Diagnosis, Incidence and Consequences of PACU-Delirium

NCT ID: NCT04978870

Last Updated: 2025-02-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

450 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-07-29

Study Completion Date

2024-08-01

Brief Summary

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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

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Conditions

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Postoperative Delirium Elderly Patient Cognitive Decline

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

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.

No interventions assigned to this group

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
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universitätsklinikum Hamburg-Eppendorf

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hamburg University Medical Centre Eppendorf

Hamburg, City state of Hamburg, Germany

Site Status

Countries

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Germany

Other Identifiers

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2020-10331-BO-ff

Identifier Type: -

Identifier Source: org_study_id

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