Diagnosis, Incidence and Consequences of PACU-Delirium

Completed

• Conditions: Postoperative Delirium; Elderly Patient; Cognitive Decline

• Registration Number: NCT04978870
• Lead Sponsor: Universitätsklinikum Hamburg-Eppendorf

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-06-25
• Study First Submitted QC: 2021-07-18
• Study First Posted: 2021-07-27
• Study Start: 2021-07-29
• Primary Completion: 2023-09-30
• Study Completion: 2024-08-01
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-19
• Last Update Posted: 2025-02-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 450

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
cognitive performance	before, 7 and 30 days postoperatively	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)
re-test reliability	15-240 minutes postoperatively	CAM-PACU
postoperative complications	30 days postoperatively	European Perioperative Clinical Outcome (EPCO) definitions; Standardised Endpoints in Perioperative Medicine - Core Outcome Measures in Perioperative and Anaesthetic Care (Step-COMPAC) definitions
feasibility of delirium screening by questioning of medical staff	before, 3 and 12 months after implementation of CAM-PACU	self-designed questionnaire

Trial Locations

Locations (1)

Hamburg University Medical Centre Eppendorf; 🇩🇪 Hamburg, Germany