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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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
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

Other trials in South Korea

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.

  1. 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.

  1. First posted11 Apr 2022
  2. Study start17 Mar 2022
  3. Primary completion31 Dec 2023 (estimated)
  4. Study completion29 Feb 2024 (estimated)

Resources

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)
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

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.

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