Comparison of Delirium Evaluation Tools Effectiveness in Intensive Care Patients

NCT03934645 | Completed DMC

• 1 other identifier: TÜTF-BAEK 2017/263
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

This study compares the efficacy of scoring models used in delirium prediction in patients applying to intensive care unit. The diagnosis of delirium is based on the Intensive Care Delirium Screening Checklist (ICDSC). The aim of this study is determine the sensitivity and specificity of three prediction models (Delirium prediction model for ICU patients version 1 \[Predeliric version-1\], Delirium prediction model for ICU patients version 2 \[Predeliric version-2\] and Early prediction model for delirium in ICU patients \[E-Predeliric\]).

Conditions

Delirium

Keywords

delirium; Intensive Care Delirium Screening Checklist (ICDSC); intensive care unit (ICU); Delirium prediction model for ICU patients version 1; Delirium prediction model for ICU patients version 2; Early prediction model for delirium in ICU patients; sensitivity; specificity

Outcome Measures

Primary Outcomes (3)

• Rate of Predeliric version-1 model

  Data of the patient (ten risk factors) in the first 24 hours of admission to the intensive care unit are collected and the delirium prediction score is calculated. Each item is scored 0-100.

  1 day in admission (1 time)

• Rate of Predeliric version-2 model

  Data of the patient (ten risk factors) in the first 24 hours of admission to the intensive care unit are collected and the delirium prediction score is calculated. Each item is scored 0-100.

  1 day in admission (1 time)

• Rate of E-predeliric model

  In the e-pre-deliric model, delirium prediction score is calculated by inputting the data of the patient (nine predictors) in admission to the intensive care unit. Each item is scored 0-100.

  1 day in admission (1 time)

Secondary Outcomes (1)

• ICDSC score

  1 time per day during hospitalization

Study Arms (2)

Not In Delirium

Intensive Care Delirium Screening Checklist(ICDSC)=0

Other: Delirium prediction model for ICU patients, version 1; Other: Delirium prediction model for ICU patients, version 2; Other: Early prediction model for delirium in ICU patients

In Delirium

Intensive Care Delirium Screening Checklist(ICDSC)≥4

Other: Delirium prediction model for ICU patients, version 1; Other: Delirium prediction model for ICU patients, version 2; Other: Early prediction model for delirium in ICU patients

Interventions

Delirium prediction model for ICU patients, version 1 OTHER

The pre-deliric model version 1 for intensive care patients consists of ten risk factors that are readily available within 24 hours after intensive care admission and has a high predictive value. The model allows for early prediction of delirium and initiation of preventive measures. Data of the patient in the first 24 hours of admission to the intensive care unit are collected and the delirium prediction score is found.

Also known as: Pre-deliric version-1

In Delirium; Not In Delirium

Delirium prediction model for ICU patients, version 2 OTHER

The pre-deliric model version 2 for intensive care patients consists of ten risk factors that are readily available within 24 hours after intensive care admission. Data of the patient in the first 24 hours of admission to the intensive care unit are collected and the delirium prediction score is found. The model allows for early prediction of delirium and initiation of preventive measures.

Also known as: Pre-deliric version-2

In Delirium; Not In Delirium

Early prediction model for delirium in ICU patients OTHER

The e-pre-deliric model enables the clinician to identify those patients likely to develop delirium following ICU admission using only nine predictors. In the e-pre-deliric model, delirium prediction score is determined by inputting the data of the patient in admission to the intensive care unit.

Also known as: E-pre-deliric

In Delirium; Not In Delirium

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

In our study, 250 patients hospitalized more than twenty-four hours in the anesthesia intensive care unit of Trakya University Medical Faculty between 01 November 2017 and 01 November 2019 were accepted.

You may qualify if:

• Patients hospitalized in the intensive care unit for more than 24 hours
• Patients 18 years and older
• Patients without mental disability
• Non-pregnant patients

You may not qualify if:

• Patients hospitalized in the intensive care unit for less than 24 hours
• Patients under 18 years
• Patients in coma during hospitalization in the intensive care unit
• Patients with aphasia disease, who cannot communicate
• If the compliance rate of the delirium screening was \<%80 during a patient's stay in the ICU
• If signs of delirium are seen within 24 hours of ICU admission

Sponsors & Collaborators

• Trakya University: lead

Study Sites (1)

Trakya University

Edirne, Centrum, 22030, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Delirium; Hypersensitivity

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Immune System Diseases

Study Officials

• DİLEK MEMİŞ, Proffesor

  Trakya University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department of anesthesiology and reanimation Resident Doctor

Study Record Dates

• First Submitted: April 19, 2019
• First Posted: May 2, 2019
• Study Start: November 1, 2017
• Primary Completion: June 30, 2019
• Study Completion: November 1, 2019
• Last Updated: March 11, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)