Validation of Neurokeeper's Algorithm on Patients Undergoing Cardiac Surgery.
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Stroke
- Sponsor
- Neurokeeper Technologies
- Locations
- 1
- Primary Endpoint
- Neurological detrioration detection
- Last Updated
- 13 years ago
Overview
Brief Summary
The primary objective of the study is to check the ability of Neurokeeper's algorithm system to detect and monitor changes in cerebral electrophysiological parameters as compared to clinical evaluation in patients undergoing cardiac surgery.
The secondary objectives is correlations of EEG + ERP measurements with clinical evaluations as assessed by NIHSS ThiS study is a prospective, open label, single arm, self control, single center study.
This study will be conducted in 50 subjects according to the inclusions/exclusions criteria.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Age \> 18 years old.
- •Patients undergoing cardiac surgery .
Exclusion Criteria
- •Previous major hemispheric stroke.
- •Any known major hemispheric lesion.
- •Significant movement disorder.
- •Local skull or skin affliction which prevents electrodes application.
- •Any known condition which in the opinion of the investigator may interfere with the protocol implementation.
Outcomes
Primary Outcomes
Neurological detrioration detection
The primary objective of the study is to validate an EEG base algorithm system to detect and monitor changes in cerebral electrophysiological parameters as compared to clinical evaluation in patients undergoing cardiac surgery.
Secondary Outcomes
- Time from deterioration to detection