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Recruiting NCT04833751

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

Observational Cardiac Anaesthesia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Cardiac Anaesthesia. Basic parameters: from 19 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
South Korea
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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

Overview

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.

Primary outcome measures

  • all cause mortality [Time frame: one year after surgery]
Secondary outcome measures (7)
  • Postprocedural myocardial infarction [Time frame: within 2days after surgery]
  • Acute kidney injury [Time frame: within 7days after surgery]
  • surgical re-exploration [Time frame: within 30 days (±3 days) after surgery]
  • deep sternal wound infection [Time frame: within 30 days (±3 days) after surgery]
  • prolonged mechanical ventilation [Time frame: within 30 days (±3 days) after surgery]
  • stroke/cerebrovascular accident [Time frame: within 30 days (±3 days) after surgery]
  • Readmission rate [Time frame: within 30days of the date of discharge from the index cardiac surgery hospitalization]

Eligibility criteria

Inclusion criteria

  • Adults age 19 and older
  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

South Korea · 1 center
  • Yonsei University Health System, Severance Hospital — Seoul

Identifiers

NCT: NCT04833751 · 4-2018-1002

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