Monitoring Neurological Deterioration in Anaesthetised Patients With Electroencephalogram (EEG)

NCT02691338 | Unknown

• 1 other identifier: 0459-15-Rambam-CTIL
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

CVA

Outcome Measures

Primary Outcomes (1)

• EEG-based interhemispheric synchronization index

  Interhemispheric synchronization is measured retrospectively - for the whole period the patient is under general anesthesia

Study Arms (2)

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).

Other: EEG; Other: Routine follow up tests

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.

Other: EEG

Interventions

EEG OTHER

EEG analysis

Control - healthy individuals; patients undergoing thrombectomy

Routine follow up tests OTHER

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

patients undergoing thrombectomy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with CVA undergoing percutaneous thrombectomy under general anesthesia

You may qualify if:

• 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

You may not qualify if:

• Age \< 18 years
• no informed consent

Sponsors & Collaborators

• Rambam Health Care Campus: lead

Study Sites (1)

Rambam Health Care Campus

Haifa, Israel

RECRUITING

Related Publications (7)

• 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.

  PMID: 26536542 BACKGROUND

• 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.

  PMID: 25520374 BACKGROUND

• 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.

  PMID: 17893451 BACKGROUND

• 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.

  PMID: 23370205 BACKGROUND

• 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.

  PMID: 22429809 BACKGROUND

• 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.

  PMID: 23805094 BACKGROUND

• 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.

  PMID: 25445244 BACKGROUND

Study Officials

• Dana Baron Shahaf, MD PhD

  Rambam Health Care Center

  STUDY DIRECTOR

Central Study Contacts

Dana Baron Shahaf, MD PhD

CONTACT

972-50-2065929; dana_bs@rambam.health.gov.il

Goded Shahaf, MD PhD

CONTACT

972-50-2062334; godeds@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2016
• First Posted: February 25, 2016
• Study Start: February 1, 2016
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2025
• Last Updated: December 8, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)