Postoperative DeliriumCogCheck-ValidNCT03360838
Development of a Prediction Model for Delirium After Cardiac Surgery Using a Novel Self-Administered Preoperative Cognitive Assessment Tool
An observational study of Postoperative Delirium and Postoperative Cognitive Dysfunction, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial summary
This observational cohort study is designed to validate the CogCheck application as a risk prediction tool for postoperative delirium in patients undergoing cardiac surgery. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Postoperative Delirium, Postoperative Cognitive Dysfunction, Cognitive Decline
- What is being tested?
- CogCheck
- How many people
- 475 participants
- Where
- 1 siteSwitzerland
- Study dates
- 16 Apr 2018to Dec 2025
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing elective cardiac surgery are assessed with the BrainCheckpreop tool during the routinely held preoperative anesthesia consultation.
Who may be able to join
- Elective cardiac surgery
- Age ≥60 years
- Good knowledge of the German language
- Written informed consent
Who cannot join
- Emergency surgery
- Medical instability limiting preoperative assessment
- Surgical procedures without the use of cardiopulmonary bypass
- Procedures involving deep hypothermic circulatory arrest
- Concurrent carotid surgical procedures
- Participation in an interventional trial with POD or POCD as primary endpoint
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
University Hospital Basel
Basel, 4031
Nicolai Goettel, MD, +41 61 556 5228, nicolai.goettel@usb.ch
About this study
This observational cohort study is designed to validate the CogCheck application as a risk prediction tool for postoperative delirium in patients undergoing cardiac surgery.
Read the detailed description
Elderly patients undergoing surgery are more vulnerable to adverse postoperative outcomes due to advanced age, frailty, and concomitant medical conditions. Adverse cognitive outcomes such as postoperative delirium (POD) and postoperative cognitive dysfunction (POCD) are frequently encountered in older surgical patients, and are associated with increased morbidity and mortality. Since there is no simple and effective way to treat POD and/or POCD once they have occurred, prevention may be the key. Previous research has shown that delirium may be partially prevented using multicomponent risk intervention strategies. These prophylactic measures are best targeted at high-risk individuals. While most risk factors for POD and POCD may be detected in the medical history, clinical examination, or laboratory investigations, some may be missed in the absence of a specific assessment. Pre-existing cognitive impairment in surgical patients is one of the strongest risk factors for further postoperative cognitive decline including POD and POCD. However, it tends to be underdiagnosed, because an objective evaluation of the cognitive performance is time-consuming and usually requires trained personnel. At present, risk prediction models for POD after cardiac surgery either lack internal and external validation, use only brief cognitive assessments, and/or do not include cognitive functions at all.
In 2014, we developed a self-administered tablet computer program for the iPad (CogCheck) to assess the patient's individual risk for adverse postoperative cognitive outcomes. User-friendliness of the CogCheck application was tested in 20 cognitively healthy and 13 cognitively impaired volunteers, as well as in 47 patients undergoing surgery. In addition, normative data for the CogCheck tool have been generated in a previous study with 283 healthy volunteers. Respecting the continuing allocation of limited resources, the tool is self-explanatory and concise with a mean (SD) administration time in healthy participants of 21.7 (2.2) minutes.
POD occurs predominantly after cardiac surgery, with a reported incidence between 6% and 56%.
The aim of this observational study is to validate the use of the CogCheck application as a risk prediction tool for postoperative delirium in patients undergoing cardiac surgery.
Data are gathered from patients undergoing cardiac surgery at the University Hospital Basel. By comparing patients with and without POD, we will determine which subtests of the CogCheck tool best predict the occurrence of POD. Based on the final prediction model, risk profiles are created to facilitate the identification of patients that might benefit from preventive measures in the preoperative period.
- Conditions
- Postoperative Delirium, Postoperative Cognitive Dysfunction, Cognitive Decline, Cognitive Impairment, Cognition Disorders, Cardiac Surgery
- Being tested
- CogCheck
- Medical subject headings
- Emergence Delirium, Postoperative Cognitive Complications, Cognitive Dysfunction, Cognition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CogCheckOther
Performance of study participants in the application
| Study group | Role | What they receive |
|---|---|---|
| CogCheck application | Performance in the application Receives: Other: CogCheck |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative delirium
Postoperative delirium as defined by an Intensive Care Delirium Screening Checklist (ICDSC) score greater or equal to 4
Measured: Three times daily from postoperative day 1 until discharge from the intensive care unit (ICU) or intermediate care unit (IMC), assessed up to 50 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2017
- Study start16 Apr 2018
- Primary completionAug 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative DeliriumStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe 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
- 475 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Luzius Steiner, MD, PhD, Study chair, University Hospital, Basel, SwitzerlandNicolai Goettel, MD, Principal investigator, University Hospital, Basel, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03360838
- Sponsor's protocol ID
- CogCheck-Valid
- Acronym
- CogCheck-Valid
- Status last verified
- Jan 2025
- First submitted
- 27 Nov 2017
- Last updated
- 27 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Prediction Model for Delirium After Cardiac Surgery Using a Novel Self-Administered Preoperative Cognitive Assessment Tool
- ClinicalTrials.gov ID
- NCT03360838
- Acronym / sponsor ID
- CogCheck-Valid / CogCheck-Valid
- Conditions
- Postoperative Delirium, Postoperative Cognitive Dysfunction, Cognitive Decline, Cognitive Impairment, Cognition Disorders, Cardiac Surgery
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 475 participants (estimated)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- 16 Apr 2018 (actual)
- Primary completion
- Aug 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 4 Dec 2017 (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.
