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Completed

NCT Number: NCT01720914

Instruments for Delirium Assessment Regarding to Analgesia Sedation and Ventilator Status

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)?

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Key information

Conditions

Delirium Confusion Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Centro de Terapia Intensiva da Hospital Pro-Cardiaco, Botafogo, Rio de Janeiro, Brazil

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Sensitivity of the delirium screening/diagnosing tool "Confusion Assessment Method for the ICU (CAM-ICU)" regarding sedation and ventilator status.

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

    Used reference standard: DSM-IV TR criteria

  2. Sensitivity of the delirium-screening tool "Intensive-Care Delirium Screening Checklist(ICDSC)" regarding sedation and ventilator status.

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

    Used reference standard: DSM-IV TR criteria.

  3. Sensitivity of the delirium screening tool "Nursing Delirium Screening Scale (Nu-DESC)" regarding sedation and ventilator status.

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

    Used reference standard: DSM-IV TR criteria

Secondary outcomes

  1. 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.

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

    Used reference standard: DSM-IV-TR criteria.

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

    Time frame: 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 criteria

  3. Incidence of delirium

    Time frame: 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)

  4. Incidence of Subsyndromale Delirium (SSD)

    Time frame: 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)

  5. Analgesia

    Time frame: 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)

  6. Ventilator status

    Time frame: 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.

  7. Administered neuroleptics, cumulative

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

  8. Administered analgesics, cumulative

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

  9. Administered sedatives, cumulative

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

  10. Severity of illness

    Time frame: 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)

  11. Antibiotics/infections

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

  12. ICU length of stay

    Time frame: Participants will be followed for the duration of intensive care unit stay and hospital stay, an expected average of 4 weeks

  13. Duration of mechanical ventilation

    Time frame: Participants will be followed for the duration of intensive care unit stay and hospital stay, an expected average of 4 weeks

  14. Discharge mode

    Time frame: Participants will be followed for the duration of intensive care unit stay and hospital stay, an expected average of 4 weeks

  15. 28-day mortality

    Time frame: Participants will be followed for the duration of intensive care unit stay and hospital stay, an expected average of 4 weeks

  16. 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.

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

    Used reference standard: DSM-IV-TR criteria.

  17. 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.

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

    Used reference standard: DSM-IV-TR criteria.

Sponsors and collaborators

Lead sponsor

Charite University, Berlin, Germany

Other

Registry information

Acronym: IDEAS

Important dates

Study start
2012
Primary completion
2013
Study completion
2015
First posted
Nov 2, 2012
Registry last updated
Dec 23, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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