Neuromonitoring for Hypoxic-Ischemic Brain Injury
(DIFFUSION Trial)
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of British Columbia
Must not be taking: Anticoagulants, Antiplatelets
Disqualifiers: Coagulopathy, Severe TBI, Stroke, others
No Placebo Group
Approved in 3 Jurisdictions
Trial Summary
What is the purpose of this trial?This trial evaluates how well oxygen gets from the blood into the brain in patients who have had a cardiac arrest. It focuses on patients with brain injury due to lack of oxygen, checking both blood flow and oxygen movement into brain cells, as well as looking at markers for brain injury and inflammation.
Will I have to stop taking my current medications?
The trial excludes participants who are currently using or are expected to use anticoagulant or antiplatelet medications, so you would need to stop these medications to participate.
What data supports the effectiveness of the treatment Neuromonitoring for Hypoxic-Ischemic Brain Injury?
Research shows that neuromonitoring can help detect early changes in brain function, allowing for timely treatment to prevent further brain damage. Techniques like intracranial pressure monitoring and EEG are used to monitor brain health in critical care, which can improve outcomes in patients with brain injuries.
12345Is neuromonitoring safe for humans?
Noninvasive neuromonitoring methods are generally considered safe, with advantages like lower risk of infection and bleeding compared to invasive methods. These techniques are used in various conditions, including brain injuries and neonatal care, to monitor brain function and oxygen levels.
23678How is the treatment Neuromonitoring different from other treatments for hypoxic-ischemic brain injury?
Neuromonitoring is unique because it involves continuous observation of brain functions using techniques like intracranial pressure measurement and EEG monitoring, which help detect subtle changes in brain physiology early. Unlike other treatments, it focuses on real-time monitoring to prevent further brain damage by providing immediate data that can guide therapeutic decisions.
135910Eligibility Criteria
This trial is for adults over 19 who've had a cardiac arrest lasting more than 10 minutes and are in a coma or have severe brain function impairment. They must be able to receive invasive monitoring within 72 hours of the event. People with blood clotting issues, on certain blood thinners, or with past severe brain injuries or strokes can't participate.Inclusion Criteria
I am over 19 and have a low consciousness level after a cardiac arrest.
I had heart monitoring started within 3 days after a cardiac arrest.
My heart has stopped for more than 10 minutes before.
Exclusion Criteria
I am currently using or plan to use blood thinners.
Your blood doesn't clot normally, or you have low platelet levels.
I have had a severe brain injury, bleeding in the brain, or a stroke.
+1 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
1-2 weeks
Neuromonitoring
Neuromonitoring is placed after cardiac arrest, and various evaluations are conducted including blood gas analysis and microdialysis measures.
3 days
Continuous monitoring
Follow-up
Participants are monitored for clinical outcomes, including cerebral performance category, at 6 months post-arrest.
6 months
Participant Groups
The study aims to understand why some patients can't get enough oxygen into their brains after a cardiac arrest by using advanced neuromonitoring techniques. It will compare those with normal and abnormal oxygen transport to find out what's causing these differences.
1Treatment groups
Experimental Treatment
Group I: Neuromonitoring armExperimental Treatment1 Intervention
Neuromonitoring placed after cardiac arrest
Neuromonitoring is already approved in United States, European Union, Canada for the following indications:
🇺🇸 Approved in United States as Neuromonitoring for:
- Monitoring of intracranial pressure and cerebral perfusion in critically ill patients
- Diagnosis and management of seizures and status epilepticus
- Assessment of brain death
🇪🇺 Approved in European Union as Neuromonitoring for:
- Monitoring of brain function in patients with traumatic brain injury
- Diagnosis and management of cerebral vasospasm
- Assessment of cerebral autoregulation
🇨🇦 Approved in Canada as Neuromonitoring for:
- Monitoring of intracranial pressure and cerebral perfusion in critically ill patients
- Diagnosis and management of seizures and status epilepticus
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Vancouver General HospitalVancouver, Canada
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Who Is Running the Clinical Trial?
University of British ColumbiaLead Sponsor
References
[Multimodal Neuromonitoring and its Impact on Therapeutic and Diagnostic Decisions in Critical Ill Patients]. [2019]Patients with acute cerebral injuries for various reasons (traumatic, ischemic, hemorrhagic) are at risc for developing secondary brain damage and further neurological deterioration. The aim of neuromonitoring is to recognize subtile changes in intracranial physiology as early as possible to initiate adequate diagnostic and therapeutic measures to prevent secondary brain damage. Beside the classic method of clinical neuromonitoring in awake patients, implantation of intracranial probes to monitor intracranial pressure, brain tissue oxygenation and brain metabolism are used in comatose patients. Electrophysiological monitoring by electrocorticography or evoked potentials and measurement of cerebral blood flow provide additional information.The indications and clinical impact of these various monitoring techniques are discussed to ensure optimal medical care in patients with acute brain injury.
Noninvasive Neuromonitoring: Current Utility in Subarachnoid Hemorrhage, Traumatic Brain Injury, and Stroke. [2018]Noninvasive neuromonitoring is increasingly being used to monitor the course of primary brain injury and limit secondary brain damage of patients in the neurocritical care unit. Proposed advantages over invasive neuromonitoring methods include a lower risk of infection and bleeding, no need for surgical installation, mobility and portability of some devices, and safety. The question, however, is whether noninvasive neuromonitoring is practical and trustworthy enough already. We searched the recent literature and reviewed English-language studies on noninvasive neuromonitoring in subarachnoid hemorrhage, traumatic brain injury, and ischemic and hemorrhagic stroke between the years 2010 and 2015. We found 88 studies that were eligible for review including the methods transcranial ultrasound, electroencephalography, evoked potentials, near-infrared spectroscopy, bispectral index, and pupillometry. Noninvasive neuromonitoring cannot yet completely replace invasive methods in most situations, but has great potential being complementarily integrated into multimodality monitoring, for guiding management, and for limiting the use of invasive devices and in-hospital transports for imaging.
