NCT01720914

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)?

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
160

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2012

Typical duration for all trials

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 30, 2012

Completed
2 days until next milestone

Study Start

First participant enrolled

November 1, 2012

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 2, 2012

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

December 23, 2015

Status Verified

December 1, 2015

Enrollment Period

1.1 years

First QC Date

October 30, 2012

Last Update Submit

December 22, 2015

Conditions

Delirium

Outcome Measures

Primary Outcomes (3)

  • 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

Secondary Outcomes (17)

  • 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

  • Calculation and Analysis of the positive predictive values of the assessed delirium-screening scales.

    Participants will be followed in the 7-days sample period

  • Incidence of delirium

    Participants will be followed in the 7-days sample period

  • Incidence of Subsyndromale Delirium (SSD)

    Participants will be followed in the 7-days sample period

  • Analgesia

    Participants will be followed in the 7-days sample period:

  • +12 more secondary outcomes

Study Arms (1)

Critically ill patient

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Male and female adult critically ill patients

You may qualify if:

  • Critically ill patient
  • Patient age \> 18 years

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Centro de Terapia Intensiva da Hospital Pro-Cardiaco

Botafogo, Rio de Janeiro, RJ 22280-020, Brazil

Location

Department of Anesthesiology and Intensive Care Medicine, CVK/CCM, Charité -University Medicine

Berlin, State of Berlin, 13353, Germany

Location

Related Publications (1)

  • 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.

    PMID: 32823781DERIVED

MeSH Terms

Conditions

Delirium

Condition Hierarchy (Ancestors)

ConfusionNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurocognitive DisordersMental Disorders

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Department of Anesthesiology and Intensive Care Medicine CVK/CCM, Charite University, Berlin, Germany

Study Record Dates

First Submitted

October 30, 2012

First Posted

November 2, 2012

Study Start

November 1, 2012

Primary Completion

December 1, 2013

Study Completion

December 1, 2015

Last Updated

December 23, 2015

Record last verified: 2015-12

Locations

DE(1)BR(1)