Evaluation of Intraoperative Cerebral Desaturation and Risk Factors Associated With Cognitive Dysfunction After Cardiac Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 102
- 试验地点
- 1
- 主要终点
- Incidence of Postoperative Cognitive Dysfunction (POCD)
研究概览
简要总结
This study examines whether decreases in brain oxygen levels during cardiac surgery are linked to postoperative cognitive dysfunction and identifies other factors that may increase the risk of cognitive impairment.
详细描述
In this prospective study, the relationship between intraoperative cerebral oxygen saturation and postoperative cognitive dysfunction (POCD) was investigated in adult patients undergoing elective cardiac surgery with cardiopulmonary bypass (CPB). Patients with a preoperative Mini-Mental State Examination (MMSE) score ≥ 24, no history of cerebrovascular disease, and no conditions that could interfere with near-infrared spectroscopy (NIRS) monitoring were included.
Measurements were recorded at the following time points: T0 (before induction), T1 (15 minutes after induction), T2 (5 minutes after initiation of CPB), T3 (during the hypothermic phase of CPB), T4 (rewarming phase of CPB, at 34 °C), T5 (termination of CPB), and T6 (upon admission to the intensive care unit). Patients were divided into two groups according to postoperative cognitive outcomes: those who developed POCD and those who did not.
Cognitive function was assessed using the MMSE preoperatively and on postoperative days 4, 7, and 30. During surgery, cerebral oxygen saturation was measured at predefined time points using NIRS probes placed on the frontal region, and detailed intraoperative and perioperative data were recorded. Standardized interventions were implemented when a decrease of more than 20% in regional cerebral oxygen saturation (rSO₂) from baseline was detected in order to maintain adequate cerebral oxygenation.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Planned elective CPB surgery
- •Provision of written informed consent
- •Absence of communication barriers that could interfere with preoperative and postoperative MMSE assessment
- •No history of cerebrovascular disease
- •Preoperative MMSE score ≥24
- •Education level of at least high school
- •Absence of any frontal deformity that could hinder NIRS monitoring
排除标准
- •Preoperative use of antipsychotic or antidepressant medications
- •Emergency cardiac surgery indication
- •Presence of ≥50% carotid artery stenosis
研究组 & 干预措施
Group POCD: Patients develop cognitive dysfunction after cardiac surgery
The POCD group (n=24) comprised patients undergoing elective cardiac surgery with cardiopulmonary bypass who developed postoperative cognitive dysfunction, defined as an MMSE score ≤23 at any postoperative assessment. ( Postoperative day 4 ,7, 30)
Group non-POCD : Patients did not develop postoperative cognitive dysfunction
The non-POCD group (n = 50) consisted of adult patients undergoing elective cardiac surgery with cardiopulmonary bypass whose MMSE scores remained ≥24 at all postoperative assessments, indicating no postoperative cognitive dysfunction.
结局指标
主要结局
Incidence of Postoperative Cognitive Dysfunction (POCD)
时间窗: Baseline (preoperative, before surgery) and postoperative day 4, postoperative day 7, and postoperative day 30.
Postoperative cognitive dysfunction (POCD) is defined as a decline in cognitive performance assessed using the Mini-Mental State Examination (MMSE), with a score of ≤23 at any postoperative assessment compared with a preoperative baseline MMSE score of ≥24. This primary outcome evaluates the association between intraoperative cerebral oxygen desaturation, measured by near-infrared spectroscopy (NIRS) as a reduction of \>20% from baseline regional cerebral oxygen saturation (rSO₂), and postoperative cognitive dysfunction following cardiac surgery with cardiopulmonary bypass.
次要结局
- Intraoperative Cerebral Oxygen Desaturation Measured by NIRS(Perioperatively (during surgery) through immediate postoperative period (upon ICU admission).)
- Postoperative Cognitive Performance Over Time Assessed by MMSE(Baseline (preoperative, before surgery) and postoperative day 4, postoperative day 7, and postoperative day 30.)
- Operation Time(From skin incision to skin closure during surgery)
- Cardiopulmonary Bypass (CPB) Duration(From initiation to termination of cardiopulmonary bypass during surgery (single intraoperative assessment).)
- Aortic Cross-Clamp (ACC) Duration(From application to removal of the aortic cross-clamp during surgery (single intraoperative assessment))
- Time to Extubation(From completion of surgery until successful extubation, assessed up to 30 postoperative days)
- Intensive Care Unit Length of Stay(From ICU admission after surgery until ICU discharge, assessed up to 30 postoperative days.)
- Hospital Length of Stay(From hospital admission for cardiac surgery until hospital discharge, assessed up to 30 postoperative days.)
- Correlation Between Perioperative Clinical Variables and Postoperative MMSE Scores(Postoperative day 4, postoperative day 7, and postoperative day 30.)
研究者
ŞULE BALK
Anesthesiology and Reanimation doctor
Bursa Yuksek Ihtisas Training and Research Hospital