Ignite Creation Date:
2024-05-06 @ 8:07 PM
Last Modification Date:
2024-10-26 @ 3:20 PM
Study NCT ID:
NCT06250374
Status:
RECRUITING
Last Update Posted:
2024-02-26
First Post:
2024-01-12
Brief Title:
Assessment of the Cerebral Perfusion During the Period of Deep Hypothermia at 18C in Patient Undergoing Pulmonary Endarterectomy Surgery
Sponsor:
Fondation Hôpital Saint-Joseph
Organization:
Fondation Hôpital Saint-Joseph
Study Overview
Official Title:
Assessment of the Cerebral Perfusion During the Period of Deep Hypothermia at 18C in Patient Undergoing Pulmonary Endarterectomy Surgery
Status:
RECRUITING
Status Verified Date:
2023-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HYPO-TEP
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 04 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 arrests body temperature is lowered at 18-20C 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 18-20C 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
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 arrests body temperature is lowered at 18-20C 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 18-20C 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None