Adult Patients Undergoing Open Heart SurgeryNCT05320965
Prospective Validation of the Model Predicting Postoperative Delirium Occurrence With Machine Learning-based Analysis of Intraoperative Biological Signals During Anesthesia in Cardiac Surgery
An observational study of Adult Patients Undergoing Open Heart Surgery, run by Yonsei University at 1 site in South Korea.
Trial summary
Postoperative delirium (POD) not only increases the length of hospitalization and intensive care unit stay and medical costs, but is also closely associated with negative prognosis, including postoperative mortality, increased morbidity, long-term cognitive decline after surgery, and impaired quality of life and… Read more about this study
- Who is it for?
- Ages 19 to 100 years
- Conditions the study is for
- Adult Patients Undergoing Open Heart Surgery
- How many people
- 200 participants
- Where
- 1 siteSouth Korea
- Study dates
- 17 Mar 2022to 29 Feb 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients scheduled for heart/aorta surgery at a tertiary hospital
Who may be able to join
- Adults between 19 and 100 years of age
- Patients scheduled for cardiac or aortic surgery
Who cannot join
- Patients with a history of major neurocognitive disorder, major depressive disorder, and alcohol or drug dependence before surgery
- Patients who have already lost consciousness before surgery
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Yonsei University Health System, Severance Hospital
Seoul
About this study
Postoperative delirium (POD) not only increases the length of hospitalization and intensive care unit stay and medical costs, but is also closely associated with negative prognosis, including postoperative mortality, increased morbidity, long-term cognitive decline after surgery, and impaired quality of life and independence. The preoperative risk assessment and early detection of POD are very important in the proper management of POD. This is because drug treatment that can prevent or treat POD is limited, and for its prevention and management, a multidisciplinary approach and resource management covering almost all aspects of patient management are required. Therefore, if there is a model that can predict the occurrence of POD, it can be of great help in managing delirium after cardiac surgery through more accurate risk assessment and early detection. In previous studies, aging and cognitive decline before surgery are known as major risk factors for POD, but identification of risk factors before surgery alone is insufficient to predict the occurrence of POD. Cardiac surgery is highly likely to cause pathophysiological changes that can cause POD, because it is associated with hemodynamic instability, cardiopulmonary use, changes in body temperature, and systemic inflammatory response. These pathophysiological changes can be reflected in the data (biosignals) obtained through various monitoring devices during anesthesia. Most of the events that occur during anesthesia are considered to be correctable risk factors of POD, unlike preoperative risk factors, and there is a potential to reduce the occurrence of POD by actively correcting them. Therefore, it is necessary to analyze the effect of these intraoperative biosignals on POD. In the delirium prediction model development process, rather than simply dividing the already collected data and using it in the model performance validation process, it is better to conduct model performance validation based on patient data prospectively collected to prevent overfitting and achieve higher predictive performance. Therefore, this study aims to collect prospective data to evaluate the performance of the delirium prediction model after cardiac surgery built using machine learning techniques based on the already collected data including biosignals during anesthesia. After reviewing the medical records from the day of surgery to the period of stay in the ICU, if the Intensive Care Delirium Screening Checklist (ICDSC) score is 6 or higher or there is a record of consultation with delirium, it is recorded as POD. After structuring the database through purification, standardization, outlier detection, and sampling of biosignal data generated during surgery, various variables obtained from medical records are collected to construct an evaluation dataset. Using this dataset, the performance of the delirium prediction model built by applying the machine learning algorithm is evaluated through Receiver Operating Characteristic curve analysis.
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative delirium
The Intensive Care Delirium Screening Checklist (ICDSC) score is 6 or higher
Measured: up to 7 days post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2022
- Study start17 Mar 2022
- Primary completion31 Dec 2023 (estimated)
- Study completion29 Feb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adult Patients Undergoing Open Heart SurgeryStudies 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
- 200 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
- NCT05320965
- Sponsor's protocol ID
- 4-2022-0093
- Status last verified
- Apr 2022
- First submitted
- 3 Apr 2022
- Last updated
- 11 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Validation of the Model Predicting Postoperative Delirium Occurrence With Machine Learning-based Analysis of Intraoperative Biological Signals During Anesthesia in Cardiac Surgery
- ClinicalTrials.gov ID
- NCT05320965
- Acronym / sponsor ID
- 4-2022-0093
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 17 Mar 2022 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 29 Feb 2024 (estimated)
- First posted
- 11 Apr 2022 (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.
Postoperative delirium (POD) not only increases the length of hospitalization and intensive care unit stay and medical costs, but is also closely associated with negative prognosis, including postoperative mortality, increased morbidity, long-term cognitive decline after surgery, and impaired quality of life and independence. The preoperative risk assessment and early detection of POD are very important in the proper management of POD. This is because drug treatment that can prevent or treat POD is limited, and for its prevention and management, a multidisciplinary approach and resource management covering almost all aspects of patient management are required. Therefore, if there is a model that can predict the occurrence of POD, it can be of great help in managing delirium after cardiac surgery through more accurate risk assessment and early detection. In previous studies, aging and cognitive decline before surgery are known as major risk factors for POD, but identification of risk factors before surgery alone is insufficient to predict the occurrence of POD. Cardiac surgery is highly likely to cause pathophysiological changes that can cause POD, because it is associated with hemodynamic instability, cardiopulmonary use, changes in body temperature, and systemic inflammatory response. These pathophysiological changes can be reflected in the data (biosignals) obtained through various monitoring devices during anesthesia. Most of the events that occur during anesthesia are considered to be correctable risk factors of POD, unlike preoperative risk factors, and there is a potential to reduce the occurrence of POD by actively correcting them. Therefore, it is necessary to analyze the effect of these intraoperative biosignals on POD. In the delirium prediction model development process, rather than simply dividing the already collected data and using it in the model performance validation process, it is better to conduct model performance validation based on patient data prospectively collected to prevent overfitting and achieve higher predictive performance. Therefore, this study aims to collect prospective data to evaluate the performance of the delirium prediction model after cardiac surgery built using machine learning techniques based on the already collected data including biosignals during anesthesia. After reviewing the medical records from the day of surgery to the period of stay in the ICU, if the Intensive Care Delirium Screening Checklist (ICDSC) score is 6 or higher or there is a record of consultation with delirium, it is recorded as POD. After structuring the database through purification, standardization, outlier detection, and sampling of biosignal data generated during surgery, various variables obtained from medical records are collected to construct an evaluation dataset. Using this dataset, the performance of the delirium prediction model built by applying the machine learning algorithm is evaluated through Receiver Operating Characteristic curve analysis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 19 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients scheduled for heart/aorta surgery at a tertiary hospital
Key inclusion criteria (2 listed)
- Adults between 19 and 100 years of age
- Patients scheduled for cardiac or aortic surgery
Key exclusion criteria (2 listed)
- Patients with a history of major neurocognitive disorder, major depressive disorder, and alcohol or drug dependence before surgery
- Patients who have already lost consciousness before surgery
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
Postoperative delirium
Time frame: up to 7 days post-surgery
The Intensive Care Delirium Screening Checklist (ICDSC) score is 6 or higher
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2022.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
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 Adult Patients Undergoing Open Heart Surgery, 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 2 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: status not confirmed, as of the sponsor's last update on 11 Apr 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative delirium (time frame: up to 7 days post-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 11 Apr 2022.