Retrospective Study on Perioperative Safety and Quality Control Based on Real World Data

Recruiting

• Conditions: Perioperative Complication
• Interventions: Procedure: Screening with PSI check list

• Registration Number: NCT06003517
• Lead Sponsor: Peking Union Medical College Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-12-10
• Status Verified: 2023-08
• Study First Submitted: 2023-08-13
• Study First Submitted QC: 2023-08-21
• Last Update Submitted: 2023-08-21
• Study First Posted: 2023-08-22
• Last Update Posted: 2023-08-22
• Primary Completion: 2024-12-31
• Study Completion: 2025-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 3000

Inclusion Criteria

• perioperative patients with anesthesia electronic records.
• aged more than 18 years old.

Exclusion Criteria

• data incomplete
• data missing

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with perioperative safety events	Screening with PSI check list	Patients with perioperative safety events, including post extubation tracheal intubation, intraoperative cardiac arrest, allergic reactions.
Patients without perioperative safety events	Screening with PSI check list	Patients without perioperative safety events, including post extubation tracheal intubation, intraoperative cardiac arrest, allergic reactions.

Primary Outcome Measures

Name	Time	Method
Occurrence of PSI	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.

Trial Locations

Locations (1)

Department of Anesthesiology, Peking Union Medical College Hospital; 🇨🇳 Beijing, Beijing, China