Predictive Value of Early Postoperative Heart Rate Variability Changes From Baseline for Postoperative Delirium in Older Adults Undergoing Major Abdominal Surgery: A Prospective Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Occurrence of postoperative delirium within 7 days after surgery
研究概览
简要总结
This prospective observational cohort study aims to investigate whether early postoperative changes in heart rate variability (HRV) relative to baseline are associated with the development of postoperative delirium (POD) in older patients undergoing elective major abdominal surgery under general anesthesia. Patients aged 65-85 years will be enrolled. Resting HRV will be measured at 10:00 AM on the day of surgery before anesthesia induction and at the same time point on the first postoperative day using a validated heart rate monitoring device. HRV parameters will be derived from standardized 5-minute recordings. Changes in HRV parameters from baseline will be calculated, and their associations with POD occurrence will be evaluated. Postoperative delirium will be assessed daily from 24 hours after surgery to postoperative day 7, using the 3-Minute Diagnostic Interview for Confusion Assessment Method (3D-CAM). The study will also explore the potential utility of HRV-derived markers for early POD risk stratification. Approximately 500 participants will be enrolled.
详细描述
Postoperative delirium (POD) is a common neurocognitive complication following major surgery in older adults and is associated with increased morbidity, prolonged hospitalization, and adverse clinical outcomes. However, objective and easily obtainable biomarkers for early identification of patients at high risk of POD remain limited.
Heart rate variability (HRV) reflects autonomic nervous system regulation and may provide a non-invasive marker of physiological stress and impaired autonomic adaptability. Major abdominal surgery induces substantial systemic stress responses, including inflammation, neuroendocrine activation, and autonomic disturbances. Whether early postoperative alterations in HRV are associated with subsequent POD development remains unclear.
This is a single-center, prospective observational cohort study. Patients aged 65-85 years undergoing elective major abdominal surgery under general anesthesia will be consecutively enrolled. Baseline demographic characteristics, comorbidities, frailty status, cognitive function, and perioperative clinical variables will be collected.
Resting HRV will be measured at 10:00 AM on the day of surgery before anesthesia induction and again at the same time point on the first postoperative day using a validated heart rate monitoring device. HRV analysis will be performed based on standardized 5-minute recordings in accordance with established recommendations for short-term HRV assessment. Time-domain, frequency-domain, and nonlinear HRV parameters will be calculated.
Postoperative delirium will be assessed daily from 24 hours after surgery to postoperative day 7 using the 3-Minute Diagnostic Interview for Confusion Assessment Method (3D-CAM). Additional clinical outcomes include delirium severity, delirium duration, postoperative cognitive function, quality of recovery, postoperative nausea and vomiting, and length of hospital stay.
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 85 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients admitted to Jiangsu Provincial People's Hospital who are scheduled to undergo elective major abdominal surgery under general anesthesia.
- •Older patients aged 65 to 85 years.
- •Expected postoperative hospital stay of ≥7 days.
- •Body mass index (BMI) between 18.5 and 28.0 kg/m².
- •American Society of Anesthesiologists (ASA) physical status classification I-III.
- •Patients who are conscious, mentally competent, and able to cooperate with heart rate variability (HRV) measurements, questionnaire assessments, and follow-up evaluations.
- •Patients who voluntarily participate in the study and provide written informed consent.
排除标准
- •Patients with ASA physical status classification ≥IV or patients with end-stage cancer.
- •Patients with implanted cardiac pacemakers, implantable cardioverter-defibrillators, or other electronic devices that may interfere with ECG signal acquisition.
- •Patients with severe or unstable cardiovascular diseases, including but not limited to acute coronary syndrome, symptomatic bradycardia, sick sinus syndrome, second-degree or higher atrioventricular block, atrial fibrillation, atrial flutter, frequent premature beats, or other arrhythmias that may affect heart rate variability analysis.
- •Patients with diseases affecting autonomic nervous system function, including confirmed primary or secondary autonomic dysfunction, such as Parkinson's disease, multiple system atrophy, severe diabetic autonomic neuropathy, severe peripheral neuropathy, poorly controlled hyperthyroidism or hypothyroidism, and systemic amyloidosis.
- •Patients with a history of organic central nervous system diseases or psychiatric disorders, including major traumatic brain injury, stroke (ischemic or hemorrhagic), intracranial mass lesions, epilepsy, schizophrenia, bipolar disorder, major depressive disorder, or other severe psychiatric disorders.
- •Patients with severe baseline cognitive impairment or inability to complete cognitive assessments, including any of the following: (1) preoperative baseline Montreal Cognitive Assessment (MoCA) score <14 points; (2) previously diagnosed dementia, preoperative delirium, coma, or other severe disturbances of consciousness; or (3) inability to complete standardized cognitive assessments due to severe visual impairment, hearing impairment, language barriers, or other causes.
- •Patients unable to undergo HRV measurement within 24 hours after surgery, including those with severe perioperative complications, emergency reoperation, extremely unstable vital signs, or requiring continuous deep sedation after surgery.
- •Patients who have taken anticholinergic medications, beta-blockers, antiarrhythmic drugs, or other medications that may significantly affect autonomic function within 1 month before study enrollment.
- •Patients who are currently participating in any other clinical trial.
研究组 & 干预措施
Elderly Patients Undergoing Elective Major Abdominal Surgery
Elderly patients undergoing elective major abdominal surgery under general anesthesia will be prospectively enrolled and followed for postoperative delirium.
干预措施: Perioperative Heart Rate Variability Changes (Other)
结局指标
主要结局
Occurrence of postoperative delirium within 7 days after surgery
时间窗: Postoperative day 1 to postoperative day 7 after surgery
Postoperative delirium will be assessed daily from postoperative day 1 to postoperative day 7 using the Chinese version of the 3-Minute Diagnostic Interview for CAM-defined Delirium (3D-CAM). Delirium diagnosis will be based on the Confusion Assessment Method (CAM) algorithm.
次要结局
- Severity of postoperative delirium(Postoperative day 1 to postoperative day 7 after surgery)
- Duration of postoperative delirium(Postoperative day 1 to postoperative day 7 after surgery)
- Change in cognitive function after surgery(Postoperative day 7)
- Quality of recovery after surgery(Postoperative day 7)
研究者
Wu Junbei
Associate Chief Physician
The First Affiliated Hospital with Nanjing Medical University