Neurological Complications and Intensive-Care Workload After Emergency Repair of Acute Type A Aortic Dissection: A Retrospective Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 274
- 试验地点
- 1
- 主要终点
- Prolonged ICU length of stay (LOS ≥10 days)
研究概览
简要总结
Single-center retrospective cohort at China Medical University Hospital (Taichung, Taiwan) using fully de-identified electronic health records. Consecutive adults who underwent emergency repair of acute type A aortic dissection between 2021-01-01 and 2025-04-30 were pooled into one cohort. The study measures the incidence and patterns of early postoperative neurological complications and evaluates their association with intensive care unit (ICU) resource use, focusing on prolonged ICU length of stay (LOS ≥ 10 days), ICU and hospital LOS, and duration of mechanical ventilation (MV). No new data collection or patient contact occurs. Institutional Review Board (IRB) approval: CMUH114-REC1-139.
详细描述
Adults (≥ 18 years) undergoing emergency repair for acute type A aortic dissection (ATAAD) at China Medical University Hospital (CMUH) during 2021-01-01 to 2025-04-30 were screened. Exclusions: missing key variables, preoperative stroke within 30 days or modified Rankin Scale (mRS) ≥ 4, pregnancy. The analytic cohort included 274 of 309 screened patients. Neurological complications comprise radiology-confirmed stroke, other focal neurological deficits, paraplegia, or sustained coma/encephalopathy recorded by neurology consultation. Prolonged ICU stay is prespecified as ICU LOS ≥ 10 days in the index admission. Outcomes: primary outcomes are prolonged ICU stay and any postoperative neurological complication; secondary outcomes are ICU LOS (days), duration of mechanical ventilation (hours), hospital LOS (days), in-hospital mortality, and in-hospital death within 30 days of the index surgery. Analyses are performed in R version 4.5.1. Continuous variables are summarized as medians with interquartile ranges (IQRs) and compared using the Mann-Whitney U test; categorical variables are presented as counts and percentages and compared using chi-square or Fisher exact tests. Multivariable logistic regression identifies factors associated with prolonged ICU stay (ICU LOS ≥ 10 days) among hospital survivors using a priori covariates (age, sex, chronic kidney disease stage 4-5, operation time, cardiopulmonary bypass [CPB] time, intraoperative red blood cell [RBC] units transfused, postoperative acute kidney injury [AKI], any postoperative neurological complication). A prespecified sensitivity analysis in the full cohort treats the endpoint as ICU LOS ≥ 10 days or in-hospital death using the same prespecified covariates. Data were de-identified before analysis and stored on secure hospital servers; the study is minimal risk and does not involve United States Food and Drug Administration (US FDA) regulated products.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •Adults (≥18 years) who underwent emergency repair of acute type A aortic dissection at China Medical University Hospital between 2021-01-01 and 2025-04-30.
排除标准
- •Missing data in key variables required for analyses.
- •Preoperative ischemic stroke within 30 days before surgery or preoperative modified Rankin Scale ≥
- •Pregnancy.
结局指标
主要结局
Prolonged ICU length of stay (LOS ≥10 days)
时间窗: Through ICU discharge during the index admission (up to 30 days).
Proportion of participants with ICU LOS ≥10 days during the index ICU admission. Unit of measure: percent.
Any postoperative neurological complication
时间窗: Through hospital discharge during the index admission (up to 30 days).
Proportion with stroke (CT/MRI confirmed), other focal neurological deficits, paraplegia, or sustained coma/encephalopathy recorded by neurology consultation. Unit of measure: percent.
次要结局
- ICU length of stay (days)(Through ICU discharge during the index admission (up to 30 days).)
- Duration of mechanical ventilation (hours)(Through final extubation during the index hospitalization (up to 40 days).)
- Hospital length of stay (days)(Through hospital discharge during the index admission (up to 65 days).)
- In-hospital mortality(Through hospital discharge during the index admission (up to 30 days).)
- In-hospital mortality within 30 days(Up to 30 days after index surgery, during the index hospitalization.)