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

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.

Study Overview

• Status: Recruiting
• Conditions: Cardiac Anaesthesia

• Study Type: Observational
• Enrollment (Estimated): 10000

Contacts and Locations

• Study Contact: Name: Sarah Soh, MD, PhD; Phone Number: 82-2-2228-8512; Email: yeonchoo@yuhs.ac

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Recruiting
    • Yonsei University Health System, Severance Hospital
    • Contact: Sarah Soh, MD. PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing cardio/neurovascular surgery or procedure

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Anesthesia for cardiovascular surgery or procedure; Patients undergoing anesthesia in an operating room or hybrid room for cardiovascular surgery or procedure.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Yonsei University
• Investigators: Principal Investigator: Sarah Soh, MD, PhD, Department of Anesthesiology and Pain Medicine, Yonsei Cardiovascular Hospital, Yonsei University College of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): December 14, 2018
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: April 1, 2021
• First Submitted That Met QC Criteria: April 5, 2021
• First Posted (Actual): April 6, 2021

Study Record Updates

• Last Update Posted (Actual): July 24, 2024
• Last Update Submitted That Met QC Criteria: July 22, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: Cardiac Surgical Procedures; Heart Valve Prosthesis Implantation; Cardiac Diseases; Cardiovascular Surgical Procedures; Biosignal data
• Other Study ID Numbers: 4-2018-1002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

IPD Plan Description

Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be shared.

Start and end dates: Beginning 6 months and ending 36 months following article publication.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No