Cardiopulmonary Bypass Clinical Trial
— FLOWMAPCAOfficial title:
Impact of Cardiopulmonary Bypass Flow on Cerebral Autoregulation in Cardiac Surgery, a Cross-over Study
Verified date | September 2023 |
Source | Clinique de la Sauvegarde |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Cerebral autoregulation is defined by the capacity of the brain to maintain a constant cerebral blood flow (CBF) despite variations of arterial pressure. However, when the arterial pressure is below a critical threshold, cerebral blood decreases. This critical threshold is called the lower limit of cerebral autoregulation (LLA). Cardiopulmonary bypass is a unique environment wherein systemic blood flow is totally controlled by the cardiopulmonary bypass pump. High pump flows combined with low arterial pressures has been shown to not compromise neurologic postoperative outcomes. Our hypothesis is that that LLA may depend on the cardiopulmonary bypass flow, ie the LLA may decrease when the cardiopulmonary bypass flow increases, explaining why low arterial pressure may be well tolerated.
Status | Completed |
Enrollment | 40 |
Est. completion date | September 12, 2023 |
Est. primary completion date | July 3, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 90 Years |
Eligibility | Inclusion Criteria: - Patient, male or female, over the age of 18 - Patient scheduled to undergo valvular heart surgery with planned CPB - Patient with a Euroscore below 7% - Patient affiliated or entitled to a social security scheme - Patient having received informed information about the study and having signed a free and informed consent to participate in the study Exclusion Criteria: - Patient with untreated or uncontrolled severe hypertension despite treatment - Patient with chronic renal failure, with glomerular filtration < 30 mL/min/1.73m² or requiring a kidney transplant - Patient with left ventricular ejection fraction < 40% - Patient with a history of ischemic stroke - Patient having or about to benefit from renal vascular surgery - Patient with preoperative sepsis - Patient who required a norepinephrine infusion within 24 hours before surgery - Patient presenting with an inaccessible temporal Doppler window - Patient candidate for emergency surgery - Pregnant, parturient or breastfeeding woman - Patient with preoperative uni or bilateral carotid stenosis > 50% - Protected patient: adult under guardianship, curators or other legal protection, deprived of liberty by judicial or administrative decision |
Country | Name | City | State |
---|---|---|---|
France | Clinique de la Sauvegarde | Lyon |
Lead Sponsor | Collaborator |
---|---|
Clinique de la Sauvegarde | GCS Ramsay Santé pour l'Enseignement et la Recherche |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | measurement of MAP LLA (mmHg) | Determination of MAP LLA according to the calculation of the mean velocity index | 15 to 25 min during the procedure |
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