Augmented Multimodal Neurologic Monitoring in High Risk Survivors of Cardiac Arrest
Phase: NA
Conditions: Cardiac Arrest
Sponsor: Jonathan Elmer

Official title:  
 
Augmented Multimodal Neurologic Monitoring in High Risk Survivors of Cardiac Arrest 
 
NCT Number: NCT02069353  
 
Document date: 11/30/2018

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Trial Protocol 
PRIOR TO APPROACHING SURROGATE(S): The Post-Cardiac Arrest Service (PCAS) 
physician will have been consulted to evaluate and treat patients eligible to be subjects in 
this research study. They will have already made the decision to offer invasive multimodal 
neurological monitoring to the patient, and surrogate consent for this non-research clinical 
procedure will have been obtained. A study investigator will be contacted directly by the 
PCAS physician.  
 
Patient surrogate(s) currently provide procedural consent for invasive monitoring prior to 
ICU admission, since multimodal neurologic monitoring requires triage to a neuroscience 
ICU. We plan to approach potential research subjects after procedural consent is obtained 
but before the procedure is performed. This timing is necessary because, to ensure sterility, 
the monitoring probes are placed at the same time as the intracranial access bolt is placed 
(i.e. these steps are components of the same larger procedure). The eligibility requirements 
for invasive neurologic monitoring for CLINICAL purposes and participation as a subject in 
this RESEARCH proposal are identical, and no specific screening for research purposes will 
be necessary. 
 
CONSENT TIMING: The patient’s surrogate(s) will be approached by research study staff 
for discussion of the present research protocol only AFTER they have discussed all aspects 
of clinical care with the PCAS physician, had the opportunity to meet with a social worker, 
and only if they have voiced willingness to the PCAS physician to discuss participation in 
the present research protocol. This will occur PRIOR to placement of the intracranial access 
bolt (clinical care), since the monitoring probes are placed at the same time as the 
intracranial access bolt is placed (i.e. these steps are components of the same larger 
procedure). 
 
RESEARCH PROCEDURES: Patients who are candidates for multimodal neurological 
monitoring, whose surrogates have provided procedural consent as part of routine clinical 
care, and additionally agree to participation in the present proposal would undergo 
placement of the same intracranial access bolt, which would be fitted with routine clinical 
monitors, with the addition of the intracortical EEG probe (research). Intracranial access 
bolts will be placed by the neurosurgery team in the ICU under sterile conditions as per 
their usual protocol.  NOTE: At study initiation, cerebral blood flow monitoring was 
deemed to be a research intervention and thus addressed in the initial protocol; on 
subsequent IRB review we were asked to change this to part of the routine bundle of 
CLINICAL monitoring.  No subjects were enrolled subsequent to this change. 
 
For this study, a transcortical multi-contact EEG electrode (Spencer Depth Electrode, AD-
Tech, Racine, WI; FDA Regulation Number 882.1330) would be introduced via an 
otherwise-unused lumen. When fully inserted, the probe extend several millimeters below 
the surface of the brain parenychma. This monitoring system is used locally in other 
neurologically critically ill patient populations, such as for routine for neurophysiologic 
monitoring during epilepsy surgery. Our neurophysiology/EEG attending group and 
technologists are familiar with its use. The nondisposible components of the monitoring 

system are already owned by the institution and available for use in this project. 
 
Procedures will be performed in the usual sterile fashion at the bedside of patients in a 
neuroscience intensive care unit (4G, 4F or 5F) by Neurosurgery on call. Insertion of this 
device requires ~5-10 minutes to perform. Patients will require no additional analgesia or 
sedation beyond what is already provided as standard of care during post-cardiac arrest 
resuscitation.  
 
USE AND INTERPRETATION OF DATA FROM RESEARCH DEVICE: The information 
obtained from the research monitor will be displayed at the subject’s bedside and available 
for interpretation and use by the clinical providers (physicians, nurses, housestaff) at all 
times. Intracortical EEG data will be monitored in parallel with surface EEG recordings by 
the neurophysiology attending responsible for interpreting continuous EEGs (rotating call 
schedule). Generally, the attending reading continuous EEG is in communication with the 
Post-Cardiac Arrest Service and ICU physicians at least daily to communicate their 
interpretations, but communication occurs more frequently if there are seizures or other 
malignant EEG patterns that require intervention.  
 
No access to monitoring data will be withheld or delayed, and neither investigators nor 
clinicians blinded. At times, the investigators will also act as the subject’s clinical provider. 
Clinical decisions driven by the experimental monitors will be made solely by the ICU team 
in charge of the patient’s care. These may include the use of antiepileptic or sedating 
medications to treat seizures. Since seizures are significant determinants of the evolution 
of secondary brain injury in hypoxic-ischemic encephalopathy, we feel that it would be 
unethical to subject these patients to the risks of monitoring without the potential to 
benefit from the intervention. The study investigators will be available to discuss the 
interpretation of the experimental monitoring data, but clinical management in response to 
these data will not be dictated by research protocols. 
 
DURATION OF STUDY PROCEDURES: The device will be left in place until such time as the 
intracranial access bolt is deemed unnecessary by the Critical Care Medicine service 
treating the patient, usually about 5 days after placement. At the time of removal, the bolt 
and all of its contents will be removed by the neurosurgical service. 
 
STATISTICAL ANALYSIS PLAN: Descriptive statistics will be use to summarize population 
characteristics and the frequency of outcomes of interest in this study.