Diagnosis, Incidence and Consequences of PACU-Delirium

NCT04978870 | Completed

• 1 other identifier: 2020-10331-BO-ff
• Study Type: observational
• Target: 450
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to

1. 1.determine sensitivity and specificity of the Confusion Assessment Method for Postanesthesia Care Unit (CAM-PACU)
2. 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

Conditions

Postoperative Delirium; Elderly Patient; Cognitive Decline

Keywords

Post-anesthetic care; Cognitive recovery; Delirium

Outcome Measures

Primary Outcomes (2)

• Group 1: Sensitivity and specificity of "Confusion Assessment Method - Postanesthetic Care Unit" (CAM-PACU)

  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

  3D CAM and/or medical record

  0-5 days postoperatively

Secondary Outcomes (4)

• re-test reliability

  15-240 minutes postoperatively

• cognitive performance

  before, 7 and 30 days postoperatively

• postoperative complications

  30 days postoperatively

• feasibility of delirium screening by questioning of medical staff

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

Study Arms (2)

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.

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• planned surgery in the near future
• surgery time at least 60min

You may not qualify if:

• 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

Sponsors & Collaborators

• Universitätsklinikum Hamburg-Eppendorf: lead

Study Sites (1)

Hamburg University Medical Centre Eppendorf

Hamburg, Hamburg, 20251, Germany

Location

MeSH Terms

Conditions

Emergence Delirium; Cognitive Dysfunction; Delirium

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Cognition Disorders

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2021
• First Posted: July 27, 2021
• Study Start: July 29, 2021
• Primary Completion: September 30, 2023
• Study Completion: August 1, 2024
• Last Updated: February 21, 2025

Record last verified: 2025-02

Locations

DE (1)