NCT06250374Active, not recruiting
Assessment of the Cerebral Perfusion During the Period of Deep Hypothermia at 18°C in Patient Undergoing Pulmonary Endarterectomy Surgery.
Source: ClinicalTrials.gov · Last updated 13 Mar 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 45 (actual)
- First submitted
- 12 Jan 2024
- Start date
- 24 Aug 2023
- Primary completion date
- 24 Feb 2025
- Lead sponsor
- Fondation Hôpital Saint-Joseph
- NCT number
- NCT06250374
What you commit to
- Study type: Interventional
- Participants enrolled: 45
- From 24 Aug 2023 to the primary completion date, 24 Feb 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- Patient refusing to participate in the study.
- Patient under guardianship.
- Patient deprived of liberty.
- Pregnant or breast-feeding women.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hôpital Marie Lannelongue Coordinator of this site? Confirm its status | Le Plessis-Robinson | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.