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Monitoring Neurological Deterioration in Anaesthetised Patients With Electroencephalogram (EEG)

Monitoring Neurological Deterioration in Anaesthetised Patients With Electroencephalogram (EEG): Demonstration With Patients Undergoing Neurovascular Intervention After Cerebrovascular Attack (CVA).

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02691338
Enrollment
150
Registered
2016-02-25
Start date
2016-02-29
Completion date
2025-12-31
Last updated
2023-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

CVA

Brief summary

The incidence of perioperative stroke in the non-cardiac, non-vascular, non-neurological high risk surgical population is 2%. It is higher (\ 5%) for cardiac surgery and carotid endarterectomy patients, with a stroke associated mortality of up to 60%. These patients could be immediately treated if their condition was detected on time. Currently, there is no standard brain monitoring procedure for anaesthetised patients. The purpose of the proposed study is to optimize and validate an online monitor for neurological deterioration under anaesthesia based on an easily operatable EEG system comprised of 4 electrodes, a reference electrode and a newely developed algorithm for analyzing the EEG signal. The monitor aims at generating an immediate warning at the onset of neurological deterioration. For the purpose of technology development with a minimal sample size, it is necessary to select a patient population that demonstrates significant neurological dynamics under anaesthesia. We will therefore focus on anesthesized patients undergoing neurovascular thrombectomy after CVA.

Detailed description

The research aim is to validate a novel ground-breaking and easy-to-use EEG-based algorithm for sensing cerebrovascular accident (CVA) events under anaesthesia. Today there is no standard tool for CVA detection in anaesthetized patients. Thus the possibility of waking up from anaesthesia with severe brain damage is devastating. Patients undergoing cardiac surgery (such as valve replacement, CABG, thoracic aorta replacement, PTCA, TAVI (trans-aortic valve implantation)), carotid endarterectomy and surgery in sitting position, are at exceptionally high risk. We have developed a unique algorithm for detecting brain ischemia in anaesthetized patients, based on data acquired from 4 EEG electrodes. Our final goal is to develop a system that triggers an alarm when an ischemia occurs in an anaesthetized patient and during the peri-operative period. In order to validate and optimize our system, we require a small sample size to test and validate the technology. The population for this study includes patients with acute CVA who undergo mechanical thrombectomy under anaesthesia. Although these patients already have CVA, clinical dynamics is high in this population, and will enable a demonstration of our ability to recognize immediate changes in neurological status (improvement or deterioration). We believe this innovative EEG based system could be of major significance to millions of patients annually.

Interventions

OTHEREEG

EEG analysis

OTHERRoutine follow up tests

Routine tests for patients after CVA. This include: neurologic evaluation, Brain CT, Angiography

Sponsors

Rambam Health Care Campus
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Informed consent (by individual or guardian) * Undergoing thrombectomy procedure under anaesthesia for acute CVA * for control: * Healthy individual, with no neurological disease undergoing sedation for procedure

Exclusion criteria

* Age \< 18 years * no informed consent

Design outcomes

Primary

MeasureTime frame
EEG-based interhemispheric synchronization indexInterhemispheric synchronization is measured retrospectively - for the whole period the patient is under general anesthesia

Countries

Israel

Contacts

Primary ContactDana Baron Shahaf, MD PhD
dana_bs@rambam.health.gov.il972-50-2065929
Backup ContactGoded Shahaf, MD PhD
godeds@gmail.com972-50-2062334

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026