Registry of Cardio/Neurovascular Anesthesia Including the Database of Biological Signals During Anesthesia, Preoperative Assessment and Prognosis in Patients

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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04833751

Enrollment

10000

Registered

2021-04-06

Start date

2018-12-14

Completion date

2028-12-31

Last updated

2024-07-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac Anaesthesia

Keywords

Cardiac Diseases, Biosignal data, Cardiac Surgical Procedures, Cardiovascular Surgical Procedures, Heart Valve Prosthesis Implantation

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: 1. Preoperative patient assessment 2. All monitored perioperative biosignal data 3. Intraoperative and immediate postoperative hemodynamic information, input/output balance, and medication usage 4. 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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

19 Years to No maximum

Healthy volunteers

Inclusion criteria

1. Adults age 19 and older 2. Patients scheduled for anesthesia at a cardiovascular hospital for cardiovascular surgery or procedures

Exclusion criteria

1\) 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

Design outcomes

Primary

Measure	Time frame	Description
all cause mortality	one year after surgery	All-cause mortality within one year after surgery

Secondary

Measure	Time frame	Description
Acute kidney injury	within 7days after surgery	The definition of AKI refers to the Kidney Disease: Improving Global Outcomes (KDIGO) Acute Kidney Injury Work Group's KDIGO Clinical Practice Guideline for Acute Kidney Injury.
surgical re-exploration	within 30 days (±3 days) after surgery	require a return to the operating room for bleeding with or without tamponade, graft occlusion, valve dysfunction, or other cardiac reason
deep sternal wound infection	within 30 days (±3 days) after surgery	infection involving muscle, bone, or mediastinum requiring operative intervention
Postprocedural myocardial infarction	within 2days after surgery	Defined by an increase in CK-MB or cardiac troponin (cTn) levels.
stroke/cerebrovascular accident	within 30 days (±3 days) after surgery	Confirmed neurological deficit caused by a blood supply disturbance to the brain lasting more than 24 hours
Readmission rate	within 30days of the date of discharge from the index cardiac surgery hospitalization	readmission to an acute care hospital within 30 days of discharge from the cardiac surgery hospitalization
prolonged mechanical ventilation	within 30 days (±3 days) after surgery	intubation required for more than 24 hours

Countries

South Korea

Contacts

Primary ContactSarah Soh, MD, PhD

yeonchoo@yuhs.ac82-2-2228-8512

Outcome results