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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04978870
Other study ID # 2020-10331-BO-ff
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date July 29, 2021
Est. completion date September 2024

Study information

Verified date December 2023
Source Universitätsklinikum Hamburg-Eppendorf
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 450
Est. completion date September 2024
Est. primary completion date September 30, 2023
Accepts healthy volunteers No
Gender All
Age group 65 Years and older
Eligibility 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 Design


Locations

Country Name City State
Germany Hamburg University Medical Centre Eppendorf Hamburg

Sponsors (1)

Lead Sponsor Collaborator
Universitätsklinikum Hamburg-Eppendorf

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary Group 2: postoperative delirium after discharge from Postanesthetic Care Unit 3D CAM and/or medical record 0-5 days postoperatively
Secondary re-test reliability CAM-PACU 15-240 minutes postoperatively
Secondary cognitive performance 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
Secondary postoperative complications 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
Secondary feasibility of delirium screening by questioning of medical staff self-designed questionnaire before, 3 and 12 months after implementation of CAM-PACU
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