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NCT06003517 Clinical Trial

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

Perioperative Complication Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06003517
Other study ID # K3120
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date December 10, 2022
Est. completion date September 30, 2025

Study information
Verified date August 2023
Source Peking Union Medical College Hospital
Contact Yuan Tian, MD
Phone 8618810261573
Email counsissis@sina.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 3000
Est. completion date September 30, 2025
Est. primary completion date December 31, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - perioperative patients with anesthesia electronic records. - aged more than 18 years old. Exclusion Criteria: - data incomplete - data missing

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Screening with PSI check list
Screening PSI with institutional check list

Locations
Country Name City State
China Department of Anesthesiology, Peking Union Medical College Hospital Beijing Beijing

Sponsors (1)
Lead Sponsor Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary Occurrence of PSI Occurrence of patient safety incident, including post extubation tracheal intubation, intraoperative cardiac arrest, allergic reactions. Perioperative period, from the beginning of the surgery to 7 days after the surgery.
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