Personalized cardiac anaesthesia and its effects on neurological outcomes in heart surgery patients
Impact of Personalised Cardiac Anaesthesia and Cerebral Autoregulation on Neurological Outcomes in Patients Undergoing Cardiac Surgery (PRECISION)
This study is testing if personalized blood pressure management during heart surgery can help prevent neurological problems in patients.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 500 (estimated) |
| Ages | 65 Years and up |
| Sex | All |
| Sponsor | University Hospital, Basel, Switzerland Academic / other |
| Locations | 4 sites (Basel and 3 other locations) |
| Trial ID | NCT05595954 on ClinicalTrials.gov |
What this trial studies
This international, multicentre prospective cohort study aims to evaluate the relationship between the duration and magnitude of mean arterial pressure (MAP) outside of individual cerebral autoregulation limits and adverse neurological events in patients undergoing cardiac surgery. Utilizing non-invasive techniques such as near-infrared spectroscopy (NIRS) and transcranial Doppler (TCD), the study will monitor blood pressure tailored to individual characteristics to potentially reduce complications. Additionally, it will explore biological associations between neurological outcomes, neurobiomarkers, and genetic factors to enhance understanding and improve patient safety and quality of life.
Who should consider this trial
Good fit: Ideal candidates for this study are patients scheduled for elective primary or reoperative coronary artery bypass graft and/or valvular and/or ascending aorta surgery requiring cardiopulmonary bypass.
Not a fit: Patients undergoing urgent or emergency surgeries, or those requiring heart and/or lung transplantation, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved neurological outcomes and reduced incidence of postoperative complications for cardiac surgery patients.
How similar studies have performed: While this approach is innovative, similar studies have shown promise in understanding the impact of cerebral autoregulation on neurological outcomes, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Elective primary or reoperative coronary artery bypass graft and/or valvular and/or ascending aorta surgery requiring cardiopulmonary bypass. Exclusion Criteria: * Surgery requiring moderate (28-31.9ºC) or deep (\<28ºC) hypothermic circulatory arrest; * Heart and/or lung transplantation; * Urgent (within 24 hours) and emergency surgery; * Inability to follow procedures or insufficient knowledge in English, German or French; * Inability to give consent. Participants who undergo cardiac surgery under minimal extracorporeal circulation will also be excluded.
Where this trial is running
Basel and 3 other locations
- Clinic for Anaesthesia, Intermediate Care, Prehospital Emergency Medicine and Pain Therapy, University Hospital Basel — Basel, Switzerland (Recruiting)
- Inselspital, Bern University Hospital — Bern, Switzerland (Recruiting)
- Cambridge University Hospitals and Brain Physics Lab — Cambridge, United Kingdom (Active_not_recruiting)
- Royal Papworth Hospital, Department of Anaesthesia and Intensive Care — Cambridge, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Nuno V. Gomes, MD — Clinic for Anaesthesia, Intermediate Care, Prehospital Emergency Medicine and Pain Therapy, University Hospital Basel
- Study coordinator: Nuno V. Gomes, MD
- Email: nuno.gomes@usb.ch
- Phone: +41 61 328 64 46
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.