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

NCT04833751 | Recruiting

• 1 other identifier: 4-2018-1002
• Study Type: observational
• Target: 10,000
• Locations: 1 country
• Sites: 1

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. 1.Preoperative patient assessment
2. 2.All monitored perioperative biosignal data
3. 3.Intraoperative and immediate postoperative hemodynamic information, input/output balance, and medication usage
4. 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.

Conditions

Cardiac Anaesthesia

Keywords

Cardiac Diseases; Biosignal data; Cardiac Surgical Procedures; Cardiovascular Surgical Procedures; Heart Valve Prosthesis Implantation

Outcome Measures

Primary Outcomes (1)

• all cause mortality

  All-cause mortality within one year after surgery

  one year after surgery

Secondary Outcomes (7)

• Postprocedural myocardial infarction

  within 2days after surgery

• Acute kidney injury

  within 7days after surgery

• surgical re-exploration

  within 30 days (±3 days) after surgery

• deep sternal wound infection

  within 30 days (±3 days) after surgery

• prolonged mechanical ventilation

  within 30 days (±3 days) after surgery

Study Arms (1)

Anesthesia for cardiovascular surgery or procedure

Patients undergoing anesthesia in an operating room or hybrid room for cardiovascular surgery or procedure.

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing cardio/neurovascular surgery or procedure

You may qualify if:

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

You may not qualify if:

• \) 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

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Yonsei University Health System, Severance Hospital

Seoul, South Korea

RECRUITING

MeSH Terms

Conditions

Heart Diseases

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Study Officials

• Sarah Soh, MD, PhD

  Department of Anesthesiology and Pain Medicine, Yonsei Cardiovascular Hospital, Yonsei University College of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sarah Soh, MD, PhD

CONTACT

82-2-2228-8512; yeonchoo@yuhs.ac

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2021
• First Posted: April 6, 2021
• Study Start: December 14, 2018
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: July 24, 2024

Record last verified: 2024-06

Locations

KR (1)