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

NCT ID: NCT06003517

Last Updated: 2023-08-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

3000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-12-10

Study Completion Date

2025-09-30

Brief Summary

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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

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Conditions

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Perioperative Complication

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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Patients with perioperative safety events

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

Screening with PSI check list

Intervention Type PROCEDURE

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.

Screening with PSI check list

Intervention Type PROCEDURE

Screening PSI with institutional check list

Interventions

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Screening with PSI check list

Screening PSI with institutional check list

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* data incomplete
* data missing
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Peking Union Medical College Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Department of Anesthesiology, Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Yuan Tian, MD

Role: CONTACT

8618810261573

Facility Contacts

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Yuan Tian, MD

Role: primary

+86 18810261573

Other Identifiers

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K3120

Identifier Type: -

Identifier Source: org_study_id

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