This observational cohort study is designed to validate the CogCheck application as a risk prediction tool for postoperative delirium in patients undergoing cardiac surgery.
Detailed description
Elderly patients undergoing surgery are more vulnerable to adverse postoperative outcomes due to advanced age, frailty, and concomitant medical conditions. Adverse cognitive outcomes such as postoperative delirium (POD) and postoperative cognitive dysfunction (POCD) are frequently encountered in older surgical patients, and are associated with increased morbidity and mortality. Since there is no simple and effective way to treat POD and/or POCD once they have occurred, prevention may be the key. Previous research has shown that delirium may be partially prevented using multicomponent risk intervention strategies. These prophylactic measures are best targeted at high-risk individuals. While most risk factors for POD and POCD may be detected in the medical history, clinical examination, or laboratory investigations, some may be missed in the absence of a specific assessment. Pre-existing cognitive impairment in surgical patients is one of the strongest risk factors for further postoperative cognitive decline including POD and POCD. However, it tends to be underdiagnosed, because an objective evaluation of the cognitive performance is time-consuming and usually requires trained personnel. At present, risk prediction models for POD after cardiac surgery either lack internal and external validation, use only brief cognitive assessments, and/or do not include cognitive functions at all.
In 2014, we developed a self-administered tablet computer program for the iPad (CogCheck) to assess the patient's individual risk for adverse postoperative cognitive outcomes. User-friendliness of the CogCheck application was tested in 20 cognitively healthy and 13 cognitively impaired volunteers, as well as in 47 patients undergoing surgery. In addition, normative data for the CogCheck tool have been generated in a previous study with 283 healthy volunteers. Respecting the continuing allocation of limited resources, the tool is self-explanatory and concise with a mean (SD) administration time in healthy participants of 21.7 (2.2) minutes.
POD occurs predominantly after cardiac surgery, with a reported incidence between 6% and 56%.
The aim of this observational study is to validate the use of the CogCheck application as a risk prediction tool for postoperative delirium in patients undergoing cardiac surgery.
Data are gathered from patients undergoing cardiac surgery at the University Hospital Basel. By comparing patients with and without POD, we will determine which subtests of the CogCheck tool best predict the occurrence of POD. Based on the final prediction model, risk profiles are created to facilitate the identification of patients that might benefit from preventive measures in the preoperative period.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CogCheck application | – | Other: CogCheckPerformance in the application |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing elective cardiac surgery are assessed with the BrainCheckpreop tool during the routinely held preoperative anesthesia consultation.
Key inclusion criteria (4 listed)
- Elective cardiac surgery
- Age ≥60 years
- Good knowledge of the German language
- Written informed consent
Key exclusion criteria (6 listed)
- Emergency surgery
- Medical instability limiting preoperative assessment
- Surgical procedures without the use of cardiopulmonary bypass
- Procedures involving deep hypothermic circulatory arrest
- Concurrent carotid surgical procedures
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CogCheckPerformance of study participants in the application | Other | CogCheck application |
Primary outcome
Postoperative delirium
Time frame: Three times daily from postoperative day 1 until discharge from the intensive care unit (ICU) or intermediate care unit (IMC), assessed up to 50 days
Postoperative delirium as defined by an Intensive Care Delirium Screening Checklist (ICDSC) score greater or equal to 4
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 27 Jan 2025.
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Dementia, Postoperative Delirium (POD)
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The Danish Out-of-Hospital Cardiac Arrest Study
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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.
Luzius Steiner, MD, PhD study chair
University Hospital, Basel, Switzerland
Nicolai Goettel, MD principal investigator
University Hospital, Basel, Switzerland
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 Postoperative Delirium and Postoperative Cognitive Dysfunction, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
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 4 inclusion and 6 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 27 Jan 2025. 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 Switzerland. 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 Nicolai Goettel, MD (+41 61 556 5228, nicolai.goettel@usb.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative delirium (time frame: Three times daily from postoperative day 1 until discharge from the intensive care unit (ICU) or intermediate care unit (IMC), assessed up to 50 days). 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 27 Jan 2025.