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

NCT03360838 | Recruiting

• 1 other identifier: CogCheck-Valid
• Study Type: observational
• Target: 475
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Postoperative Delirium; Postoperative Cognitive Dysfunction; Cognitive Decline; Cognitive Impairment; Cognition Disorders; Cardiac Surgery

Outcome Measures

Primary Outcomes (1)

• Postoperative delirium

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

  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

Study Arms (1)

CogCheck application

Performance in the application

Other: CogCheck

Interventions

CogCheck OTHER

Performance of study participants in the application

CogCheck application

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead

Study Sites (1)

University Hospital Basel

Basel, 4031, Switzerland

RECRUITING

MeSH Terms

Conditions

Emergence Delirium; Postoperative Cognitive Complications; Cognitive Dysfunction; Cognition Disorders

Condition Hierarchy (Ancestors)

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Study Officials

• Luzius Steiner, MD, PhD

  University Hospital, Basel, Switzerland

  STUDY CHAIR

• Nicolai Goettel, MD

  University Hospital, Basel, Switzerland

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nicolai Goettel, MD

CONTACT

+41 61 556 5228; nicolai.goettel@usb.ch

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 27, 2017
• First Posted: December 4, 2017
• Study Start: April 16, 2018
• Primary Completion: August 1, 2025
• Study Completion: December 1, 2025
• Last Updated: January 27, 2025

Record last verified: 2025-01

Locations

CH (1)