Diagnosis, Incidence and Consequences of PACU-Delirium (PADE-DIC)

February 19, 2025 updated by: Universitätsklinikum Hamburg-Eppendorf

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

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

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

450

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Hamburg, Germany, 20251
        • Hamburg University Medical Centre Eppendorf

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients meeting inclusion criteria and presenting for sheduled surgery at the University Medical Centre Hamburg, Germany.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
1 - Validation
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

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?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Group 1: Sensitivity and specificity of "Confusion Assessment Method - Postanesthetic Care Unit" (CAM-PACU)
Time Frame: 15-240 minutes postoperatively
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
Time Frame: 0-5 days postoperatively
3D CAM and/or medical record
0-5 days postoperatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
re-test reliability
Time Frame: 15-240 minutes postoperatively
CAM-PACU
15-240 minutes postoperatively
cognitive performance
Time Frame: 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)
before, 7 and 30 days postoperatively
postoperative complications
Time Frame: 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
30 days postoperatively
feasibility of delirium screening by questioning of medical staff
Time Frame: before, 3 and 12 months after implementation of CAM-PACU
self-designed questionnaire
before, 3 and 12 months after implementation of CAM-PACU

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitätsklinikum Hamburg-Eppendorf

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 29, 2021

Primary Completion (Actual)

September 30, 2023

Study Completion (Actual)

August 1, 2024

Study Registration Dates

First Submitted

June 25, 2021

First Submitted That Met QC Criteria

July 18, 2021

First Posted (Actual)

July 27, 2021

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 19, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020-10331-BO-ff

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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