Retrospective Study on Perioperative Safety and Quality Control Based on Real World Data
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 3,000
- Locations
- 1
- Primary Endpoint
- Occurrence of PSI
Study Overview
Brief Summary
Based on the data from the anesthesia record electronic system, patient safety incident (PSI) electronic reporting system and related PSI retrospective cohort in the past 10 years, this project intends to carry out structured and consistent (real world data)RWD processing, and conduct (real world evidence)RWE research related to perioperative safety and quality control in order to characterize the epidemiology of perioperative PSIs, explore the related factors, and construct a prediction model, and on the basis of which to construct a standardized platform for reporting and analysis of perioperative PSIs based on RWD. On this basis, a standardized platform for PSI reporting and analysis was constructed based on RWD.
Study Design
- Study Type
- Observational
- Observational Model
- Case Control
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •perioperative patients with anesthesia electronic records.
- •aged more than 18 years old.
Exclusion Criteria
- •data incomplete
- •data missing
Outcomes
Primary Outcomes
Occurrence of PSI
Time Frame: Perioperative period, from the beginning of the surgery to 7 days after the surgery.
Occurrence of patient safety incident, including post extubation tracheal intubation, intraoperative cardiac arrest, allergic reactions.
Secondary Outcomes
No secondary outcomes reported