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

U

Universitätsklinikum Hamburg-Eppendorf

Status

Completed

Conditions

Elderly Patient
Cognitive Decline
Postoperative Delirium

Study type

Observational

Funder types

Other

Identifiers

NCT04978870
2020-10331-BO-ff

Details and patient eligibility

About

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

Enrollment

450 patients

Sex

All

Ages

65+ years old

Volunteers

No Healthy Volunteers

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

Trial design

450 participants in 2 patient groups

1 - Validation
Description:
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
Description:
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.

Trial contacts and locations

1

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Central trial contact

Marlene Fischer, PD Dr; Cynthia IF Olotu, Dr

Data sourced from clinicaltrials.gov

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