Neuromonitoring. [2019]Neuromonitoring--the continuous or intermittent observation of nervous system functions--has become a field of interdisciplinary interest. Basically there are two major applications of neuromonitoring: in the operating theatre and the neurological or neurosurgical intensive care unit. Evoked potential recording, intracranial pressure measurement, serial EEG recording, cerebral blood flow measurement and ultrasound techniques have all been used as monitoring methods. The application of these techniques for operations, intensive care and the evaluation of brain death will be described.
Brain perfusion and oxygenation. [2014]Maintenance of brain perfusion and oxygenation is of paramount importance to patient outcome with various types of brain injuries (traumatic, ischemic, and hemorrhagic). Historically, monitoring of intracranial pressure and cerebral perfusion pressure has been the mainstay of neuromonitoring techniques used at the critical care bedside to monitor brain perfusion and oxygenation. This article describes the bedside neuromonitoring techniques that have emerged for use with these patients in the critical care area. To give the reader an understanding of the functionality of these neuromonitoring techniques, the article first summarizes the physiology of brain perfusion and oxygenation.
Brain monitoring after cardiac arrest. [2023]To describe the available neuromonitoring tools in patients who are comatose after resuscitation from cardiac arrest because of hypoxic-ischemic brain injury (HIBI).
A Survey of Neuromonitoring Practices in North American Pediatric Intensive Care Units. [2023]Neuromonitoring is the use of continuous measures of brain physiology to detect clinically important events in real-time. Neuromonitoring devices can be invasive or non-invasive and are typically used on patients with acute brain injury or at high risk for brain injury. The goal of this study was to characterize neuromonitoring infrastructure and practices in North American pediatric intensive care units (PICUs).
Bedside and laboratory neuromonitoring in neonatal encephalopathy. [2022]Several bedside and laboratory neuromonitoring tools are currently used in neonatal encephalopathy (NE) to assess 1) brain function [amplitude-integrated electroencephalogram (aEEG) and EEG], 2) cerebral oxygenation delivery and consumption [near-infrared spectroscopy (NIRS)] and 3) blood and cerebrospinal fluid biomarkers. The aim of the review is to provide the role of neuromonitoring in understanding the development of brain injury in these newborns and better predict their long-term outcome. Simultaneous use of these monitoring modalities may improve our ability to provide meaningful prognostic information regarding ongoing treatments. Evidence will be summarized in this review for each of these modalities, by describing (1) the methods, (2) the clinical evidence in context of NE both before and with hypothermia, and (3) the research and future directions.
Optimal neuromonitoring techniques in neonates with hypoxic ischemic encephalopathy. [2023]Neonates with hypoxic ischemic encephalopathy (HIE) are at significant risk for adverse outcomes including death and neurodevelopmental impairment. Neuromonitoring provides critical diagnostic and prognostic information for these infants. Modalities providing continuous monitoring include continuous electroencephalography (cEEG), amplitude-integrated electroencephalography (aEEG), near-infrared spectroscopy (NIRS), and heart rate variability. Serial bedside neuromonitoring techniques include cranial ultrasound and somatic and visual evoked potentials but may be limited by discrete time points of assessment. EEG, aEEG, and NIRS provide distinct and complementary information about cerebral function and oxygen utilization. Integrated use of these neuromonitoring modalities in addition to other potential techniques such as heart rate variability may best predict imaging outcomes and longer-term neurodevelopment. This review examines available bedside neuromonitoring techniques for the neonate with HIE in the context of therapeutic hypothermia.
Brain tissue oxygenation monitoring in acute brain injury. [2019]Cerebral ischemia is one of the most important causes of secondary insults following acute brain injury. While intracranial pressure monitoring in the intensive care unit constitutes the cornerstone of neurocritical care monitoring, it does not reflect the state of oxygenation of the injured brain. The holy grail of neuromonitoring is a modality that would reflect accurately real time the status of oxygenation in the tissue of interest, is robust, artefact free and that which provides information that can be used for therapeutic interventions and to improve outcome. Such a device could conceivably be used to augment the sensitivity of current multi-modality monitoring systems in the neurocritical management of brain injured patients. This article examines the availability of data in the literature to support clinical use of local tissue oxygen probes in intensive care.
Monitoring for neuroprotection. New technologies for the new millennium. [2004]Monitoring for neuroprotection, like surgery, has placed on emphasis on minimal or non-invasiveness. Monitoring of parameters that truly reflect the degree of injury to the nervous system is another goal. Thus, two themes for the coming decade in neuromonitoring will be: (1) less-invasive monitoring; and (2) parameters that more closely reflect the etiological factors in ischemic or other neuroinjury. In this paper, we review neuromonitoring techniques and devices that can be used readily in the operating room or intensive care unit setting. Those that require transport of the patient to a special facility (e.g., for computed tomography or magnetic resonance imaging/spectroscopy) and those that have been in standard practice for neuromonitoring (e.g., electrophysiological monitoring--EEG, evoked potentials) are not considered. The two techniques considered in detail are (1) continuous multiparameter local brain tissue monitoring with microprobes, and (2) non-invasive continuous local brain tissue oxygenation monitoring by near infrared spectroscopy. Both techniques have been cleared by the Food and Drug Administration (FDA) for clinical use. The rationale for their use, the nature of the devices, and clinical results to date are reviewed. It is expected that both techniques will gain wide acceptance during the coming decade; further advances in neuromonitoring that can be expected further into the twenty-first century are also discussed.