Registry of Cardiovascular Anesthesia Including the Database of Biological Signals During Anesthesia, Preoperative Assessment and Prognosis in Patients: Severance Cardiovascular Surgery Prospective (SECURE) Database

Yonsei University1 site in 1 country10,000 target enrollmentDecember 14, 2018

ConditionsCardiac Anaesthesia

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Cardiac Anaesthesia
Sponsor: Yonsei University
Enrollment: 10000
Locations: 1
Primary Endpoint: all cause mortality
Status: Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to establish a registry database for patients undergoing anesthesia for cardiovascular surgery or procedures in our operating or hybrid room. The following information will be collected:

Preoperative patient assessment
All monitored perioperative biosignal data
Intraoperative and immediate postoperative hemodynamic information, input/output balance, and medication usage
Short- and long-term prognosis from electronic medical records This database will be used to develop a vigilant monitoring system that integrates multiple biosignal data simultaneously, contributing to the improvement of anesthesia care.

Registry

clinicaltrials.gov

Start Date

December 14, 2018

End Date

December 31, 2028

Last Updated

last year

Study Type

Observational

Sex

All

Investigators

Sponsor

Yonsei University

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Adults age 19 and older
•Patients scheduled for anesthesia at a cardiovascular hospital for cardiovascular surgery or procedures

Exclusion Criteria

•Emergency (surgery/procedure room transfer within 1 hour of visit) where there is insufficient time for the subject (adult 19 years of age or older) or his/her representative (adult incapable of consent) to decide whether to participate in the study

Outcomes

Primary Outcomes

all cause mortality

Time Frame: one year after surgery

All-cause mortality within one year after surgery

Secondary Outcomes

deep sternal wound infection(within 30 days (±3 days) after surgery)
surgical re-exploration(within 30 days (±3 days) after surgery)
prolonged mechanical ventilation(within 30 days (±3 days) after surgery)
stroke/cerebrovascular accident(within 30 days (±3 days) after surgery)
Postprocedural myocardial infarction(within 2days after surgery)
Acute kidney injury(within 7days after surgery)
Readmission rate(within 30days of the date of discharge from the index cardiac surgery hospitalization)