Emergence DeliriumMO-FA2-(TB)NCT07276503
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
An observational study of Emergence Delirium and Postoperative Delirium, run by University Hospital Tuebingen.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Emergence Delirium, Postoperative Delirium
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 9 Mar 2026to 30 May 2028
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: adult patients with Elective cardiac surgery Heart valve surgery, bypass surgery with CPB
Who may be able to join
- Elective cardiac surgery Heart valve surgery, bypass surgery with CPB
- Length of stay in ICU > 48 hours
- Age ≥18 years
- Fluent German language skills
Who cannot join
- Age <18 years
- Lack of capacity to give consent
- Emergency
- Readmission to intensive care unit
- OPCAB surgery, microsurgical procedure
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Predictors for the Development of Perioperative Delirium in Adult Patients Undergoing Elective Cardiac Surgery
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.
Read more
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
Read the detailed description
The data listed below is collected from the PDMS if the patient has been in the ICU for more than 48 hours.
Master data and pre-existing conditions Age (at admission) Case number Gender Diagnosis Cardiac ejection fraction in % Type of surgery According to surgical protocol Dementia yes/no Hearing aid yes/no Glasses yes/no Abuse: nicotine, alcohol, drugs Premedication with benzodiazepines yes/no
Preoperative data 4AT test Collected yes/no, four factors MO-FA2-(TB) Detailed score Geriatric check Collected yes/no, result Deviation of surgical planning from surgical program Difference in surgical sites Planned duration of surgery Minutes
Intraoperative data pO2 Percentage drop below induction values Acidosis yes/no Number of pH < 7.3; Lactateemia: max lactate concentration nmol/l Maximum in mmol/l Actual surgery duration Minutes Duration of heart-lung machine Minutes Blood loss Number of blood units administered Type of anesthesia TIVA yes/no; conduction anesthesia (spinal, EDC, block)
Data collection in ICU Diagnosis of delirium (date) Recorded daily by ICDSC and CAM-ICU Delirium score >50%/d pos. / not recorded Daily Days/hours of ventilation Total in hours NIV >3x1.5h yes/no Days of treatment in ICU Total for > 2 days of stay in ICU Place of discharge (recorded on day 28) IMC/general ward (+sitting guard)/ext. Hospital/Rehab/Home ventilation/Death Fluid intake 24h Liters daily Organ replacement therapy Dialysis / Plasmapheresis daily Tracheotomy Yes/no / Days with tracheostoma Singer Index Number (discharge) Day with acidosis (50% <7.35) Daily Sofa score Daily Pregabalin, esketamine, oxycodone Daily NRS/VAS score or BPS/external assessment Score 3x/d >3 / 3x "shows pain"/manipulation Benzodiazepines Total requirement in ICU in mg Haloperidol, clonidine, quetiapine, etc. Per cumulative dose in mg/d Other: Risperidone, Clozapine, Pipamperone Per cumulative dose in mg/day Organ replacement procedures (dialysis, ECMO, ECLS, plasmapheresis) Number of days after organ replacement procedure Deceased on day 28/transferred Transfer/type of discharge
- Conditions
- Emergence Delirium, Postoperative Delirium
- Keywords
- predicitve, delirium, postoperative, valve surgery, bypass surgery, Score, MO-FA2-(TB)
- Medical subject headings
- Emergence Delirium, Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| adults with elective valve or bypass surgery using heart-lung machine | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients after heart surgery with postoperative delirium
Relation between result of MO-FA2-(TB)-Score and actual development of postoperative delirium
Measured: from 48 hours ICU stay to day 10 of ICU stay or dismssal from ICU
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2025
- Study start9 Mar 2026 (estimated)
- Primary completion30 Nov 2027 (estimated)
- Study completion30 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Emergence DeliriumStudies of the same condition, open and under way.
- More trials run by University Hospital TuebingenThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Peter Rosenberger, Prof. Dr., Study director, Universitaetsklinikum Tuebingen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07276503
- Sponsor's protocol ID
- Verify-MO-FA2-(TB)
- Acronym
- MO-FA2-(TB)
- Status last verified
- Nov 2025
- First submitted
- 28 Nov 2025
- Last updated
- 6 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 30665435Wu 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.
