Augmented Multimodal Neurologic Monitoring in High Risk Survivors of Cardiac Arrest

Study Overview
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Brief Summary
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Cardiac arrest is the most common cause of death in the United States and as many as 590,000 Americans suffering a cardiac arrest each year. Despite advances in care, as many as 50 to 89% of patients who are resuscitated after a cardiac arrest die in the hospital. Brain injury is the most common cause of death and disability after cardiac arrest. The investigators use advanced brain monitoring in patients who are at high risk of death after cardiac arrest, with the goal of preventing ongoing brain injury. The most common problem the investigators have observed is low oxygen levels in the brain, which is often very difficult to treat. In this study, the investigators plan to use two additional brain monitors in the care of these high risk patients: a monitor for seizures and a monitor of the amount of blood flow in the brain. The investigators will use these to detect and treat potential causes of low brain oxygen levels. The main hypotheses are that electrical events in the brain such as seizures and spreading depolarizations will occur during times of low brain tissue oxygen level, and that treating these events and low blood flow will reduce the rate of low brain oxygen levels.

Official Title
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Augmented Multimodal Neurologic Monitoring in High Risk Survivors of Cardiac Arrest

Conditions
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Cardiac Arrest

Intervention / Treatment
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* Device: QFlow 500™ Perfusion Probe (Hemedex, Cambridge, MA)
* Device: Spencer Probe Depth Electrode (Ad-Tech Medical, Racine, WI)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: High risk survivors of cardiac arrest Decision by potential subject's clinical team to use our institutional standard invasive, multimodal neurologic monitoring for post-arrest care Exclusion Criteria: None

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cardiac arrest<br>Survivors of cardiac arrest at high risk of neurological deterioration. Participants will undergo placement of a Spencer Probe Depth Electrode and QFlow 500™ Perfusion Probe in addition to the institutional standard multimodal neurological monitoring. | Device: QFlow 500™ Perfusion Probe (Hemedex, Cambridge, MA)<br> <br> Device: Spencer Probe Depth Electrode (Ad-Tech Medical, Racine, WI)<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Spreading Depolarizations |  | Participants will be followed for the duration of invasive monitoring, an expected average of 5 days | 
| Occult Seizures | Seizures detected by intracortical EEG but not surface EEG | Participants will be followed for the duration of invasive monitoring, an expected average of 5 days | 
| Cerebral Hypoperfusion |  | Participants will be followed for the duration of invasive monitoring, an expected average of 5 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinically Significant Bleeding |  | Participants will be followed for the duration of the initial hospitalization, an expected average of 2 weeks | 
| Monitor-associated Infection |  | Participants will be followed for the duration of the initial hospitalization, an expected average of 2 weeks | 
| Device Malfunction |  | Participants will be followed for the duration of invasive monitoring, an expected average of 5 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cardiac arrest, Neurological injury, Seizures, Spreading depolarizations, Cerebral hypoperfusion, Brain tissue hypoxia