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Completed

NCT Number: NCT04978870

Diagnosis, Incidence and Consequences of PACU-Delirium

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

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Key information

Conditions

Postoperative Delirium Cognition Disorders Cognitive Decline Cognitive Dysfunction Confusion Delirium Elderly Patient Emergence Delirium Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

65 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hamburg University Medical Centre Eppendorf

Hamburg, Free and Hanseatic City of Hamburg, 20251, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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)

  2. Group 2: postoperative delirium after discharge from Postanesthetic Care Unit

    Time frame: 0-5 days postoperatively

    3D CAM and/or medical record

Secondary outcomes

  1. re-test reliability

    Time frame: 15-240 minutes postoperatively

    CAM-PACU

  2. 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)

  3. 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

  4. feasibility of delirium screening by questioning of medical staff

    Time frame: before, 3 and 12 months after implementation of CAM-PACU

    self-designed questionnaire

Sponsors and collaborators

Lead sponsor

Universitätsklinikum Hamburg-Eppendorf

Other

Registry information

Official study title

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

Acronym: PADE-DIC

Important dates

Study start
2021
Primary completion
2023
Study completion
2024
First posted
Jul 27, 2021
Registry last updated
Feb 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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