Postoperative Delirium (POD)NCT05639348
Validation of a Risk Assessment Model for Postoperative Delirium Based on Artificial Intelligence
An observational study of Postoperative Delirium (POD), run by University Hospital, Basel, Switzerland at 3 sites in Switzerland.
Trial summary
Postoperative delirium (POD) is a frequent postoperative complication in the elderly, characterised by fluctuating disturbances in attention, awareness, and cognition. Identifying the patients at highest risk of developing POD was the aim of the artificial intelligence (AI)-based algorithm PIPRA. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Postoperative Delirium (POD)
- What is being tested?
- Data collection on POD for calculation of the PIPRA score
- How many people
- 993 participants
- Where
- 3 sitesSwitzerland
- Study dates
- 21 Nov 2022to 15 Jun 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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: Consecutive surgical patients at multiple sites in Switzerland.
Who may be able to join
- Surgical patients ≥60 years old
- Planned postoperative hospital stay ≥ 2 days
- Consent from patient
Who cannot join
- Preoperative delirium
- Insufficient knowledge in German or French
- Intracranial surgery
- Cardiac surgery
- Surgery within the two previous weeks
- Patient unable to consent
Trial locations and contacts
3 sites in 1 country.
Switzerland3 sites
University Hospital Basel, Anaesthesiology
Basel, 4031
Hôpitaux Universitaires de Genève, Anesthesiology
Geneva, 1205
Centre Hospitalier Universitaire Vaudois, Anesthesiology
Lausanne, 1011
About this study
Postoperative delirium (POD) is a frequent postoperative complication in the elderly, characterised by fluctuating disturbances in attention, awareness, and cognition. Identifying the patients at highest risk of developing POD was the aim of the artificial intelligence (AI)-based algorithm PIPRA. This prospective cohort study is to externally validate the AI-based PIPRA algorithm. The primary endpoint is the performance (AUC) of the PIPRA algorithm in predicting POD. The secondary endpoint is the performance (AUC) of the clinicians in predicting POD (and how it compares with the performance of the PIPRA algorithm).
Read the detailed description
Perioperative neurocognitive disorders (PND) include postoperative delirium (POD) and postoperative neurocognitive disorder or postoperative cognitive dysfunction (POCD). POD is recognised as a frequent postoperative complication in the elderly, occurring in 10% to 50% of older patients after major surgical procedures. POD usually occurs in the early postoperative period and is defined as an acute neuropsychiatric disorder. It is characterised by fluctuating disturbances in attention, awareness, and cognition. The American Society of Enhanced Recovery and Perioperative Quality Initiative Joint Consensus Statement on Postoperative Delirium Prevention recommend focusing on identifying those patients at highest risk of developing POD. Identifying these highest risk patients was the aim of the artificial intelligence (AI)-based algorithm PIPRA, which was created based on an individual participant data (IPD) meta-analysis including more than 2500 patients. This risk-prediction algorithm uses standard data (i.e. age, height, weight, history of delirium, cognitive impairment, ASA status, number of medications, preoperative C reactive protein (CRP), surgical risk and laparotomy), which are routinely collected before surgery. PIPRA was internally validated with an area under the curve (AUC) of 0.837 with 95% confidence interval 0.808 to 0.865, when plotting the true positive rate against the false positive rate. The aim of this prospective cohort study is to externally validate the AI-based PIPRA algorithm.
First, the anaesthesiologist in charge will be asked to evaluate, based on his/her experience (quantified in years of anaesthesia practice), the risk for the included patient to develop POD (categorised as low, intermediate, high or very high). Next, an investigator will assess included patents in a systematic and reproductible manner. After surgery, an investigator will visit the patient twice daily from postoperative day 1 to 5 or until hospital discharge (whichever occurs first) to screen for delirium using the 4AT or the ICDSC. The PIPRA score will be calculated separately by the coordinating study centre.
- Conditions
- Postoperative Delirium (POD)
- Being tested
- Data collection on POD for calculation of the PIPRA score
- Keywords
- Perioperative neurocognitive disorders (PND), Postoperative cognitive dysfunction (POCD), Acute neuropsychiatric disorder, Cognitive testing, Artificial intelligence (AI)-based algorithm PIPRA, Intensive Care Delirium Screening Checklist (ICDSC), 4 "A" Tests (4AT)
- Medical subject headings
- Emergence Delirium, Postoperative Cognitive Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Data collection on POD for calculation of the PIPRA scoreOther
Data collection for presence of POD as diagnosed by the 4 "A" Tests (4AT) or the Intensive Care Delirium Screening Checklist (ICDSC). The collected data will be used to validate the existing PIPRA algorithm and to improve the algorithm and evaluate it in a cross-validation setting. For the model validation the area under the receiver operating characteristics (ROC) curve (AUC) will be computed.
