Cognitive Decline Clinical Trial
— PADE-DICOfficial title:
Diagnosis, Incidence and Consequences of Postoperative Delirium in Elderly Patients in the Post-anaesthetic Care Unit
Verified date | December 2023 |
Source | Universitätsklinikum Hamburg-Eppendorf |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
This study aims to 1. determine sensitivity and specificity of the Confusion Assessment Method for Postanesthesia Care Unit (CAM-PACU) 2. 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
Status | Active, not recruiting |
Enrollment | 450 |
Est. completion date | September 2024 |
Est. primary completion date | September 30, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 65 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Germany | Hamburg University Medical Centre Eppendorf | Hamburg |
Lead Sponsor | Collaborator |
---|---|
Universitätsklinikum Hamburg-Eppendorf |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | Group 2: postoperative delirium after discharge from Postanesthetic Care Unit | 3D CAM and/or medical record | 0-5 days postoperatively | |
Secondary | re-test reliability | CAM-PACU | 15-240 minutes postoperatively | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | feasibility of delirium screening by questioning of medical staff | self-designed questionnaire | before, 3 and 12 months after implementation of CAM-PACU |
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