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

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

Status
Active, not recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06250374
Acronym
HYPO-TEP
Enrollment
45
Registered
2024-02-09
Start date
2023-08-24
Completion date
2025-05-24
Last updated
2025-03-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cerebral Perfusion, Hypothermia, Pulmonary Hypertension, Transcranial Doppler Ultrasound

Keywords

Pulmonary endarterectomy, cerebral perfusion, Hypothermia, Transcranial doppler ultrasound, Cardiopulmonary bypass

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.

Interventions

PROCEDUREBilateral 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.

Sponsors

Fondation Hôpital Saint-Joseph
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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.

Design outcomes

Primary

MeasureTime frameDescription
Assessment of cerebral blood perfusion during deep hypothermiaM1: 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)Cerebral blood perfusion during deep hypothermia (18-20°C) will be assessed by measuring mean blood flow velocities in the middle cerebral arteries (MCAs) using trans-cranial Doppler ultrasound (DTC) at different time of the surgery (Four measures in total). All measure are performed during the time of the surgery. The first measure (M1) is baseline to which the other measure will be compared to.

Secondary

MeasureTime frameDescription
Correlation between NIRS and middle cerebral arteries velocity values for each measure.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)For each measure of middle cerebral arteries blood flow velocity performed during the surgery, the value of the near infrared spectroscopy (NIRS) is recorded. A total of four measures is performed during the time of the surgery.
Seek for post-circulatory arrest hyperemiaM2: During CPB after cooling at 18°C before cardiac arrest (H2). M3: After cardiac arrest at 18°C before rewarming period (H4).Comparison of the middle cerebral arteries blood flow velocities during the period of hypothermia, before and after cardiac arrest.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026