PubMed 40828691
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictors for the Development of Perioperative Delirium in Adult Patients Undergoing Elective Cardiac Surgery
- ClinicalTrials.gov ID
- NCT07276503
- Acronym / sponsor ID
- MO-FA2-(TB) / Verify-MO-FA2-(TB)
- Conditions
- Emergence Delirium, Postoperative Delirium
- Keywords
- predicitve, delirium, postoperative, valve surgery, bypass surgery, Score, MO-FA2-(TB)
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Study start
- 9 Mar 2026 (estimated)
- Primary completion
- 30 Nov 2027 (estimated)
- Study completion
- 30 May 2028 (estimated)
- First posted
- 11 Dec 2025 (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.
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
Detailed description
The data listed below is collected from the PDMS if the patient has been in the ICU for more than 48 hours.
Master data and pre-existing conditions Age (at admission) Case number Gender Diagnosis Cardiac ejection fraction in % Type of surgery According to surgical protocol Dementia yes/no Hearing aid yes/no Glasses yes/no Abuse: nicotine, alcohol, drugs Premedication with benzodiazepines yes/no
Preoperative data 4AT test Collected yes/no, four factors MO-FA2-(TB) Detailed score Geriatric check Collected yes/no, result Deviation of surgical planning from surgical program Difference in surgical sites Planned duration of surgery Minutes
Intraoperative data pO2 Percentage drop below induction values Acidosis yes/no Number of pH < 7.3; Lactateemia: max lactate concentration nmol/l Maximum in mmol/l Actual surgery duration Minutes Duration of heart-lung machine Minutes Blood loss Number of blood units administered Type of anesthesia TIVA yes/no; conduction anesthesia (spinal, EDC, block)
Data collection in ICU Diagnosis of delirium (date) Recorded daily by ICDSC and CAM-ICU Delirium score >50%/d pos. / not recorded Daily Days/hours of ventilation Total in hours NIV >3x1.5h yes/no Days of treatment in ICU Total for > 2 days of stay in ICU Place of discharge (recorded on day 28) IMC/general ward (+sitting guard)/ext. Hospital/Rehab/Home ventilation/Death Fluid intake 24h Liters daily Organ replacement therapy Dialysis / Plasmapheresis daily Tracheotomy Yes/no / Days with tracheostoma Singer Index Number (discharge) Day with acidosis (50% <7.35) Daily Sofa score Daily Pregabalin, esketamine, oxycodone Daily NRS/VAS score or BPS/external assessment Score 3x/d >3 / 3x "shows pain"/manipulation Benzodiazepines Total requirement in ICU in mg Haloperidol, clonidine, quetiapine, etc. Per cumulative dose in mg/d Other: Risperidone, Clozapine, Pipamperone Per cumulative dose in mg/day Organ replacement procedures (dialysis, ECMO, ECLS, plasmapheresis) Number of days after organ replacement procedure Deceased on day 28/transferred Transfer/type of discharge
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| adults with elective valve or bypass surgery using heart-lung machine | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- adult patients with Elective cardiac surgery Heart valve surgery, bypass surgery with CPB
Key inclusion criteria (4 listed)
- Elective cardiac surgery Heart valve surgery, bypass surgery with CPB
- Length of stay in ICU > 48 hours
- Age ≥18 years
- Fluent German language skills
Key exclusion criteria (5 listed)
- Age <18 years
- Lack of capacity to give consent
- Emergency
- Readmission to intensive care unit
- OPCAB surgery, microsurgical procedure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of patients after heart surgery with postoperative delirium
Time frame: from 48 hours ICU stay to day 10 of ICU stay or dismssal from ICU
Relation between result of MO-FA2-(TB)-Score and actual development of postoperative delirium
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 6 Mar 2026.
- Background: PubMed 30665435Sanchez 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.
- Background: PubMed 40828691Wu 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.
- Individual participant dataSharing planned: No
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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.
Peter Rosenberger, Prof. Dr. study director
Universitaetsklinikum Tuebingen
Questions about this trial
What is this clinical trial studying?
An observational study of Emergence Delirium and Postoperative Delirium, run by University Hospital Tuebingen.
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 5 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: opening soon, as of the sponsor's last update on 6 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Christian Marx, B.A. (+4970712986724, christian.marx@med.uni-tuebingen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients after heart surgery with postoperative delirium (time frame: from 48 hours ICU stay to day 10 of ICU stay or dismssal from ICU). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07276503, which also lists 2 linked publications.
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 6 Mar 2026.