Clinical trial NCT01720914: Instruments for Delirium Assessment Regarding to Analgesia Sedation and Ventilator Status
Official title: Instruments for Delirium Assessment Regarding to Analgesia Sedation and Ventilator Status
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Delirium
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2012-11-02
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Male and female adult critically ill patients

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)?


Eligibility criteria: 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

Primary outcomes:
measure: Sensitivity of the delirium screening/diagnosing tool "Confusion Assessment Method for the ICU (CAM-ICU)" regarding sedation and ventilator status.
timeFrame: Participants will be followed in the 7-days sample period
measure: Sensitivity of the delirium-screening tool "Intensive-Care Delirium Screening Checklist(ICDSC)" regarding sedation and ventilator status.
timeFrame: Participants will be followed in the 7-days sample period
measure: Sensitivity of the delirium screening tool "Nursing Delirium Screening Scale (Nu-DESC)" regarding sedation and ventilator status.
timeFrame: Participants will be followed in the 7-days sample period
Secondary outcomes:
measure: 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.
timeFrame: Participants will be followed in the 7-days sample period
measure: Calculation and Analysis of the positive predictive values of the assessed delirium-screening scales.
timeFrame: Participants will be followed in the 7-days sample period
measure: Incidence of delirium
timeFrame: Participants will be followed in the 7-days sample period
measure: Incidence of Subsyndromale Delirium (SSD)
timeFrame: Participants will be followed in the 7-days sample period
measure: Analgesia
timeFrame: Participants will be followed in the 7-days sample period:
measure: Ventilator status
timeFrame: Participants will be followed in the 7-days sample period
measure: Administered neuroleptics, cumulative
timeFrame: Participants will be followed in the 7-days sample period
measure: Administered analgesics, cumulative
timeFrame: Participants will be followed in the 7-days sample period
measure: Administered sedatives, cumulative
timeFrame: Participants will be followed in the 7-days sample period
measure: Severity of illness
timeFrame: Participants will be followed in the 7-days sample period
measure: Antibiotics/infections
timeFrame: Participants will be followed in the 7-days sample period
measure: ICU length of stay
timeFrame: Participants will be followed for the duration of intensive care unit stay and hospital stay, an expected average of 4 weeks
measure: Duration of mechanical ventilation
timeFrame: Participants will be followed for the duration of intensive care unit stay and hospital stay, an expected average of 4 weeks
measure: Discharge mode
timeFrame: Participants will be followed for the duration of intensive care unit stay and hospital stay, an expected average of 4 weeks
measure: 28-day mortality
timeFrame: Participants will be followed for the duration of intensive care unit stay and hospital stay, an expected average of 4 weeks
measure: 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.
timeFrame: Participants will be followed in the 7-days sample period
measure: 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.
timeFrame: Participants will be followed in the 7-days sample period
Other outcomes:
Locations:
city: Botafogo
country: Brazil
facility: Centro de Terapia Intensiva da Hospital Pro-Cardiaco
state: Rio de Janeiro
city: Berlin
country: Germany
facility: Department of Anesthesiology and Intensive Care Medicine, CVK/CCM, Charité -University Medicine
Study officials:
References:
citation: 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.