial doppLer Ultrasound Development of a Comprehensive Database of Multimodality Monitoring Signals for Brain-Injured Patients
A clinical trial, sponsored by Emory University.
- Completed
- Registry status
- 162
- Enrollment target
NCT04548596: Completed study, sponsored by Emory University.
NCT04548596 is a clinical trial that has completed, run by Emory University. The registered enrollment target is 162 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04548596 has completed, sponsored by Emory University.
- COMPLETED
- Registry status
- 162 participants
- Enrollment target
Study 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), 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.
Primary Outcome
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.
Interventions
- DIAGNOSTIC_TEST Transcranial Doppler
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 162 participants |
| Start Date | 2014-09-10 |
| Est. Completion | 2025-04-30 |
What the finished NCT04548596 record still lists
NCT04548596 is an observational study that tracks outcomes without assigning an intervention. The registered 162 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 1 intervention - of which Transcranial Doppler is the first listed.
NCT04548596 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04548596 about?
NCT04548596 is a clinical study titled "NOninVasive Intracranial prEssure From Transcranial doppLer Ultrasound Development of a Comprehensive Database of Multimodality Monitoring Signals for Brain-Injured Patients". 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 Do...
What is the current status of trial NCT04548596?
This trial is currently completed. The enrollment target is 162 participants. The study started on 2014-09-10. Estimated completion is 2025-04-30.
What interventions are being tested in trial NCT04548596?
The interventions under investigation include: Transcranial Doppler (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT04548596?
This trial is sponsored by Emory University, which has 1,208 total clinical trials registered on ClinicalTrials.gov.
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