- ICH GCP
- USA klinikai vizsgálatok nyilvántartása
- Klinikai vizsgálat NCT01720914
Instruments for Delirium Assessment Regarding to Analgesia Sedation and Ventilator Status (IDEAS)
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)?
A tanulmány áttekintése
Állapot
Körülmények
Tanulmány típusa
Beiratkozás (Tényleges)
Kapcsolatok és helyek
Tanulmányi helyek
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Rio de Janeiro
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Botafogo, Rio de Janeiro, Brazília, RJ 22280-020
- Centro de Terapia Intensiva da Hospital Pro-Cardiaco
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Berlin, Németország, 13353
- Department of Anesthesiology and Intensive Care Medicine, CVK/CCM, Charité -University Medicine
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Részvételi kritériumok
Jogosultsági kritériumok
Tanulmányozható életkorok
Egészséges önkénteseket fogad
Tanulmányozható nemek
Mintavételi módszer
Tanulmányi populáció
Leírás
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
Tanulási terv
Hogyan készül a tanulmány?
Tervezési részletek
Kohorszok és beavatkozások
Csoport / Kohorsz |
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Critically ill patient
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Mit mér a tanulmány?
Elsődleges eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
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Sensitivity of the delirium screening/diagnosing tool "Confusion Assessment Method for the ICU (CAM-ICU)" regarding sedation and ventilator status.
Időkeret: Participants will be followed in the 7-days sample period
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Used reference standard: DSM-IV TR criteria
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Participants will be followed in the 7-days sample period
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Sensitivity of the delirium-screening tool "Intensive-Care Delirium Screening Checklist(ICDSC)" regarding sedation and ventilator status.
Időkeret: Participants will be followed in the 7-days sample period
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Used reference standard: DSM-IV TR criteria.
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Participants will be followed in the 7-days sample period
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Sensitivity of the delirium screening tool "Nursing Delirium Screening Scale (Nu-DESC)" regarding sedation and ventilator status.
Időkeret: Participants will be followed in the 7-days sample period
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Used reference standard: DSM-IV TR criteria
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Participants will be followed in the 7-days sample period
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Másodlagos eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
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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.
Időkeret: Participants will be followed in the 7-days sample period
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Used reference standard: DSM-IV-TR criteria.
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Participants will be followed in the 7-days sample period
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Calculation and Analysis of the positive predictive values of the assessed delirium-screening scales.
Időkeret: Participants will be followed in the 7-days sample period
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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
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Incidence of delirium
Időkeret: Participants will be followed in the 7-days sample period
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According to Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) and Confusion Assessment Method for the ICU (CAM-ICU)
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Participants will be followed in the 7-days sample period
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Incidence of Subsyndromale Delirium (SSD)
Időkeret: Participants will be followed in the 7-days sample period
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According to Intensive Care Delirium Screening Checklist (ICDSC) and Nursing Delirium Screening Scale (Nu-DESC)
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Participants will be followed in the 7-days sample period
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Analgesia
Időkeret: Participants will be followed in the 7-days sample period:
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According to Numeric rating scale visually enlarged and laminated (NRS-V), Behavioural pain scale (BPS) and Behavioural pain scale not intubated (BPS-NI)
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Participants will be followed in the 7-days sample period:
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Ventilator status
Időkeret: Participants will be followed in the 7-days sample period
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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.
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Participants will be followed in the 7-days sample period
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Administered neuroleptics, cumulative
Időkeret: Participants will be followed in the 7-days sample period
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Participants will be followed in the 7-days sample period
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Administered analgesics, cumulative
Időkeret: Participants will be followed in the 7-days sample period
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Participants will be followed in the 7-days sample period
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Administered sedatives, cumulative
Időkeret: Participants will be followed in the 7-days sample period
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Participants will be followed in the 7-days sample period
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Severity of illness
Időkeret: Participants will be followed in the 7-days sample period
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according to Acute Physiology And Chronic Health score (APACHE 2), Simplified Acute Physiology Score (SAPS 2) and Sequential Organ Failure Assessment score (SOFA)
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Participants will be followed in the 7-days sample period
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Antibiotics/infections
Időkeret: Participants will be followed in the 7-days sample period
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Participants will be followed in the 7-days sample period
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ICU length of stay
Időkeret: Participants will be followed for the duration of intensive care unit stay and hospital stay, an expected average of 4 weeks
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Participants will be followed for the duration of intensive care unit stay and hospital stay, an expected average of 4 weeks
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Duration of mechanical ventilation
Időkeret: Participants will be followed for the duration of intensive care unit stay and hospital stay, an expected average of 4 weeks
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Participants will be followed for the duration of intensive care unit stay and hospital stay, an expected average of 4 weeks
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Discharge mode
Időkeret: Participants will be followed for the duration of intensive care unit stay and hospital stay, an expected average of 4 weeks
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Participants will be followed for the duration of intensive care unit stay and hospital stay, an expected average of 4 weeks
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28-day mortality
Időkeret: Participants will be followed for the duration of intensive care unit stay and hospital stay, an expected average of 4 weeks
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Participants will be followed for the duration of intensive care unit stay and hospital stay, an expected average of 4 weeks
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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.
Időkeret: Participants will be followed in the 7-days sample period
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Used reference standard: DSM-IV-TR criteria.
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Participants will be followed in the 7-days sample period
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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.
Időkeret: Participants will be followed in the 7-days sample period
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Used reference standard: DSM-IV-TR criteria.
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Participants will be followed in the 7-days sample period
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Együttműködők és nyomozók
Szponzor
Publikációk és hasznos linkek
Tanulmányi rekorddátumok
Tanulmány főbb dátumok
Tanulmány kezdete
Elsődleges befejezés (Tényleges)
A tanulmány befejezése (Tényleges)
Tanulmányi regisztráció dátumai
Először benyújtva
Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak
Első közzététel (Becslés)
Tanulmányi rekordok frissítései
Utolsó frissítés közzétéve (Becslés)
Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak
Utolsó ellenőrzés
Több információ
A tanulmányhoz kapcsolódó kifejezések
További vonatkozó MeSH feltételek
Egyéb vizsgálati azonosító számok
- IDEAS
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