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Monitoring Neurological Deterioration in Anaesthetised Patients With Electroencephalogram (EEG)

NCT ID: NCT02691338

Last Updated: 2023-12-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-02-29

Study Completion Date

2025-12-31

Brief Summary

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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

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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.

Conditions

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CVA

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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patients undergoing thrombectomy

150 anesthetized patients undergoing intra-arterial catheterization for thrombectomy after CVA. The patients will be recruited at the Rambam Health Center, Haifa, Israel. The patients will undergo EEG recording during the procedure, without changing patient's standard treatment care. The EEG recording will continue after the procedure for four hours approximately, while the patients are admitted to intensive care unit (ICU).

EEG

Intervention Type OTHER

EEG analysis

Routine follow up tests

Intervention Type OTHER

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

Control - healthy individuals

20 health individuals under general anesthesia or sedation for other surgery or procedures. They will undergo EEG recording during the surgery/ procedure, to validate the sensitivity of the EEG to the effect of the anaesthetic medications.

EEG

Intervention Type OTHER

EEG analysis

Interventions

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EEG

EEG analysis

Intervention Type OTHER

Routine follow up tests

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rambam Health Care Campus

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Dana Baron Shahaf, MD PhD

Role: STUDY_DIRECTOR

Rambam Health Care Center

Locations

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Rambam Health Care Campus

Haifa, , Israel

Site Status RECRUITING

Countries

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Israel

Central Contacts

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Dana Baron Shahaf, MD PhD

Role: CONTACT

Phone: 972-50-2065929

Email: [email protected]

Goded Shahaf, MD PhD

Role: CONTACT

Phone: 972-50-2062334

Email: [email protected]

References

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Shahaf DB, Shahaf G, Mehta J, Venkatraghavan L. Intracarotid Etomidate Decreases the Interhemispheric Synchronization in Electroencephalogram (EEG) During the Wada Test. J Neurosurg Anesthesiol. 2016 Oct;28(4):341-6. doi: 10.1097/ANA.0000000000000241.

Reference Type BACKGROUND
PMID: 26536542 (View on PubMed)

Mozaffarian D, Benjamin EJ, Go AS, Arnett DK, Blaha MJ, Cushman M, de Ferranti S, Despres JP, Fullerton HJ, Howard VJ, Huffman MD, Judd SE, Kissela BM, Lackland DT, Lichtman JH, Lisabeth LD, Liu S, Mackey RH, Matchar DB, McGuire DK, Mohler ER 3rd, Moy CS, Muntner P, Mussolino ME, Nasir K, Neumar RW, Nichol G, Palaniappan L, Pandey DK, Reeves MJ, Rodriguez CJ, Sorlie PD, Stein J, Towfighi A, Turan TN, Virani SS, Willey JZ, Woo D, Yeh RW, Turner MB; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart disease and stroke statistics--2015 update: a report from the American Heart Association. Circulation. 2015 Jan 27;131(4):e29-322. doi: 10.1161/CIR.0000000000000152. Epub 2014 Dec 17. No abstract available.

Reference Type BACKGROUND
PMID: 25520374 (View on PubMed)

Moritz S, Kasprzak P, Arlt M, Taeger K, Metz C. Accuracy of cerebral monitoring in detecting cerebral ischemia during carotid endarterectomy: a comparison of transcranial Doppler sonography, near-infrared spectroscopy, stump pressure, and somatosensory evoked potentials. Anesthesiology. 2007 Oct;107(4):563-9. doi: 10.1097/01.anes.0000281894.69422.ff.

Reference Type BACKGROUND
PMID: 17893451 (View on PubMed)

Jauch EC, Saver JL, Adams HP Jr, Bruno A, Connors JJ, Demaerschalk BM, Khatri P, McMullan PW Jr, Qureshi AI, Rosenfield K, Scott PA, Summers DR, Wang DZ, Wintermark M, Yonas H; American Heart Association Stroke Council; Council on Cardiovascular Nursing; Council on Peripheral Vascular Disease; Council on Clinical Cardiology. Guidelines for the early management of patients with acute ischemic stroke: a guideline for healthcare professionals from the American Heart Association/American Stroke Association. Stroke. 2013 Mar;44(3):870-947. doi: 10.1161/STR.0b013e318284056a. Epub 2013 Jan 31.

Reference Type BACKGROUND
PMID: 23370205 (View on PubMed)

Foreman B, Claassen J. Quantitative EEG for the detection of brain ischemia. Crit Care. 2012 Dec 12;16(2):216. doi: 10.1186/cc11230. No abstract available.

Reference Type BACKGROUND
PMID: 22429809 (View on PubMed)

Shahaf G, Pratt H. Thorough specification of the neurophysiologic processes underlying behavior and of their manifestation in EEG - demonstration with the go/no-go task. Front Hum Neurosci. 2013 Jun 24;7:305. doi: 10.3389/fnhum.2013.00305. eCollection 2013.

Reference Type BACKGROUND
PMID: 23805094 (View on PubMed)

Shahaf G, Fisher T, Aharon-Peretz J, Pratt H. Comprehensive analysis suggests simple processes underlying EEG/ERP - demonstration with the go/no-go paradigm in ADHD. J Neurosci Methods. 2015 Jan 15;239:183-93. doi: 10.1016/j.jneumeth.2014.10.016. Epub 2014 Nov 1.

Reference Type BACKGROUND
PMID: 25445244 (View on PubMed)

Other Identifiers

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0459-15-Rambam-CTIL

Identifier Type: -

Identifier Source: org_study_id