Delirium
Conditions
Brief summary
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)?
Interventions
None listed
Sponsors
Charite University, Berlin, Germany
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sensitivity of the delirium screening/diagnosing tool Confusion Assessment Method for the ICU (CAM-ICU) regarding sedation and ventilator status. | Participants will be followed in the 7-days sample period | Used reference standard: DSM-IV TR criteria |
| Sensitivity of the delirium-screening tool Intensive-Care Delirium Screening Checklist(ICDSC) regarding sedation and ventilator status. | Participants will be followed in the 7-days sample period | Used reference standard: DSM-IV TR criteria. |
| Sensitivity of the delirium screening tool Nursing Delirium Screening Scale (Nu-DESC) regarding sedation and ventilator status. | Participants will be followed in the 7-days sample period | Used reference standard: DSM-IV TR criteria |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Administered sedatives, cumulative | Participants will be followed in the 7-days sample period | — |
| 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. | Participants will be followed in the 7-days sample period | Used reference standard: DSM-IV-TR criteria. |
| Calculation and Analysis of the positive predictive values of the assessed delirium-screening scales. | Participants will be followed in the 7-days sample period | 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 |
| Incidence of delirium | Participants will be followed in the 7-days sample period | According to Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) and Confusion Assessment Method for the ICU (CAM-ICU) |
| Incidence of Subsyndromale Delirium (SSD) | Participants will be followed in the 7-days sample period | According to Intensive Care Delirium Screening Checklist (ICDSC) and Nursing Delirium Screening Scale (Nu-DESC) |
| Analgesia | Participants will be followed in the 7-days sample period: | According to Numeric rating scale visually enlarged and laminated (NRS-V), Behavioural pain scale (BPS) and Behavioural pain scale not intubated (BPS-NI) |
| Severity of illness | Participants will be followed in the 7-days sample period | according to Acute Physiology And Chronic Health score (APACHE 2), Simplified Acute Physiology Score (SAPS 2) and Sequential Organ Failure Assessment score (SOFA) |
| Ventilator status | Participants will be followed in the 7-days sample period | 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. |
| 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. | Participants will be followed in the 7-days sample period | Used reference standard: DSM-IV-TR criteria. |
| 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. | Participants will be followed in the 7-days sample period | Used reference standard: DSM-IV-TR criteria. |
| Antibiotics/infections | 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 | — |
Countries
Brazil, Germany
Outcome results
None listed