Recruitment

Recruitment Status
Not yet recruiting
Estimated Enrollment
Same as current

Summary

Conditions
Postoperative Delirium
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: single blindMasking: Single (Participant)Primary Purpose: Prevention

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

Description

Postoperative delirium (POD) is a common complication after cardiac surgery. Imbalance of cerebral oxygen supply and demand is one of the pathogenesis of postoperative delirium. The perioperative cerebral oxygen levels and postoperative delirium highly correlated, while as a high incidence of cerebr...

Postoperative delirium (POD) is a common complication after cardiac surgery. Imbalance of cerebral oxygen supply and demand is one of the pathogenesis of postoperative delirium. The perioperative cerebral oxygen levels and postoperative delirium highly correlated, while as a high incidence of cerebral oxygen desaturation(SCO2) in cardiac surgery, especially in extracorporeal circulation. Near infrared spectroscopy (NIRS) can monitor the SCO2 continuously, noninvasively, simultaneously on bilateral cerebral hemisphere, and monitoring will not restricted by extracorporeal circulation.Using NIRS to moniter and intervene thecerebral oxygen levels in extracorporeal circulation of heart surgery patients ,thereby reducing the incidence of postoperative delirium. This hypothesis has a very important clinical value. This study intends to include 140 patients, who requires extracorporeal circulation cardiac surgical treatment. All cases will be divided into trial group and control group preoperative follow-up.Two groups of patients in surgery will be both performed the investigator's existing standerd monitoring and surgery process. The trial group cases will be given NIRS monitoring in the whole surgical procedure. And once the SCO2 value below ideal levels (80% of the basic level or 50% of the absolute value), the intervention process will be started immediately to correct the low cerebral oxygen status, by adjusting the position of extracorporeal circulation arteriovenous catheter, stabilizing the mean arterial pressure, increasing oxygen supply and , adjusting the pump speed, etc. The control group cases will be only placed the probe of NIRS moniter. In 72 hours after the surgery , all patients will be assessed POD by cardiac surgery intensivecare unit(CICU) physicians according to delirium scale . This project intends to research monitoring brain oxygen supply and intervention can reduce the incidence of postoperative delirium.

Tracking Information

NCT #
NCT04212988
Collaborators
Not Provided
Investigators
Not Provided