Monitoring brain oxygen levels during heart surgery
A Multicenter, Randomized, Controlled Clinical Trial of Cerebral Oxygen Saturation Monitoring In Cardiac Surgery (COSMICS)
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 326 (estimated) |
| Ages | 60 Years and up |
| Sex | All |
| 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 |
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.
Who should consider this trial
Good fit: Ideal candidates are patients aged 60 or older scheduled for elective coronary artery bypass graft surgery with a satisfactory preoperative cognitive assessment.
Not a fit: Patients with pre-existing cognitive dysfunction or significant neurological issues may not benefit from this study.
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 performed: 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.
Eligibility criteria
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 this trial is running
Rio de Janeiro, RJ and 1 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.