Status:
RECRUITING
Cerebral Oxygen Saturation Monitoring In Cardiac Surgery (COSMICS)
Lead Sponsor:
Instituto Nacional de Cardiologia de Laranjeiras
Conditions:
Cardiac Disease
Cognitive Dysfunction
Eligibility:
All Genders
60+ years
Phase:
NA
Brief Summary
Neurological dysfunction continues to be one of the complications of considerable concern in patients undergoing cardiac surgery. It was previously reported in the literature, that cerebral oxygen des...
Detailed Description
Despite all the progress over the last decades regarding the improvement of the perioperative care of patients with heart disease and the development of new surgical techniques, neurological dysfuncti...
Eligibility Criteria
Inclusion
- Age 60 or older
- Elective coronary artery bypass graft surgery using cardiopulmonary bypass
- Preoperative cognitive assessment by means of Mini-Mental State Examination (MMSE) test, greater than or equal to 24
- Signed informed consent
Exclusion
- Patients with focal neurologic deficit
- Carotid artery stenosis greater than 70%
- Patients with pre-existing cognitive dysfunction
- Patients with psychotic disorders
- History of allergy to adhesive part of the electrode
- History of craniofacial surgery
Key Trial Info
Start Date :
May 19 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 20 2024
Estimated Enrollment :
326 Patients enrolled
Trial Details
Trial ID
NCT04766554
Start Date
May 19 2021
End Date
July 20 2024
Last Update
May 28 2024
Active Locations (2)
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1
Instituto Nacional de Cardiologia
Rio de Janeiro, Rio de Janeiro, Brazil
2
Hospital São José
Criciúma, Santa Catarina, Brazil