Diagnosis, Incidence and Consequences of PACU-Delirium

Study Overview
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Brief Summary
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This study aims to determine sensitivity and specificity of the Confusion Assessment Method for Postanesthesia Care Unit (CAM-PACU) examine the effect of postanesthesia care unit delirium (PACU delirium) on the emergence of later onset postoperative delirium (POD) as well as cognitive recovery until one month postoperatively

Official Title
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Diagnosis, Incidence and Consequences of Postoperative Delirium in Elderly Patients in the Post-anaesthetic Care Unit

Conditions
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Postoperative Delirium, Elderly Patient, Cognitive Decline

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: planned surgery in the near future surgery time at least 60min Exclusion Criteria: intracranial surgery expected postoperative transfer to ICU and stay exceeding 24h length of postoperative stay in hospital below 24h insufficient German language skills current alcohol or drug misuse manifest mental illness

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1 - Validation<br>Group 1 will be screened for delirium during the PACU stay using the CAM-PACU. Delirium criteria as defined by ICD-10 will be assessed in comparison. A subgroup of patients will receive an additional delirium screening using the CAM-PACU. This screening will be performed by another operator blinded for the results from the initial delirium screening. | |
| 2 - Cognition<br>Group 2 will be screened for delirium during the PACU stay using the CAM-PACU. Delirium criteria as defined by ICD-10 will be assessed in comparison. This group will undergo additional assessment of preoperative and postoperative cognitive function as well as a POD screening using the 3D-CAM starting at postoperative day 1 until discharge from hospital but no longer than postoperative day 5. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Group 1: Sensitivity and specificity of Confusion Assessment Method - Postanesthetic Care Unit (CAM-PACU) | in reference to International Classification of Diseases-Version 10 (ICD-10) | 15-240 minutes postoperatively | 
| Group 2: postoperative delirium after discharge from Postanesthetic Care Unit | 3D CAM and/or medical record | 0-5 days postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| re-test reliability | CAM-PACU | 15-240 minutes postoperatively | 
| cognitive performance | Montreal Cognitive Assessment (MoCA, 0-30 points, higher score = better outcome), Cognitive Telephone Screening Instrument (COGTEL), Patient Reported Outcomes Measurement Information System (PROMIS Neuro QoL) | before, 7 and 30 days postoperatively | 
| postoperative complications | European Perioperative Clinical Outcome (EPCO) definitions; Standardised Endpoints in Perioperative Medicine - Core Outcome Measures in Perioperative and Anaesthetic Care (Step-COMPAC) definitions | 30 days postoperatively | 
| feasibility of delirium screening by questioning of medical staff | self-designed questionnaire | before, 3 and 12 months after implementation of CAM-PACU | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Post-anesthetic care, Cognitive recovery, Delirium