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NCT Number: NCT03934645

Comparison of Delirium Evaluation Tools Effectiveness in Intensive Care Patients

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]).

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Trakya University

Edirne, Centrum, 22030, Turkey (Türkiye)

About this study

Most patients in the intensive care unit (ICU) are entered delirium during hospitalization. Delirium; has been reported that it is associated with significant side effects such as prolonged stay in hospital and intensive care unit, increased morbidity and mortality and high costs. For evaluating delirium in intensive care units; There are several assessment tools such as the Intensive Care Delirium Screening Checklist(ICDSC) etc. The ICDSC checklist is an eight-item screening tool that is based on DSM criteria and applied with data that can be collected through medical records. Its validity has been confirmed by several studies. Assessment tools such as ICDSC; can diagnose after patient is entered the delirium and therefore cannot provide early treatment and preventive measures. Prevention of delirium is more important than the correct treatment of delirium. For preventing delirium; early diagnosis and treatment are necessary. Pre-deliric (DELIRIUM PREDICTION MODEL FOR INTENSIVE CARE PATIENTS) and E-pre-deliric (EARLY PREDICTION MODEL FOR DELIRIUM IN ICU PATIENTS) prediction models; are developed and approved for delirium estimation in intensive care unit patients.

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 by the pre-deliric model. 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.

In this study; the definition of delirium was done by ICDSC scoring. Patients with an ICDSC score of 4 and over were diagnosed with delirium.

The aim of this study; To determine the sensitivity and specificity of E-pre-deliric and Pre-deliric scores by comparing the effectiveness of ICDSC, E-pre-deliric, Pre-deliric version-1 and Pre-deliric version-2 assessment tools in the prediction of delirium.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

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.

Other names: Pre-deliric version-1

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.

Other names: Pre-deliric version-2

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.

Other names: E-pre-deliric

Primary outcomes

  1. Rate of Predeliric version-1 model

    Time frame: 1 day in admission (1 time)

    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.

  2. Rate of Predeliric version-2 model

    Time frame: 1 day in admission (1 time)

    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.

  3. Rate of E-predeliric model

    Time frame: 1 day in admission (1 time)

    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.

Secondary outcomes

  1. ICDSC score

    Time frame: 1 time per day during hospitalization

    The items include the assessment of: (1) consciousness ( deep sedation/coma, agitation, normal wakefulness, or light sedation); (2) inattention; (3) disorientation; (4) hallucination, delusion, or psychosis; (5) psychomotor agitation or retardation; (6) inappropriate speech or mood; (7) sleep-wake cycle disturbances; and (8) fluctuation of symptomatology. The maximum score is eight; scores of ≥4 indicate the presence of delirium and score zero is indicate not in delirium. Each item is scored 0-8.

Sponsors and collaborators

Lead sponsor

Trakya University

Other

Registry information

Official study title

Comparison of Efficacy of "Pre-deliric Version 1-2, E-predeliric Score and ICDSC" Tests Used in the Diagnosis of Delirium in Intensive Care Patients

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
May 2, 2019
Registry last updated
Mar 11, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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