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Clinical Trials in France / NCT06250374
Active, not recruiting Not applicable

Assessment of the Cerebral Perfusion During the Period of Deep Hypothermia at 18°C in Patient Undergoing Pulmonary Endarterectomy Surgery.

NCT06250374 · tracked via the Priya Life Science France tracker
Phase
Not applicable
Started
2023-08-24
Last updated
2025-03-13

Condition(s) studied

HypothermiaCerebral PerfusionTranscranial Doppler UltrasoundPulmonary Hypertension

Investigational drug(s) / intervention(s)

Bilateral trans-cranial Doppler ultrasound

Bilateral trans-cranial Doppler ultrasound: Velocity measurements in the middle cerebral artery are made using an ultrasound probe applied to the patient's temple during surgery.

Study summary

Cardiopulmonary bypass (CPB) surgery present risk of acute postoperative neurological complications. These complications are most often postoperative cognitive dysfunction (confusion, cognitive disorders, executive disorders) with a prevalence of up to 40% at 5 years, and ischemic (stroke) with an incidence of between 0.4 and 14%. The causes are usually multifactorial, but altered cerebral perfusion during CPB surgery is an important prognostic factor. Data regarding the effect of deep hypothermia on cerebral perfusion during CPB in adult are scarce. Currently, aortic arch replacement following aortic dissection or aneurysm, and pulmonary artery endarterectomy (PAE) in the treatment of pulmonary hypertension of post embolic origin are performed under deep hypothermia.

In this latter indication, the need to obtain a completely bloodless operating field necessitates complete circulatory arrest during short period of time to enable the surgeon to optimally remove the clot materials located into the pulmonary arteries.

To protect the brain and avoid irreversible brain injury during circulatory arrest(s), body temperature is lowered at 18-20°C. Deep hypothermia can lead to significant arterial vasoconstriction, which can reduce the blood supply to the brai. It also increases the solubility of CO2 in the blood, leading to respiratory alkalosis, which can also lead to vasoconstriction of cerebral vessels, increasing the risk of ischemic lesions.

In adult there is no consistent data on the cerebral perfusion during PAE surgery under deep hypothermia at 18-20°C. Animal studies showed that cerebral regulation seems to be preserved under these conditions. A better understanding of the effect of deep hypothermia on cerebral perfusion during PAE surgery is essential to adapt our management to limit the occurrence of postoperative neurological complications.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Scheduled for pulmonary artery thromboendarterectomy surgery. * Patient with free, written and informed consent. * Patient affiliated to a social security scheme (beneficiary or beneficiary's beneficiary). * French-speaking patient. Exclusion Criteria: * Patient refusing to participate in the study. * Patient under guardianship. * Patient deprived of liberty. * Pregnant or breast-feeding women.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Hôpital Marie Lannelongue Le Plessis-Robinson France

More Fondation Hôpital Saint-Joseph trials in France

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06250374 on ClinicalTrials.gov ↗ ← All trials in France