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NCT Number: NCT04833751

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

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.

Recruiting

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Key information

Conditions

Cardiac Anaesthesia Cardiovascular Diseases Heart Diseases

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Yonsei University Health System, Severance Hospital

Seoul, South Korea

Location status: Recruiting

Location contact

Sarah Soh, MD. PhD

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

Primary outcomes

  1. all cause mortality

    Time frame: one year after surgery

    All-cause mortality within one year after surgery

Secondary outcomes

  1. Postprocedural myocardial infarction

    Time frame: within 2days after surgery

    Defined by an increase in CK-MB or cardiac troponin (cTn) levels.

  2. Acute kidney injury

    Time frame: 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.

  3. surgical re-exploration

    Time frame: 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

  4. deep sternal wound infection

    Time frame: within 30 days (±3 days) after surgery

    infection involving muscle, bone, or mediastinum requiring operative intervention

  5. prolonged mechanical ventilation

    Time frame: within 30 days (±3 days) after surgery

    intubation required for more than 24 hours

  6. stroke/cerebrovascular accident

    Time frame: within 30 days (±3 days) after surgery

    Confirmed neurological deficit caused by a blood supply disturbance to the brain lasting more than 24 hours

  7. Readmission rate

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Sarah Soh, MD, PhD

CONTACT

[email protected]

82-2-2228-8512

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2028
Study completion
2028
First posted
Apr 6, 2021
Registry last updated
Jul 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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