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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:
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)?
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Critically ill patient |
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| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Male and female adult critically ill patients
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centro de Terapia Intensiva da Hospital Pro-Cardiaco | Botafogo | Rio de Janeiro | RJ 22280-020 | Brazil | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32823781 | Derived | Nacul FE, Paul N, Spies CD, Sechting H, Hecht T, Dullinger JS, Piper SK, Luetz A, Balzer FS, Wernecke KD, Sa AK, Barros Ferreira da Costa C, Eymold L, Chenitir C, Weiss B. Influence of Sedation Level and Ventilation Status on the Diagnostic Validity of Delirium Screening Tools in the ICU-An International, Prospective, Bi-Center Observational Study (IDeAS). Medicina (Kaunas). 2020 Aug 13;56(8):411. doi: 10.3390/medicina56080411. |
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| ID | Term |
|---|---|
| D003693 | Delirium |
| ID | Term |
|---|---|
| D003221 | Confusion |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| 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 |
| Department of Anesthesiology and Intensive Care Medicine, CVK/CCM, Charité -University Medicine |
| Berlin |
| State of Berlin |
| 13353 |
| Germany |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |