ClinicalTrials.gg
RecruitingNCT03360838CogCheck-ValidUpdated Jan 27, 2025

Development of a Prediction Model for Delirium After Cardiac Surgery Using a Novel Self-Administered Preoperative Cognitive Assessment Tool

An observational study in Postoperative Delirium, Postoperative Cognitive Dysfunction and Cognitive Decline, sponsored by University Hospital, Basel, Switzerland. Recruiting at 1 site in Switzerland. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2025-01-27.

Sponsored by University Hospital, Basel, Switzerland · Observational

From the registry’s dates

  • Primary completion was expected by Aug 2025, 1 year 3 months ago, but the record still lists the study as recruiting.
  • Started Apr 2018; still recruiting 8 years 6 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
475
Ages
60 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 11 studies in Emergence Delirium with a site in Switzerland — 3 open to participants now, 3 under way, none of them phase 3. Emergence Delirium · Switzerland.

Started
2018
the only one that year
Observational
8 of 11
3 open now
Registered
8th of 11
by date
Lead sponsor
7 of 11
University Hospital, Basel, Switzerland

Among the 11 studies in Emergence Delirium with a site in Switzerland, this one is the only one that started in 2018, is one of 8 observational ones, and was the 8th registered.

Emergence Delirium

751 studies on the registry are indexed under Emergence Delirium; 262 are open to participants now.

Browse Emergence Delirium studies →

Open to participants now

3 of the 11 studies in Emergence Delirium with a site in Switzerland are open now. Recruiting first, the newest first:

All 3 open studies →

A study can be open while its sites in Switzerland have not opened yet or have stopped. Only those recruiting at a site in Switzerland →

Who these studies take

Of the 143 Emergence Delirium studies recruiting now, 78 (55%) set no upper age limit and 45 (31%) stop at 75 or younger; 35 take children under 18; 25 take healthy volunteers.

This study: 60 Years and older · all sexes · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

Was this useful?
Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 11 studies in Emergence Delirium with a site in Switzerland, or all of them as a file.
02

Study 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 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.

03

Conditions studied

  • Postoperative Delirium
  • Postoperative Cognitive Dysfunction
  • Cognitive Decline
  • Cognitive Impairment
  • Cognition Disorders
  • Cardiac Surgery
04

Who can participate

Ages eligible
60 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients undergoing elective cardiac surgery are assessed with the BrainCheckpreop tool during the routinely held preoperative anesthesia consultation.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Elective cardiac surgery
  • Age ≥60 years
  • Good knowledge of the German language
  • Written

Exclusion criteria

Exclusion Criteria:

  • 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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
475 participants (estimated)
Patient registry
No

Groups and cohorts

  • CogCheck application

    Performance in the application

    Other: CogCheck

Interventions

  • OtherCogCheck

    Performance of study participants in the application

06

What researchers measure

Primary outcomes

  1. Postoperative delirium

    Postoperative delirium as defined by an Intensive Care Delirium Screening Checklist (ICDSC) score greater or equal to 4

    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

07

Study locations

1 of 1 sites recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Apr 2018 (actual). Primary completion is estimated for Aug 2025, 88 months after the start.

Of 181 non-industry observational studies under Emergence Delirium, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 43. This study's planned 88 months is above that.

Counting every sponsor, half of 181 studies reached it within 21 months; a quarter within 10 and three quarters within 43.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 27, 2017
First posted
Dec 4, 2017
StartActual
Apr 16, 2018
Primary completionEst.
Aug 2025
CompletionEst.
Dec 2025
Last update
Jan 27, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 27, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03360838
Responsible party
Sponsor
First posted
Dec 4, 2017
Start date
Apr 16, 2018
Primary completion
Aug 2025 (estimated)
Completion
Dec 2025 (estimated)
Last update
Jan 27, 2025

Study contacts

Nicolai Goettel, MD
Contact
nicolai.goettel@usb.ch
+41 61 556 5228
Luzius Steiner, MD, PhD
study chair · University Hospital, Basel, Switzerland
Nicolai Goettel, MD
principal investigator · University Hospital, Basel, Switzerland

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion