Viewing Study NCT06279390



Ignite Creation Date: 2024-05-06 @ 8:09 PM
Last Modification Date: 2024-10-26 @ 3:22 PM
Study NCT ID: NCT06279390
Status: COMPLETED
Last Update Posted: 2024-02-28
First Post: 2023-11-12

Brief Title: PRE-DELIRIC Prediction Model Plus SMART Care to Reduce the Incidence of Delirium in ICU Patients
Sponsor: National Taiwan University Hospital
Organization: National Taiwan University Hospital

Study Overview

Official Title: Effectiveness of PRE-DELIRIC-Guided SMARTSmART Care in Reducing Delirium Incidence Among Surgical Intensive Care Unit Patients
Status: COMPLETED
Status Verified Date: 2023-06
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: Delirium is a severe acute brain dysfunction characterised by sudden confusion inattention and fluctuating level of consciousness which mainly affects intubated intensive care patients It increases the risk of self-extubation prolongs ICU stay and increases mortality The incidence of delirium in ICUs varies with approximately 333 of patients affected and rates of new-onset and pre-existing delirium range from 4 to 89 Accurate diagnosis is challenging with 60-80 of patients remaining undiagnosed Early detection is critical for intervention and improved outcomes

To address these issues the PREdiction of DELIRium PRE-DELIRIC model incorporates 10 risk factors and predicts delirium within 24 hours of ICU admission allowing risk stratification into low to very high risk categories It recalibrates predictive values with a sensitivity of 913 and specificity of 644 using a cut-off score of 27 However its integration into delirium management is underexplored Delirium risk stratification supports efficient resource allocation cost control workload reduction and ethical care while promptly identifying high-risk patients

In this study Investigators evaluate the integration of the PRE-DELIRIC model into a comprehensive delirium management approach called PRE-DELIRIC-guided SMARTSmART care SMART care includes improving familiarity assessing pain and anxiety reducing equipment discomfort and cognitive stimulation Patients with PRE-DELIRIC scores 30 receive SMART care and multidisciplinary involvement based on the American Delirium Society
Detailed Description: None

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None