Instruments for Delirium Assessment Regarding to Analgesia Sedation and Ventilator Status

Delirium Clinical Trial

— IDEAS  

Official title:

Instruments for Delirium Assessment Regarding to Analgesia Sedation and Ventilator Status

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01720914
• Other study ID #: IDEAS
• Status: Completed
• Phase: N/A
• First received: October 30, 2012
• Last updated: December 22, 2015
• Start date: November 2012
• Est. completion date: December 2015

Study information

• Verified date: December 2015
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Observational

Clinical Trial 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)?

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: December 2015
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Delirium

Locations

Country	Name	City	State
Brazil	Centro de Terapia Intensiva da Hospital Pro-Cardiaco	Botafogo	Rio de Janeiro
Germany	Department of Anesthesiology and Intensive Care Medicine, CVK/CCM, Charité -University Medicine	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany

Countries where clinical trial is conducted

Brazil,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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:	No
Secondary	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	No
Secondary	Administered neuroleptics, cumulative		Participants will be followed in the 7-days sample period	No
Secondary	Administered analgesics, cumulative		Participants will be followed in the 7-days sample period	No
Secondary	Administered sedatives, cumulative		Participants will be followed in the 7-days sample period	No
Secondary	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	No
Secondary	Antibiotics/infections		Participants will be followed in the 7-days sample period	No
Secondary	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	No
Secondary	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	No
Secondary	Discharge mode		Participants will be followed for the duration of intensive care unit stay and hospital stay, an expected average of 4 weeks	No
Secondary	28-day mortality		Participants will be followed for the duration of intensive care unit stay and hospital stay, an expected average of 4 weeks	No
Secondary	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	No
Secondary	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	No