Verification of a New Predictive Delirium Score in Adults With Elective Cardiac Valve or Bypass Surgery With Perioperative Use of a Heart-lung Machine; a Monocentric Pilot Observational Study

NCT07276503 | Not Yet Recruiting

• 1 other identifier: Verify-MO-FA2-(TB)
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

Basics (state of scientific knowledge): Delirium is an acute disturbance of consciousness and attention that develops over a short period of time and fluctuates in severity. It is accompanied by a deterioration in cognitive performance, such as memory deficits, disorientation, and speech and thinking disorders, which significantly exceed the degree of any pre-existing limitations . Surgery and intensive medical treatment are considered to be two of the triggers. In cardiac surgery, the incidence is reported to be between 10 and 50%, depending on the patient population. Delirium occurs approximately 3-4 days after surgery and lasts for several days. Relevant factors in the cardiac surgery population include age, duration of aortic clamping time or surgical technique, pre-existing conditions such as the extent of heart failure (EuroScore), diabetes mellitus, mental and cognitive impairments, or carotid stenosis. Both current studies and current recommendations emphasize prevention and the lack of successful treatment options. Preventive measures are primarily investigated in packages of measures. The study presented here aims to define risk populations and test the sensitivity and specificity of the MO-FA2-(TB) score for the development of delirium. Objectives of the study: Verification of the predictive score "MO-FA2-(TB)" for the development of postoperative delirium Recording of delirium and associated influencing factors and endpoints Categories examined in the score: Memory using a list of words that must be memorized and repeated after a few minutes Orientation by asking about the year, month, date, day of the week, city, and location Frailty using the ASA score Use of heart-lung machine Incision-suture time Study duration (for individual subjects): postoperative intensive care stay up to and including day 10 Study population Patients who have to undergo cardiac surgery with CPB Inclusion criteria: Elective cardiac surgery Heart valve surgery, bypass surgery with CPB Length of stay in ICU \> 48 hours Age ≥18 years Fluent German language skills Exclusion criteria: Age \<18 years Lack of capacity to give consent Emergency Readmission to intensive care unit OPCAB surgery, microsurgical procedure Recruitment: Information provided the day before surgery based on the surgical schedule If consent is given, score is recorded If ICU stay \>48 hours, treatment data is recorded, otherwise exclusion Data collection up to and including d10 Treatment data collected: Preoperative data, including ejection fraction, aids, abuse, scores collected ("4AT test" for rapid assessment of delirium and cognitive impairment, "MO-FA2-(TB)", "geriatric check" for identifying a geriatric patient) Intraoperative data, including duration of surgery, duration of heart-lung machine, acidosis Postoperative data in ICU, including delirium scores (ICDSC, CAM-ICU), days on ventilation, days of treatment, fluid intake, medication related to delirium, organ replacement therapy such as dialysis Number of cases: Approx. 100 patients Methodology Monocentric, observation

Conditions

Postoperative Delirium; Emergence Delirium

Keywords

predicitve; delirium; postoperative; valve surgery; bypass surgery; Score; MO-FA2-(TB)

Outcome Measures

Primary Outcomes (1)

• Number of patients after heart surgery with postoperative delirium

  Relation between result of MO-FA2-(TB)-Score and actual development of postoperative delirium

  from 48 hours ICU stay to day 10 of ICU stay or dismssal from ICU

Study Arms (1)

adults with elective valve or bypass surgery using heart-lung machine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

adult patients with Elective cardiac surgery Heart valve surgery, bypass surgery with CPB

You may qualify if:

• Elective cardiac surgery Heart valve surgery, bypass surgery with CPB
• Length of stay in ICU \> 48 hours
• Age ≥18 years
• Fluent German language skills

You may not qualify if:

• Age \<18 years
• Lack of capacity to give consent
• Emergency
• Readmission to intensive care unit
• OPCAB surgery, microsurgical procedure

Sponsors & Collaborators

• University Hospital Tuebingen: lead

Related Publications (2)

• Sanchez A, Thomas C, Deeken F, Wagner S, Kloppel S, Kentischer F, von Arnim CAF, Denkinger M, Conzelmann LO, Biermann-Stallwitz J, Joos S, Sturm H, Metz B, Auer R, Skrobik Y, Eschweiler GW, Rapp MA; PAWEL Study group. Patient safety, cost-effectiveness, and quality of life: reduction of delirium risk and postoperative cognitive dysfunction after elective procedures in older adults-study protocol for a stepped-wedge cluster randomized trial (PAWEL Study). Trials. 2019 Jan 21;20(1):71. doi: 10.1186/s13063-018-3148-8.

  PMID: 30665435 BACKGROUND

• Wu SJ, Sharma N, Bauch A, Yang HC, Hect JL, Thomas C, Wagner S, Forstner BR, von Arnim CAF, Kaufmann T, Eschweiler GW, Wolfers T; PAWEL Study Group. Predicting Postoperative Delirium in Older Patients Before Elective Surgery: Multicenter Retrospective Cohort Study. JMIR Aging. 2025 Aug 19;8:e67958. doi: 10.2196/67958.

  PMID: 40828691 BACKGROUND

MeSH Terms

Conditions

Emergence Delirium; Delirium

Condition Hierarchy (Ancestors)

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

• Peter Rosenberger, Prof. Dr.

  Universitaetsklinikum Tuebingen

  STUDY DIRECTOR

Central Study Contacts

Christian Marx, B.A.

CONTACT

+4970712986724; christian.marx@med.uni-tuebingen.de

Study Design

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

Study Record Dates

• First Submitted: November 28, 2025
• First Posted: December 11, 2025
• Study Start: March 9, 2026
• Primary Completion (Estimated): November 30, 2027
• Study Completion (Estimated): May 30, 2028
• Last Updated: March 6, 2026

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share