Clinical trial NCT04833751: Registry of Cardio/Neurovascular Anesthesia Including the Database of Biological Signals During Anesthesia, Preoperative Assessment and Prognosis in Patients
Official title: Registry of Cardiovascular Anesthesia Including the Database of Biological Signals During Anesthesia, Preoperative Assessment and Prognosis in Patients: Severance Cardiovascular Surgery Prospective (SECURE) Database
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cardiac Anaesthesia
Keywords: Cardiac Diseases
Biosignal data
Cardiac Surgical Procedures
Cardiovascular Surgical Procedures
Heart Valve Prosthesis Implantation
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2021-04-06
Enrollment: 10000
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing cardio/neurovascular surgery or procedure

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.


Eligibility criteria: 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

Primary outcomes:
measure: all cause mortality
timeFrame: one year after surgery
Secondary outcomes:
measure: Postprocedural myocardial infarction
timeFrame: within 2days after surgery
measure: Acute kidney injury
timeFrame: within 7days after surgery
measure: surgical re-exploration
timeFrame: within 30 days (±3 days) after surgery
measure: deep sternal wound infection
timeFrame: within 30 days (±3 days) after surgery
measure: prolonged mechanical ventilation
timeFrame: within 30 days (±3 days) after surgery
measure: stroke/cerebrovascular accident
timeFrame: within 30 days (±3 days) after surgery
measure: Readmission rate
timeFrame: within 30days of the date of discharge from the index cardiac surgery hospitalization
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Yonsei University Health System, Severance Hospital
Study officials:
affiliation: Department of Anesthesiology and Pain Medicine, Yonsei Cardiovascular Hospital, Yonsei University College of Medicine
name: Sarah Soh, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: