Clinical Trials Logo

Clinical 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%. 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.


Clinical Trial 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


Related Conditions & MeSH terms


NCT number NCT02691338
Study type Observational
Source Rambam Health Care Campus
Contact Dana Baron Shahaf, MD PhD
Phone 972-50-2065929
Email dana_bs@rambam.health.gov.il
Status Recruiting
Phase
Start date February 2016
Completion date December 2025

See also
  Status Clinical Trial Phase
Terminated NCT04113525 - Transcutaneous Spinal and Peripheral Stimulation and Wrist Robotic Therapy for Patients With Spastic Stroke N/A
Completed NCT00574782 - Evaluation of the Efficacy of Rosuvastatin in Daily Practice in Untreated High Risk Patients (CHALLENGE) N/A
Completed NCT02207023 - Healthy Lifestyles After Stroke - Stroke Coach N/A
Completed NCT03668990 - Feasability, Validty and Reliability of Inertial Sensors N/A
Not yet recruiting NCT03742674 - Independence Stairs Climbing Ability Prediction During the Sub-acute Rehabilitation Phase of People After Stroke
Completed NCT02332915 - Treatment Intensity - Apraxia of Speech N/A
Completed NCT05196737 - DDN in Stroke--COBRE N/A
Completed NCT04095377 - Development of Automated Analysis to Electroencephelogram (EEG) Data in Patients Treated at the Sagol Hyperbaric Medicine and Research Center at the Years 2017-2019.
Completed NCT00792428 - Non-invasive Brain Stimulation and Occupational Therapy To Enhance Stroke Recovery N/A
Not yet recruiting NCT03377062 - CVA in Patients Suffering From Decreased Consciousness, Confusion or Headaches to an Emergency Room
Enrolling by invitation NCT04309305 - Robotic Exoskeleton Assisted Gait Post Stroke Phase 1
Completed NCT02693834 - Effects of Two Different Types of Ankle Foot Orthoses on Gait Outcomes in Patients With Subacute Stroke. N/A
Completed NCT05720013 - Acute Effects of Beetroot Juice on Locomotor Economy and Capacity in Chronic Stroke N/A
Not yet recruiting NCT04684212 - Can the Lambre Device Occlude IRRegular And Large Appendages in Patients With Non-Valvular AF N/A
Active, not recruiting NCT04535232 - Feasibility of Enhancing Recovery of Sensory Deficits After Stroke With rTMS N/A