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in 4 'A's Test (4AT) to evaluate presence of POD
4 'A's Test (4AT) is a bedside medical scale with 4 parameters:
- Alertness
- Abbreviated mental test-4 (AMT4)
- Attention (months backwards test)
- Acute change or fluctuating course. The score range is 0-12, with scores of 4 or more suggesting possible delirium. Scores of 1-3 suggest possible cognitive impairment.
Measured: Twice daily (morning and evening) from postoperative day 1 until postoperative day 5, hospital discharge or a positive diagnosis of POD, whichever occurs first.
Change in Intensive Care Delirium Screening Checklist (ICDSC) to evaluate presence of POD
The ICDSC is an 8-item delirium screening instrument (range: 0-8 points) that evaluates a patient's level of consciousness, inattention, disorientation, hallucinations or delusions, psychomotor activity, inappropriate speech or mood, sleep disturbance and fluctuation of symptoms (no delirium with a score of 0, less than clinical threshold symptoms of delirium with a score of 1-3 and clinical delirium with a score of 4-8).
Measured: Twice daily (morning and evening) from postoperative day 1 until postoperative day 5, hospital discharge or a positive diagnosis of POD, whichever occurs first.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2022
- Study start21 Nov 2022
- Primary completion15 Jun 2024
- Study completion15 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Delirium (POD)Studies 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
- 993 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Collaborators
- Innosuisse - Swiss Innovation Agency
- Responsible party
- Sponsor
- Investigators
- Luzius Steiner, Prof. Dr. med., Principal investigator, University Hospital Basel, Department of Anaesthesiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05639348
- Sponsor's protocol ID
- 2022-00990; am21Dell- Kuster
- Status last verified
- Dec 2024
- First submitted
- 23 Nov 2022
- Last updated
- 18 Dec 2024
- 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 18 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of a Risk Assessment Model for Postoperative Delirium Based on Artificial Intelligence
- ClinicalTrials.gov ID
- NCT05639348
- Acronym / sponsor ID
- 2022-00990; am21Dell- Kuster
- Conditions
- Postoperative Delirium (POD)
- Keywords
- Perioperative neurocognitive disorders (PND), Postoperative cognitive dysfunction (POCD), Acute neuropsychiatric disorder, Cognitive testing, Artificial intelligence (AI)-based algorithm PIPRA, Intensive Care Delirium Screening Checklist (ICDSC), 4 "A" Tests (4AT)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 993 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Collaborators
- Innosuisse - Swiss Innovation Agency
- Study start
- 21 Nov 2022 (actual)
- Primary completion
- 15 Jun 2024 (actual)
- Study completion
- 15 Jun 2024 (actual)
- First posted
- 6 Dec 2022 (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.
Postoperative delirium (POD) is a frequent postoperative complication in the elderly, characterised by fluctuating disturbances in attention, awareness, and cognition. Identifying the patients at highest risk of developing POD was the aim of the artificial intelligence (AI)-based algorithm PIPRA. This prospective cohort study is to externally validate the AI-based PIPRA algorithm. The primary endpoint is the performance (AUC) of the PIPRA algorithm in predicting POD. The secondary endpoint is the performance (AUC) of the clinicians in predicting POD (and how it compares with the performance of the PIPRA algorithm).
Detailed description
Perioperative neurocognitive disorders (PND) include postoperative delirium (POD) and postoperative neurocognitive disorder or postoperative cognitive dysfunction (POCD). POD is recognised as a frequent postoperative complication in the elderly, occurring in 10% to 50% of older patients after major surgical procedures. POD usually occurs in the early postoperative period and is defined as an acute neuropsychiatric disorder. It is characterised by fluctuating disturbances in attention, awareness, and cognition. The American Society of Enhanced Recovery and Perioperative Quality Initiative Joint Consensus Statement on Postoperative Delirium Prevention recommend focusing on identifying those patients at highest risk of developing POD. Identifying these highest risk patients was the aim of the artificial intelligence (AI)-based algorithm PIPRA, which was created based on an individual participant data (IPD) meta-analysis including more than 2500 patients. This risk-prediction algorithm uses standard data (i.e. age, height, weight, history of delirium, cognitive impairment, ASA status, number of medications, preoperative C reactive protein (CRP), surgical risk and laparotomy), which are routinely collected before surgery. PIPRA was internally validated with an area under the curve (AUC) of 0.837 with 95% confidence interval 0.808 to 0.865, when plotting the true positive rate against the false positive rate. The aim of this prospective cohort study is to externally validate the AI-based PIPRA algorithm.
