Instruments for Delirium Assessment Regarding to Analgesia Sedation and Ventilator Status
- Conditions
- Delirium
- Registration Number
- NCT01720914
- Lead Sponsor
- Charite University, Berlin, Germany
- 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)?
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 160
- Critically ill patient
- Patient age > 18 years
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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 criteriaIncidence 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)
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.
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 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)
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. 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.
Trial Locations
- Locations (2)
Centro de Terapia Intensiva da Hospital Pro-Cardiaco
🇧🇷Botafogo, Rio de Janeiro, Brazil
Department of Anesthesiology and Intensive Care Medicine, CVK/CCM, Charité -University Medicine
🇩🇪Berlin, Germany