Condition or disease | Intervention/treatment |
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Delirium | 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 |
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.
Study Type : | Observational |
Actual Enrollment : | 250 participants |
Observational Model: | Other |
Time Perspective: | Prospective |
Official 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 |
Actual Study Start Date : | November 1, 2017 |
Actual Primary Completion Date : | June 30, 2019 |
Actual Study Completion Date : | November 1, 2019 |
Group/Cohort | Intervention/treatment |
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Not In Delirium
Intensive Care Delirium Screening Checklist(ICDSC)=0
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Other: Delirium prediction model for ICU patients, version 1
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 Name: Pre-deliric version-1
Other: Delirium prediction model for ICU patients, version 2 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 Name: Pre-deliric version-2
Other: Early prediction model for delirium in ICU patients 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 Name: E-pre-deliric
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In Delirium
Intensive Care Delirium Screening Checklist(ICDSC)≥4
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Other: Delirium prediction model for ICU patients, version 1
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 Name: Pre-deliric version-1
Other: Delirium prediction model for ICU patients, version 2 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 Name: Pre-deliric version-2
Other: Early prediction model for delirium in ICU patients 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 Name: E-pre-deliric
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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
Exclusion Criteria:
Turkey | |
Trakya University | |
Edirne, Centrum, Turkey, 22030 |
Principal Investigator: | DİLEK MEMİŞ, Proffesor | Trakya University |
Tracking Information | |||||
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First Submitted Date | April 19, 2019 | ||||
First Posted Date | May 2, 2019 | ||||
Last Update Posted Date | March 11, 2020 | ||||
Actual Study Start Date | November 1, 2017 | ||||
Actual Primary Completion Date | June 30, 2019 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures |
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Original Primary Outcome Measures | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures |
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.
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Original Secondary Outcome Measures | Same as current | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title | Comparison of Delirium Evaluation Tools Effectiveness in Intensive Care Patients | ||||
Official 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 | ||||
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]). | ||||
Detailed Description |
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. |
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Study Type | Observational | ||||
Study Design | Observational Model: Other Time Perspective: Prospective |
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Target Follow-Up Duration | Not Provided | ||||
Biospecimen | Not Provided | ||||
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. | ||||
Condition | Delirium | ||||
Intervention |
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Study Groups/Cohorts |
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status | Completed | ||||
Actual Enrollment |
250 | ||||
Original Estimated Enrollment | Same as current | ||||
Actual Study Completion Date | November 1, 2019 | ||||
Actual Primary Completion Date | June 30, 2019 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers | No | ||||
Contacts | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries | Turkey | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number | NCT03934645 | ||||
Other Study ID Numbers | TÜTF-BAEK 2017/263 | ||||
Has Data Monitoring Committee | Yes | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement |
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Responsible Party | Onur Kucuk, Trakya University | ||||
Study Sponsor | Trakya University | ||||
Collaborators | Not Provided | ||||
Investigators |
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PRS Account | Trakya University | ||||
Verification Date | March 2020 |