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临床试验/NCT05782036
NCT05782036已完成不适用

Development, Validation and Clinical Application of a Recovery Scale After Cardiac Surgery: the Fuwai-CRS (Fuwai- Cardiac Recovery Scale)

China National Center for Cardiovascular Diseases1 个研究点 分布在 1 个国家目标入组 3,043 人开始时间: 2023年5月16日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
3,043
试验地点
1
主要终点
Death or unplanned readmission

研究概览

简要总结

Improving patient recovery after cardiac surgery is a critical priority. While improved surgical techniques have substantially reduced procedural mortality over the past decades, the inherent physiological insult of median sternotomy, cardiopulmonary bypass, and myocardial manipulation continues to impose significant challenges in patient's recovery experience, such as pain, sleep disorders. Paradoxically, this critical recovery phase remains underexplored, as traditional outcome metrics predominantly focus on mortality and major morbidity endpoints. However, no cardiac surgery-specific tools currently exist to adequately capture postoperative recovery experience, creating barriers to optimal care. Accordingly, the investigators aim to develop and validate a recovery scale after cardiac surgery and evaluate its clinical performance compared to the generic scale (QoR-15)

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

入选标准

  • Elective cardiac surgery

排除标准

  • Emergency surgery
  • Age ≤ 18 years
  • Refuse to participate in this study
  • prolonged postoperative mechanical ventilation exceeding 24 hours reoperation or perioperative death

结局指标

主要结局

Death or unplanned readmission

时间窗: 3-month post operative

次要结局

  • In-hospital mortality(From surgery to discharge, up to 7 days)
  • In-hospital stroke(From surgery to discharge, up to 7 days)
  • In-hospital myocardial infarction(From surgery to discharge, up to 7 days)
  • In-hospital acute renal failure(From surgery to discharge, up to 7 days)
  • In-hospital sternal wound infection(From surgery to discharge, up to 7 days)
  • In-hospital reoperation(From surgery to discharge, up to 7 days)
  • Length of hospital stay(Approximately 7 days)

研究者

发起方
China National Center for Cardiovascular Diseases
申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

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