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

NCT06003517 | Unknown

• 1 other identifier: K3120
• Study Type: observational
• Target: 3,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Perioperative Complication

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (2)

Patients with perioperative safety events

Patients with perioperative safety events, including post extubation tracheal intubation, intraoperative cardiac arrest, allergic reactions.

Procedure: Screening with PSI check list

Patients without perioperative safety events

Patients without perioperative safety events, including post extubation tracheal intubation, intraoperative cardiac arrest, allergic reactions.

Procedure: Screening with PSI check list

Interventions

Screening with PSI check list PROCEDURE

Screening PSI with institutional check list

Patients with perioperative safety events; Patients without perioperative safety events

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Perioperative patients with anesthesia electronic records that can analysis the patient safety incident.

You may qualify if:

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

You may not qualify if:

• data incomplete
• data missing

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (1)

Department of Anesthesiology, Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

RECRUITING

MeSH Terms

Interventions

Mass Screening

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis; Health Surveys; Surveys and Questionnaires; Data Collection; Epidemiologic Methods; Investigative Techniques; Diagnostic Services; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Public Health Practice

Central Study Contacts

Yuan Tian, MD

CONTACT

8618810261573; counsissis@sina.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 13, 2023
• First Posted: August 22, 2023
• Study Start: December 10, 2022
• Primary Completion: December 31, 2024
• Study Completion: September 30, 2025
• Last Updated: August 22, 2023

Record last verified: 2023-08

Locations

CN (1)