Cardiac AnaesthesiaNCT04833751
Registry of Cardio/Neurovascular Anesthesia Including the Database of Biological Signals During Anesthesia, Preoperative Assessment and Prognosis in Patients
An observational study of Cardiac Anaesthesia, run by Yonsei University at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Cardiac Anaesthesia
- How many people
- 10,000 participants
- Where
- 1 siteSouth Korea
- Study dates
- 14 Dec 2018to 31 Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing cardio/neurovascular surgery or procedure
Who may be able to join
- Adults age 19 and older
- Patients scheduled for anesthesia at a cardiovascular hospital for cardiovascular surgery or procedures
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Yonsei University Health System, Severance Hospital
Seoul
Sarah Soh, MD. PhD
About this study
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
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:
- Preoperative patient assessment
- All monitored perioperative biosignal data
- Intraoperative and immediate postoperative hemodynamic information, input/output balance, and medication usage
- 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
- Medical subject headings
- Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Anesthesia for cardiovascular surgery or procedure | Patients undergoing anesthesia in an operating room or hybrid room for cardiovascular surgery or procedure. |
What is being measured
The primary outcome is the main question the study is designed to answer.
all cause mortality
All-cause mortality within one year after surgery
Measured: one year after surgery
Secondary outcomes (7)
Postprocedural myocardial infarction
Defined by an increase in CK-MB or cardiac troponin (cTn) levels.
Measured: within 2days after surgery
Acute kidney injury
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.
Measured: within 7days after surgery
surgical re-exploration
require a return to the operating room for bleeding with or without tamponade, graft occlusion, valve dysfunction, or other cardiac reason
Measured: within 30 days (±3 days) after surgery
deep sternal wound infection
infection involving muscle, bone, or mediastinum requiring operative intervention
Measured: within 30 days (±3 days) after surgery
prolonged mechanical ventilation
intubation required for more than 24 hours
Measured: within 30 days (±3 days) after surgery
stroke/cerebrovascular accident
Confirmed neurological deficit caused by a blood supply disturbance to the brain lasting more than 24 hours
Measured: within 30 days (±3 days) after surgery
Readmission rate
readmission to an acute care hospital within 30 days of discharge from the cardiac surgery hospitalization
Measured: within 30days of the date of discharge from the index cardiac surgery hospitalization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2021
- Study start14 Dec 2018
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac AnaesthesiaStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sarah Soh, MD, PhD, Principal investigator, Department of Anesthesiology and Pain Medicine, Yonsei Cardiovascular Hospital, Yonsei University College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04833751
- Sponsor's protocol ID
- 4-2018-1002
- Status last verified
- Jun 2024
- First submitted
- 1 Apr 2021
- Last updated
- 24 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be shared. Start and end dates: Beginning 6 months and ending 36 months following article publication.
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04833751
- Acronym / sponsor ID
- 4-2018-1002
- Conditions
- Cardiac Anaesthesia
- Keywords
- Cardiac Diseases, Biosignal data, Cardiac Surgical Procedures, Cardiovascular Surgical Procedures, Heart Valve Prosthesis Implantation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 14 Dec 2018 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 6 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Preoperative patient assessment
- All monitored perioperative biosignal data
- Intraoperative and immediate postoperative hemodynamic information, input/output balance, and medication usage
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Anesthesia for cardiovascular surgery or procedure | – | –Patients undergoing anesthesia in an operating room or hybrid room for cardiovascular surgery or procedure. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing cardio/neurovascular surgery or procedure
Key inclusion criteria (2 listed)
- Adults age 19 and older
- Patients scheduled for anesthesia at a cardiovascular hospital for cardiovascular surgery or procedures
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
all cause mortality
Time frame: one year after surgery
All-cause mortality within one year after surgery
7 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2024.
- Individual participant dataSharing planned: Undecided. Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be shared. Start and end dates: Beginning 6 months and ending 36 months following article publication.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sarah Soh, MD, PhD principal investigator
Department of Anesthesiology and Pain Medicine, Yonsei Cardiovascular Hospital, Yonsei University College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Anaesthesia, run by Yonsei University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sarah Soh, MD, PhD (82-2-2228-8512, yeonchoo@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
all cause mortality (time frame: one year after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2024.