Predicting Cerebrovascular Adverse Events Post Cardiac Surgery with Cardiopulmonary Bypass by Means of Cerebral AutoreguLation Indices
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Cardiac Disease
- Sponsor
- IRCCS Policlinico S. Donato
- Enrollment
- 104
- Locations
- 1
- Primary Endpoint
- Cerebral Oxymetry index (CoX)
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
The aims of this study are: i) to assess cerebral autoregulation and autonomic control within the different phases of cardiac surgery with cardiopulmonary bypass; ii) to compare cerebral autoregulation measures derived via cerebral blood flow velocity estimated by transcranial Doppler device with simpler measurements derived from near infrared spectroscopy; iii) to develop a predictive model of postoperative cerebrovascular outcome (overt or silent stroke) based on the extracted indices.
Investigators
Vlasta Bari
Principal Investigator
IRCCS Policlinico S. Donato
Eligibility Criteria
Inclusion Criteria
- •age older than 18 years
- •spontaneous sinus rhythm
- •no pregnancy
- •signed informed consent
Exclusion Criteria
- •age lower than 18 years
- •absence of sinus rhythm
- •autonomic disorders
- •concomitant carotid intervention
- •reintervention
- •contraindication to MRI
- •pregnancy
- •impossibility of informed consent
Outcomes
Primary Outcomes
Cerebral Oxymetry index (CoX)
Time Frame: 36 months
CoX is an index describing the state of cerebral autoregulation derived from NIRS and mean arterial pressure. It ranges between 0 and 1. CoX = 1 means perfect coupling. Cox=0 means uncoupling. It will be computed for all participants in BASAL, ANESTH, CPBasurements derived from near infrared spectroscopy
Autoregulation index (ARI)
Time Frame: 36 months
ARI is an index describing the state of cerebral autoregulation from mean cerebral blood velocity and mean arterial pressure. It ranges between 1 and 9. ARI\>4 means working autoregulation. ARI\<4 means impaired autoregulation. It will be computed for all participants in BASAL, ANESTH, CPB.
number of patients developing cerebrovascular adverse events
Time Frame: 36 months
The number of patients developing cerebrovascular adverse events will be assessed by the presence of positive lesions as detected by DW-MRI.
Secondary Outcomes
- Baroreflex sensitivity(36 months)