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

Recruiting

• Conditions: Cardiac Anaesthesia

• Registration Number: NCT04833751
• Lead Sponsor: Yonsei University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-12-14
• Study First Submitted: 2021-04-01
• Study First Submitted QC: 2021-04-05
• Study First Posted: 2021-04-06
• Status Verified: 2024-06
• Last Update Submitted: 2024-07-22
• Last Update Posted: 2024-07-24
• Primary Completion: 2028-12-31
• Study Completion: 2028-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 10000

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
all cause mortality	one year after surgery	All-cause mortality within one year after surgery

Secondary Outcome Measures

Name	Time	Method
deep sternal wound infection	within 30 days (±3 days) after surgery	infection involving muscle, bone, or mediastinum requiring operative intervention
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
prolonged mechanical ventilation	within 30 days (±3 days) after surgery	intubation required for more than 24 hours
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
Postprocedural myocardial infarction	within 2days after surgery	Defined by an increase in CK-MB or cardiac troponin (cTn) levels.
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.
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

Trial Locations

Locations (1)

Yonsei University Health System, Severance Hospital; 🇰🇷 Seoul, Korea, Republic of