First, the anaesthesiologist in charge will be asked to evaluate, based on his/her experience (quantified in years of anaesthesia practice), the risk for the included patient to develop POD (categorised as low, intermediate, high or very high). Next, an investigator will assess included patents in a systematic and reproductible manner. After surgery, an investigator will visit the patient twice daily from postoperative day 1 to 5 or until hospital discharge (whichever occurs first) to screen for delirium using the 4AT or the ICDSC. The PIPRA score will be calculated separately by the coordinating study centre.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive surgical patients at multiple sites in Switzerland.
Key inclusion criteria (3 listed)
- Surgical patients ≥60 years old
- Planned postoperative hospital stay ≥ 2 days
- Consent from patient
Key exclusion criteria (6 listed)
- Preoperative delirium
- Insufficient knowledge in German or French
- Intracranial surgery
- Cardiac surgery
- Surgery within the two previous weeks
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 |
|---|---|---|
| Data collection on POD for calculation of the PIPRA scoreData collection for presence of POD as diagnosed by the 4 "A" Tests (4AT) or the Intensive Care Delirium Screening Checklist (ICDSC). The collected data will be used to validate the existing PIPRA algorithm and to improve the algorithm and evaluate it in a cross-validation setting. For the model validation the area under the receiver operating characteristics (ROC) curve (AUC) will be computed. | Other | – |
Primary outcome
Change in 4 'A's Test (4AT) to evaluate presence of POD
Time frame: Twice daily (morning and evening) from postoperative day 1 until postoperative day 5, hospital discharge or a positive diagnosis of POD, whichever occurs first.
4 'A's Test (4AT) is a bedside medical scale with 4 parameters: 1. Alertness 2. Abbreviated mental test-4 (AMT4) 3. Attention (months backwards test) 4. Acute change or fluctuating course. The score range is 0-12, with scores of 4 or more suggesting possible delirium. Scores of 1-3 suggest possible cognitive impairment.
Change in Intensive Care Delirium Screening Checklist (ICDSC) to evaluate presence of POD
Time frame: Twice daily (morning and evening) from postoperative day 1 until postoperative day 5, hospital discharge or a positive diagnosis of POD, whichever occurs first.
The ICDSC is an 8-item delirium screening instrument (range: 0-8 points) that evaluates a patient's level of consciousness, inattention, disorientation, hallucinations or delusions, psychomotor activity, inappropriate speech or mood, sleep disturbance and fluctuation of symptoms (no delirium with a score of 0, less than clinical threshold symptoms of delirium with a score of 1-3 and clinical delirium with a score of 4-8).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2024.
Related trials for Postoperative Delirium (POD)
Not yet recruiting
Prediction and Prevention of Postoperative Mortality and Morbidity
Dementia, Postoperative Delirium (POD)
Not yet recruitingObservational study
Comparison of IV Dexmedetomidine Versus Clonidine Versus no Alpha 2 Agonist on Emergency Delirium, PACU Length of Stay and Time to Hospital Discharge in Children Undergoing (Adeno)Tonsillectomy: a Prospective Observational Study
Emergency Delirium, Postoperative Delirium (POD)
Recruiting
Low Pneumoperitoneum Pressure for Delirium Prevention in Elderly Laparoscopy
Postoperative Delirium (POD), Intracranial Hypertension
Not yet recruitingPhase 4
Effects of Remimazolam on Postoperative Cognitive Dysfunction and Neuroinflammatory Biomarkers in Patients Undergoing Aortic Arch Surgery
Aortic Aneurysm of the Proximal Arch, Aortic Aneurysms Arch
RecruitingObservational study
Immunonutrition and Neuromonitoring for Postoperative Delirium in Gynecologic Oncology
Postoperative Delirium (POD), Gynecologic Cancers
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. This study is not recruiting at the moment.
Luzius Steiner, Prof. Dr. med. principal investigator
University Hospital Basel, Department of Anaesthesiology
3 sites 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 (POD), run by University Hospital, Basel, Switzerland at 3 sites 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 3 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: finished, as of the sponsor's last update on 18 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in 4 'A's Test (4AT) to evaluate presence of POD (time frame: Twice daily (morning and evening) from postoperative day 1 until postoperative day 5, hospital discharge or a positive diagnosis of POD, whichever occurs first.). The study lists 2 primary outcomes in all. 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 18 Dec 2024.