Ignite Creation Date:
2025-12-25 @ 3:45 AM
Ignite Modification Date:
2025-12-26 @ 2:32 AM
Study NCT ID:
NCT06660602
Status:
RECRUITING
Last Update Posted:
2025-03-19
First Post:
2024-10-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Perioperative Cerebral Function Assessment for Cardiac Surgery
Sponsor:
China National Center for Cardiovascular Diseases
Organization:
Study Overview
Official Title:
Perioperative Cerebral Function Assessment for Cardiac Surgery
Status:
RECRUITING
Status Verified Date:
2025-03
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:
PEACE
Brief Summary:
Perioperative neurological complications in cardiovascular surgical procedures are associated with a significant risk of mortality and disability. This study is aimed at identifying the specific risk factors associated with these neurological complications during the perioperation and developing a comprehensive predictive model designed to enhance clinical decision-making and improve patient safety. The research is divided into three key phases: preoperative, intraoperative, and postoperative, each involving targeted evaluations and continuous monitoring to provide a thorough assessment of patient risk and outcomes.
Detailed Description:
Before operation, a thorough assessment is conducted, encompassing a detailed analysis of participants' medical histories, demographic profiles, cerebrovascular structure, and cerebral function. These variables are systematically examined to identify risk factors for neurological complications.
Intraoperatively, real-time monitoring of cerebral blood flow and regional oxygen saturation is conducted using advanced techniques, including transcranial Doppler ultrasound and near-infrared spectroscopy, to evaluate the impact of surgical procedures on cerebral perfusion and oxygenation.
Postoperative monitoring emphasizes the identification of potential complications, such as cognitive dysfunction, seizures, delirium, and stroke. By integrating data from all stages during perioperation, the investigators want to develop a predictive model for perioperative brain function assessment. This model is intended to provide clinicians with a reliable tool for more precise risk assessment and timely intervention, thereby reducing the incidence of neurological complications and improving the prognosis for patients.
Intraoperatively, real-time monitoring of cerebral blood flow and regional oxygen saturation is conducted using advanced techniques, including transcranial Doppler ultrasound and near-infrared spectroscopy, to evaluate the impact of surgical procedures on cerebral perfusion and oxygenation.
Postoperative monitoring emphasizes the identification of potential complications, such as cognitive dysfunction, seizures, delirium, and stroke. By integrating data from all stages during perioperation, the investigators want to develop a predictive model for perioperative brain function assessment. This model is intended to provide clinicians with a reliable tool for more precise risk assessment and timely intervention, thereby reducing the incidence of neurological complications and improving the prognosis for patients.
Study Oversight
Has Oversight DMC:
True
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?:
False
Is an FDA AA801 Violation?: