Instruments for Delirium Assessment Regarding to Analgesia Sedation and Ventilator Status

Study Overview
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Brief Summary
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In this prospective, multicenter observational study we assess the diagnostic validity of the following standard screening instruments for delirium regarding sedation, analgesia and ventilator status in critically ill patients: Confusion Assessment Method for the ICU (CAM-ICU) Intensive Care Delirium Screening Checklist (ICDSC) Nursing-Delirium-Screening-Scale (Nu-DESC) The definite delirium diagnosis (definite in terms of reference standard) is made according to the criteria of the Diagnostic and Statistical Manual of Mental Disorders 4th Edition, text revised (DSM-IV-TR) published by the American Psychiatric Association (APA) which is the Gold Standard to diagnose delirium. Primary research question: Does sedation, ventilator status and analgesia influence the sensitivity of delirium screening tools (DST)?

Official Title
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Instruments for Delirium Assessment Regarding to Analgesia Sedation and Ventilator Status

Conditions
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Delirium

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Critically ill patient Patient age > 18 years Exclusion Criteria: Neurosurgical patients Severe brain injury, intracerebral bleeding, stroke Inability to communicate due to anacusia or severe hearing loss Insufficient language comprehension Patients < 24 h total time of Intensive Care Unit stay Deep sedation (RASS < -3) for ≥ 7 days during study participation

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Critically ill patient<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity of the delirium screening/diagnosing tool Confusion Assessment Method for the ICU (CAM-ICU) regarding sedation and ventilator status. | Used reference standard: DSM-IV TR criteria | Participants will be followed in the 7-days sample period | 
| Sensitivity of the delirium-screening tool Intensive-Care Delirium Screening Checklist(ICDSC) regarding sedation and ventilator status. | Used reference standard: DSM-IV TR criteria. | Participants will be followed in the 7-days sample period | 
| Sensitivity of the delirium screening tool Nursing Delirium Screening Scale (Nu-DESC) regarding sedation and ventilator status. | Used reference standard: DSM-IV TR criteria | Participants will be followed in the 7-days sample period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Specificity of the Confusion Assessment Method for the ICU (CAM-ICU), the Intensive Care Delirium Screening Checklist (ICDSC) and the Nursing Delirium Screening Scale regarding sedation and ventilator status. | Used reference standard: DSM-IV-TR criteria. | Participants will be followed in the 7-days sample period | 
| Calculation and Analysis of the positive predictive values of the assessed delirium-screening scales. | Calculation of positive and negative predictive values of the Confusion Assessment Method for the ICU (CAM-ICU), the Intensive Care Delirium Screening Checklist (ICDSC) and the Nursing Delirium Screening Scale regarding sedation and ventilator status. Used reference standard: DSM-IV-TR criteria | Participants will be followed in the 7-days sample period | 
| Incidence of delirium | According to Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) and Confusion Assessment Method for the ICU (CAM-ICU) | Participants will be followed in the 7-days sample period | 
| Incidence of Subsyndromale Delirium (SSD) | According to Intensive Care Delirium Screening Checklist (ICDSC) and Nursing Delirium Screening Scale (Nu-DESC) | Participants will be followed in the 7-days sample period | 
| Analgesia | According to Numeric rating scale visually enlarged and laminated (NRS-V), Behavioural pain scale (BPS) and Behavioural pain scale not intubated (BPS-NI) | Participants will be followed in the 7-days sample period: | 
| Ventilator status | Clinical observation of A) whether an airway is used B)whether a patient is ventilated with a positive pressure ventilation or a high flow ventilation for more than 6 hours per day. | Participants will be followed in the 7-days sample period | 
| Administered neuroleptics, cumulative |  | Participants will be followed in the 7-days sample period | 
| Administered analgesics, cumulative |  | Participants will be followed in the 7-days sample period | 
| Administered sedatives, cumulative |  | Participants will be followed in the 7-days sample period | 
| Severity of illness | according to Acute Physiology And Chronic Health score (APACHE 2), Simplified Acute Physiology Score (SAPS 2) and Sequential Organ Failure Assessment score (SOFA) | Participants will be followed in the 7-days sample period | 
| Antibiotics/infections |  | Participants will be followed in the 7-days sample period | 
| ICU length of stay |  | Participants will be followed for the duration of intensive care unit stay and hospital stay, an expected average of 4 weeks | 
| Duration of mechanical ventilation |  | Participants will be followed for the duration of intensive care unit stay and hospital stay, an expected average of 4 weeks | 
| Discharge mode |  | Participants will be followed for the duration of intensive care unit stay and hospital stay, an expected average of 4 weeks | 
| 28-day mortality |  | Participants will be followed for the duration of intensive care unit stay and hospital stay, an expected average of 4 weeks | 
| Specificity of the Confusion Assessment Method for the ICU (CAM-ICU), the Intensive Care Delirium Screening Checklist (ICDSC) and the Nursing Delirium Screening Scale regarding analgesia. | Used reference standard: DSM-IV-TR criteria. | Participants will be followed in the 7-days sample period | 
| Sensitivity of the Confusion Assessment Method for the ICU (CAM-ICU), the Intensive Care Delirium Screening Checklist (ICDSC) and the Nursing Delirium Screening Scale regarding analgesia. | Used reference standard: DSM-IV-TR criteria. | Participants will be followed in the 7-days sample period |