Outcomes of Vascular Surgery in COVID-19 Infection: National Cohort Study (Covid-VAS)
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- 30-days mortality
Study Overview
Brief Summary
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.
Detailed Description
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Exclusion Criteria
- •Not informed consent signed.
Outcomes
Primary Outcomes
30-days mortality
Time Frame: 30-days
30-days mortality after vascular surgery in patients with COVID-19 infection
Secondary Outcomes
- 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)