Intraoperative PCO₂ Gap and Lactate Levels as Early Predictors of Postoperative Cognitive Dysfunction in Elderly Patients Undergoing Cardiac Surgery With Cardiopulmonary Bypass
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 185
- 主要终点
- Predictive Value of Intraoperative PCO₂ Gap and Arterial Lactate Levels for Postoperative Cognitive Dysfunction (POCD
研究概览
简要总结
This prospective observational study aims to evaluate whether intraoperative venous-to-arterial carbon dioxide partial pressure difference (PCO₂ gap) and arterial lactate levels can serve as early predictors of postoperative cognitive dysfunction (POCD) in elderly patients undergoing elective cardiac surgery with cardiopulmonary bypass. Intraoperative measurements of PCO₂ gap and lactate will be correlated with perioperative cognitive outcomes assessed using the Montreal Cognitive Assessment (MoCA) and postoperative delirium screening using the Confusion Assessment Method for the ICU (CAM-ICU).
详细描述
This prospective observational cohort study will be conducted at El-Demerdash Hospital, Ain Shams University. Patients aged 65 years and older undergoing elective cardiac surgery with cardiopulmonary bypass will be enrolled. Serial measurements of the PCO₂ gap and arterial lactate will be obtained before induction, during CPB, at the end of CPB, 30 minutes after weaning from CPB, and immediately postoperatively. Cognitive function will be evaluated preoperatively and one month after surgery using the Montreal Cognitive Assessment (MoCA). Postoperative delirium will be assessed daily during ICU stay using CAM-ICU. The study will investigate the predictive value of intraoperative PCO₂ gap and lactate levels for postoperative cognitive dysfunction and determine potential cutoff values associated with cognitive decline.
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
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥65 years.
- •Undergoing elective cardiac surgery with cardiopulmonary bypass (e.g., coronary artery bypass grafting or valve surgery).
- •American Society of Anesthesiologists (ASA) Physical Status III.
- •Able to provide written informed consent.
排除标准
- •Refusal or inability to provide written informed consent.
- •Pre-existing neurological disorders (e.g., Alzheimer's disease, Parkinson's disease, or stroke with residual neurological deficits).
- •Severe psychiatric disorders requiring active treatment.
- •History of drug or alcohol abuse.
- •Emergency cardiac surgery.
- •Significant visual or hearing impairment interfering with cognitive testing.
- •Inability to complete preoperative cognitive assessment.
- •Preoperative dementia (MoCA score <20).
- •Significant pulmonary disease (e.g., COPD or lung cancer).
- •Patients meeting the protocol-defined intraoperative or postoperative exclusion criteria.
研究组 & 干预措施
Elderly Patients Undergoing Elective Cardiac Surgery with Cardiopulmonary Bypass
Patients aged 65 years or older undergoing elective cardiac surgery with cardiopulmonary bypass. Participants will undergo serial intraoperative measurements of the venous-to-arterial carbon dioxide partial pressure difference (PCO₂ gap) and arterial lactate levels. Postoperative cognitive function will be assessed using the Montreal Cognitive Assessment (MoCA), and postoperative delirium will be screened using the Confusion Assessment Method for the ICU (CAM-ICU).
结局指标
主要结局
Predictive Value of Intraoperative PCO₂ Gap and Arterial Lactate Levels for Postoperative Cognitive Dysfunction (POCD
时间窗: Baseline (preoperative) and 1 month postoperatively
To evaluate whether intraoperative venous-to-arterial carbon dioxide partial pressure difference (PCO₂ gap) and arterial lactate levels predict postoperative cognitive dysfunction in elderly patients undergoing elective cardiac surgery with cardiopulmonary bypass. POCD will be assessed by changes in Montreal Cognitive Assessment (MoCA) scores from the preoperative baseline to 1 month postoperatively.
次要结局
- Early Postoperative Delirium Assessed by the Confusion Assessment Method for the ICU (CAM-ICU)(Daily during the first 5 postoperative days or until ICU discharge, whichever occurs first)
- Determination of Cutoff Values for Intraoperative PCO₂ Gap and Arterial Lactate Levels Predictive of POCD(1 month postoperative)
- Correlation of (CAM - ICU) to MoCA for prediction of cognitive impairmentat 5 days post operative(CAM-ICU: Daily during the first 5 postoperative days; MoCA: baseline preoperatively and 1 month postoperatively)
- Incidence of POCD at 1 month postoperatively, defined by a decline in MoCA scores from baseline in elderly cardiac patient.(Baseline (preoperative) and 1 month postoperatively)
- Duration of Mechanical Ventilation in Relation to Intraoperative PCO₂ Gap and Arterial Lactate Levels(Measured from the end of surgery until successful extubation (up to 30 days))
- Duration of Intensive Care Unit Stay in Relation to Intraoperative PCO₂ Gap and Arterial Lactate Levels(From ICU admission after surgery until ICU discharge, up to 30 days)
- Duration of Hospital Stay in Relation to Intraoperative PCO₂ Gap and Arterial Lactate Levels(From the end of surgery until hospital discharge, up to 30 days)