Validation of a Risk Assessment Model for Postoperative Delirium Based on Artificial Intelligence

Postoperative Delirium (POD) Clinical Trial

Official title:

Validation of a Risk Assessment Model for Postoperative Delirium Based on Artificial Intelligence

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05639348
• Other study ID #: 2022-00990; am21Dell- Kuster
• Status: Recruiting
• Start date: November 21, 2022
• Est. completion date: September 2024

Study information

• Verified date: February 2024
• Source: University Hospital, Basel, Switzerland
• Contact: Luzius Steiner, Prof. Dr. med.
• Phone: +41 61 265 73 20
• Email: luzius.steiner[@]usb.ch
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 950
• Est. completion date: September 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

Inclusion Criteria:

• Surgical patients =60 years old

• Planned postoperative hospital stay = 2 days

• Consent from patient

Exclusion Criteria:

• Preoperative delirium

• Insufficient knowledge in German or French

• Intracranial surgery

• Cardiac surgery

• Surgery within the two previous weeks

• Patient unable to consent

Related Conditions & MeSH terms

• Delirium
• Emergence Delirium
• Postoperative Delirium (POD)

Intervention

Other:
• Data collection on POD for calculation of the PIPRA score
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.

Locations

Country	Name	City	State
Switzerland	University Hospital Basel, Anaesthesiology	Basel
Switzerland	Hôpitaux Universitaires de Genève, Anesthesiology	Genève
Switzerland	Centre Hospitalier Universitaire Vaudois, Anesthesiology	Lausanne

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland	Innosuisse - Swiss Innovation Agency

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Twice daily (morning and evening) from postoperative day 1 until postoperative day 5, hospital discharge or a positive diagnosis of POD, whichever occurs first.
Primary	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).	Twice daily (morning and evening) from postoperative day 1 until postoperative day 5, hospital discharge or a positive diagnosis of POD, whichever occurs first.