Postoperative Complications of Orthopedic Surgery in Patients From High-altitude Regions: a Cohort Study.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 400
- 主要终点
- Postoperative venous thromboembolism
研究概览
简要总结
This study will focus on orthopedic surgery patients from high-altitude regions, utilizing smart wearables and monitoring tools to gather perioperative data, including heart rate, oxygen saturation, sleep quality, stress levels, and other relevant metrics. Regular follow-ups will assess recovery and complications, in addition to collecting medical records, lab results, imaging data, and other pertinent records. The ultimate goal is to establish a comprehensive follow-up cohort of orthopedic surgery patients from high-altitude areas.
详细描述
Prolonged exposure to hypoxic and low-pressure environments leads to structural remodeling and functional abnormalities in the cardiovascular, respiratory, and hematological systems of high-altitude populations. This elevates the risk of postoperative complications, particularly in patients undergoing orthopedic surgery, significantly impacting their recovery and quality of life. This study will focus on orthopedic surgery patients from high-altitude regions. Using smart wearable devices and other monitoring tools, comprehensive perioperative dynamic data of participants, including heart rate, heart rate variability, oxygen saturation, respiratory rate, sleep quality, activity levels, stress index, and other relevant indicators will be collected. Regular follow-ups will be conducted to evaluate postoperative recovery and monitor the incidence of perioperative complications. Additionally, perioperative data such as electronic medical records, laboratory test results, ECG waveforms, echocardiography, chest CT images, and other pertinent records will be also collected. Through that, this study aims to establish a follow-up cohort of orthopedic surgery patients from high-altitude regions.
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
- •Age ≥ 18 years;
- •ASA classification I-III;
- •Patients who have lived at an altitude above 2500 meters for more than 6 months ;
- •Patients scheduled for elective orthopedic surgery.
排除标准
- •Urgent or emergent surgery;
- •Expected hospital stay < 48 hours;
- •Inability to provide informed consent；
- •Patients who have been out of high-altitude regions for over three months.
结局指标
主要结局
Postoperative venous thromboembolism
时间窗: During hospitalization
Defined according to the European Perioperative Clinical Outcome (EPCO) criteria, including both deep vein thrombosis and pulmonary embolism.
次要结局
- Postoperative venous thromboembolism(Up to 2 weeks postoperatively)
- A composite of postoperative pulmonary complications(During hospitalization)
- Postoperative major adverse cardiovascular events(During hospitalization)
- Postoperative nausea and vomiting(During hospitalization)
- The quality of postoperative recovery(During hospitalization)
- Chronic pain after surgery(Up to 1 year postoperatively)
- Postoperative quality of life assessment(Up to 1 year postoperatively)
研究者
Chunling Jiang
Professor
West China Hospital