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

• Sponsor: Peking Union Medical College Hospital (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT06003517
• Collaborator: (none)
• Enrollment: 3,000
• Location: 1
• Anticipated Duration (Months): 33.7
• Patients Per Site Per Month: 89.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Perioperative Complication	Procedure: Screening with PSI check list

Study Design

• Study Type: Observational
• Anticipated Enrollment: 3000 participants
• Observational Model: Case-Control
• Time Perspective: Retrospective
• Official Title: Retrospective Study on Perioperative Safety and Quality Control Based on Real World Data
• Actual Study Start Date: Dec 10, 2022
• Anticipated Primary Completion Date: Dec 31, 2024
• Anticipated Study Completion Date: Sep 30, 2025

Arms and Interventions

Arm	Intervention/Treatment
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; Screening PSI with institutional 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; Screening PSI with institutional check list

Outcome Measures

Primary Outcome Measures

1. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Anesthesiology, Peking Union Medical College Hospital	Beijing	Beijing	China	100730

Sponsors and Collaborators

• Peking Union Medical College Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Peking Union Medical College Hospital
• ClinicalTrials.gov Identifier: NCT06003517
• Other Study ID Numbers: K3120
• First Posted: Aug 22, 2023
• Last Update Posted: Aug 22, 2023
• Last Verified: Aug 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Aug 22, 2023