Diagnosis, Incidence and Consequences of PACU-Delirium

Cognitive Decline Clinical Trial

— PADE-DIC  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04978870
• Other study ID #: 2020-10331-BO-ff
• Status: Active, not recruiting
• 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
• 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

Related Conditions & MeSH terms

• Cognitive Decline
• Cognitive Dysfunction
• Delirium
• Elderly Patient
• Emergence Delirium
• Postoperative Delirium

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