CVANCT02691338
Monitoring Neurological Deterioration in Anaesthetised Patients With Electroencephalogram (EEG)
An observational study of CVA, run by Rambam Health Care Campus at 1 site in Israel.
Trial 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%. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- CVA
- What is being tested?
- EEG and Routine follow up tests
- How many people
- 150 participants
- Where
- 1 siteIsrael
- Study dates
- Feb 2016to Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with CVA undergoing percutaneous thrombectomy under general anesthesia
Who may be able to join
- 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
Who cannot join
- Age < 18 years
- no informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Monitoring Neurological Deterioration in Anaesthetised Patients With Electroencephalogram (EEG): Demonstration With Patients Undergoing Neurovascular Intervention After Cerebrovascular Attack (CVA).
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.
Read the 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.
- Conditions
- CVA
- Being tested
- EEG, Routine follow up tests
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EEGOther
EEG analysis
Routine follow up testsOther
Routine tests for patients after CVA. This include: neurologic evaluation, Brain CT, Angiography
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. Receives: Other: EEG |
What is being measured
The primary outcome is the main question the study is designed to answer.
EEG-based interhemispheric synchronization index
Measured: Interhemispheric synchronization is measured retrospectively - for the whole period the patient is under general anesthesia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2016 (estimated)
- Study startFeb 2016
- Primary completionDec 2024 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for CVAStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rambam Health Care Campus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dana Baron Shahaf, MD PhD, Study director, Rambam Health Care Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02691338
- Sponsor's protocol ID
- 0459-15-Rambam-CTIL
- Status last verified
- Dec 2023
- First submitted
- 9 Feb 2016
- Last updated
- 8 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 26536542Mozaffarian 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.
PubMed 25520374Moritz 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.
PubMed 17893451Jauch 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.
PubMed 23370205Foreman 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.
PubMed 22429809Shahaf 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.
PubMed 23805094Shahaf 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.
PubMed 25445244
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monitoring Neurological Deterioration in Anaesthetised Patients With Electroencephalogram (EEG): Demonstration With Patients Undergoing Neurovascular Intervention After Cerebrovascular Attack (CVA).
- ClinicalTrials.gov ID
- NCT02691338
- Acronym / sponsor ID
- 0459-15-Rambam-CTIL
- Conditions
- CVA
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Rambam Health Care CampusUniversity, hospital or other
- Study start
- Feb 2016
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 25 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients undergoing thrombectomy | – | Other: EEG, Other: Routine follow up tests150 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). |
| Control - healthy individuals | – | Other: EEG20 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with CVA undergoing percutaneous thrombectomy under general anesthesia
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Age < 18 years
- no informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EEGEEG analysis | Other | Control - healthy individuals, patients undergoing thrombectomy |
| Routine follow up testsRoutine tests for patients after CVA. This include: neurologic evaluation, Brain CT, Angiography | Other | patients undergoing thrombectomy |
Primary outcome
EEG-based interhemispheric synchronization index
Time frame: Interhemispheric synchronization is measured retrospectively - for the whole period the patient is under general anesthesia
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2023.
- Background: PubMed 26536542Shahaf 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.
- Background: PubMed 25520374Mozaffarian 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.
- Background: PubMed 17893451Moritz 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.
- Background: PubMed 23370205Jauch 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.
- Background: PubMed 22429809Foreman 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.
- Background: PubMed 23805094Shahaf 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.
- Background: PubMed 25445244Shahaf 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dana Baron Shahaf, MD PhD study director
Rambam Health Care Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of CVA, run by Rambam Health Care Campus at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dana Baron Shahaf, MD PhD (972-50-2065929, dana_bs@rambam.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
EEG-based interhemispheric synchronization index (time frame: Interhemispheric synchronization is measured retrospectively - for the whole period the patient is under general anesthesia). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02691338, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2023.