Monitoring brain oxygen levels during heart surgery
Official title: A Multicenter, Randomized, Controlled Clinical Trial of Cerebral Oxygen Saturation Monitoring In Cardiac Surgery (COSMICS)
Run by Instituto Nacional de Cardiologia de Laranjeiras · NCT04766554 · Data updated 2026-05-14
This study is no longer in our active list. It may have stopped recruiting or finished. The details below are as of 2026-05-14 and are kept for reference. Check ClinicalTrials.gov for its current status, or see similar studies below.
This study tests if keeping an eye on brain oxygen levels during heart surgery can help older patients avoid memory and thinking problems afterward.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 60 Years and up |
| Sex | All |
| Enrollment | 326 (estimated) |
| Sponsor | Instituto Nacional de Cardiologia de Laranjeiras Academic / other |
| Locations | 2 sites (Rio de Janeiro, RJ and 1 other locations) |
| Trial ID | NCT04766554 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are patients aged 60 or older scheduled for elective coronary artery bypass graft surgery with a satisfactory preoperative cognitive assessment.
✕Probably not a fit
Patients with pre-existing cognitive dysfunction or significant neurological issues may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study investigates the impact of continuous cerebral oximetry monitoring on neurocognitive outcomes in patients undergoing coronary artery bypass surgery. By utilizing a non-invasive technique called near-infrared spectroscopy (NIRS), the study aims to optimize cerebral oxygenation through a predetermined intervention protocol. The goal is to determine if maintaining adequate cerebral oxygen levels can reduce the incidence of cognitive impairment associated with cardiac surgery. The study includes patients aged 60 and older who are undergoing elective surgery and have a preoperative cognitive assessment score above a certain threshold.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the risk of cognitive dysfunction in patients undergoing cardiac surgery.
How similar studies have gone: Previous studies have suggested a potential benefit of cerebral oximetry monitoring, but this study aims to provide more definitive evidence through a well-designed protocol.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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
Where it's running
-
Instituto Nacional de Cardiologia
Rio de Janeiro, Rj, Brazil Recruiting -
Hospital São José
Criciúma, Sc, Brazil Recruiting
Study contacts
- Principal investigator: Carlos Galhardo, MD — Instituto Nacional de Cardiologia
- Study coordinator: Carlos Galhardo, MD
- Email: cgalhardo@uol.com.br
- Phone: +55(21)999115844
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.