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

NCT ID: NCT06250374

Last Updated: 2025-03-13

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-24
• Study Completion Date: 2025-05-24

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.

Conditions

Hypothermia; Cerebral Perfusion; Transcranial Doppler Ultrasound; Pulmonary Hypertension

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Patients with thromboendarterectomy surgery

Anesthesia was induced with sufentanil 0.3 g/kg, etomidate 0.3-0.4 mg/kg, rocuronium 0.4 mg/kg and maintained with continuous infusion Propofol and sufentanil. A pulmonary arterial catheter was inserted in all patients. Patients were cooled by means of the oxygenator heat exchanger at a rate of one degree Celsius every three minutes. Rewarming was achieved at a rate of one degree Celsius every five to ten minutes.

The following measures were performed:

Measure 1: In normo-thermia after induction of general anesthesia Measure 2: On CPB, before circulatory arrest and in hypothermia at 18-20°C Measure 3: On bypass, after circulatory arrest and in hypothermia at 18-20°C Measure 4: At the end of the procedure, after weaning from the bypass and in normothermia.

For each measure mean arterial pressure, cardiac output, PaCO2, pH, bilateral NIRS value were also recorded.

Group Type: EXPERIMENTAL

Bilateral trans-cranial Doppler ultrasound

Intervention Type: PROCEDURE

Velocity measurements in the middle cerebral artery are made using an ultrasound probe applied to the patient's temple during surgery.

Interventions

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.

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fondation Hôpital Saint-Joseph

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hôpital Marie Lannelongue

Le Plessis-Robinson, , France

Countries

France

References

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.

Reference Type: BACKGROUND

PMID: 31145196 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 31116358 (View on PubMed)

Other Identifiers

2023-A00270-45

Identifier Type: -

Identifier Source: org_study_id