Outcomes of Vascular Surgery in COVID-19 Infection: National Cohort Study (Covid-VAS)
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- 30-days mortality
研究概览
简要总结
There is an urgent need to understand the outcomes of COVID-19 infected patients who undergo surgery, specially vascular surgery. Capturing real-world data and sharing Spanish national experience will inform the management of this complex group of patients who undergo surgery throughout the COVID-19 pandemic, improving their clinical care.
The global community has recognised that rapid dissemination and completion of studies in COVID-19 infected patients is a high priority, so we encourage all stakeholders (local investigators, ethics committees, IRBs) to work as quickly as possible to approve this project.
This investigator-led, non-commercial, non-interventional study is extremely low risk, or even zero risk. This study does not collect any patient identifiable information (including no dates) and data will not be analysed at hospital-level.
详细描述
To determine 30-day mortality in patients with COVID-19 infection who undergo vascular surgery.
This will inform future risk stratification, decision making, and patient consent.
Inclusion criteria
The inclusion criteria are:
• Adults (age ≥18 years) undergoing ANY type of vascular surgery in an operating theatre, this includes open surgery, endovascular surgery or hybrid procedures.
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
- •Adults (age ≥18 years) undergoing ANY type of vascular surgery in an operating theatre, this includes obstetrics. AND
- •Either before or after surgery: (i) lab test confirmed COVID-19 infection or (ii) clinical diagnosis of COVID-19 infection (no test performed).
- •Therefore this study should capture:
- •emergency surgery patients with clinical diagnosis or lab confirmation of COVID-19 infection before surgery.
- •emergency surgery patients with clinical diagnosis or lab confirmation of COVID-19 infection after surgery.
- •elective surgery patients with clinical diagnosis or lab confirmation of COVID-19 infection after surgery.
排除标准
- •Not informed consent signed.
结局指标
主要结局
30-days mortality
时间窗: 30-days
30-days mortality after vascular surgery in patients with COVID-19 infection
次要结局
- Postoperative ICU admission(30-days)
- 30-days reoperation(30-days)
- Postoperative respiratory failure(30-days)
- 7-days mortality(7-days)
- Postoperative acute respiratory distress syndrome (ARDS)(30-days)
- Postoperative sepsis(30-days)