Clinical trial NCT06250374: Assessment of the Cerebral Perfusion During the Period of Deep Hypothermia at 18°C in Patient Undergoing Pulmonary Endarterectomy Surgery.
Official title: Assessment of the Cerebral Perfusion During the Period of Deep Hypothermia at 18°C in Patient Undergoing Pulmonary Endarterectomy Surgery.
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Hypothermia
Cerebral Perfusion
Transcranial Doppler Ultrasound
Pulmonary Hypertension
Keywords: Pulmonary endarterectomy
cerebral perfusion
Hypothermia
Transcranial doppler ultrasound
Cardiopulmonary bypass
Lead sponsor: Fondation Hôpital Saint-Joseph
Sponsor class: OTHER
First posted: 2024-02-09
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief 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 criteria: 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 outcomes:
measure: Assessment of cerebral blood perfusion during deep hypothermia
timeFrame: M1: Baseline-normothermia after induction of general anesthesia (H0) M2: During CPB-at 18°C-before cardiac arrest (H2) M3: After cardiac arrest-at 18°C before (H4) M4: End of surgery-normothermia (H6)
Secondary outcomes:
measure: Correlation between NIRS and middle cerebral arteries velocity values for each measure.
timeFrame: M1: Baseline-normothermia after induction of general anesthesia (H0) M2: During CPB-at 18°C-before cardiac arrest (H2) M3: After cardiac arrest-at 18°C before (H4) M4: End of surgery-normothermia (H6)
measure: Seek for post-circulatory arrest hyperemia
timeFrame: M2: During CPB after cooling at 18°C before cardiac arrest (H2). M3: After cardiac arrest at 18°C before rewarming period (H4).
Other outcomes:
Locations:
city: Le Plessis-Robinson
country: France
facility: Hôpital Marie Lannelongue
Study officials:
References:
citation: Liu Y, Chen K, Mei W. Neurological complications after cardiac surgery: anesthetic considerations based on outcome evidence. Curr Opin Anaesthesiol. 2019 Oct;32(5):563-567. doi: 10.1097/ACO.0000000000000755.
citation: Brown CH 4th, Neufeld KJ, Tian J, Probert J, LaFlam A, Max L, Hori D, Nomura Y, Mandal K, Brady K, Hogue CW; Cerebral Autoregulation Study Group; Shah A, Zehr K, Cameron D, Conte J, Bienvenu OJ, Gottesman R, Yamaguchi A, Kraut M. Effect of Targeting Mean Arterial Pressure During Cardiopulmonary Bypass by Monitoring Cerebral Autoregulation on Postsurgical Delirium Among Older Patients: A Nested Randomized Clinical Trial. JAMA Surg. 2019 Sep 1;154(9):819-826. doi: 10.1001/jamasurg.2019.1163.