DeliriumIDEASNCT01720914
Instruments for Delirium Assessment Regarding to Analgesia Sedation and Ventilator Status
An observational study of Delirium, run by Charite University, Berlin, Germany at 2 sites in 2 countries.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Delirium
- How many people
- 160 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Nov 2012to Dec 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Male and female adult critically ill patients
Who may be able to join
- Critically ill patient
- Patient age > 18 years
Who cannot join
- 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
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Brazil1 site
Centro de Terapia Intensiva da Hospital Pro-Cardiaco
Botafogo, Rio de Janeiro, RJ 22280-020
Germany1 site
Department of Anesthesiology and Intensive Care Medicine, CVK/CCM, Charité -University Medicine
Berlin, State of Berlin, 13353
About this study
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)
Read more
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)?
- Conditions
- Delirium
- Medical subject headings
- Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Critically ill patient | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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
Measured: 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.
Used reference standard: DSM-IV-TR criteria.
Measured: Participants will be followed in the 7-days sample period
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
Measured: Participants will be followed in the 7-days sample period
Incidence of delirium
According to Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) and Confusion Assessment Method for the ICU (CAM-ICU)
Measured: Participants will be followed in the 7-days sample period
Incidence of Subsyndromale Delirium (SSD)
According to Intensive Care Delirium Screening Checklist (ICDSC) and Nursing Delirium Screening Scale (Nu-DESC)
Measured: Participants will be followed in the 7-days sample period
Analgesia
According to Numeric rating scale visually enlarged and laminated (NRS-V), Behavioural pain scale (BPS) and Behavioural pain scale not intubated (BPS-NI)
Measured: Participants will be followed in the 7-days sample period:
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.
Measured: Participants will be followed in the 7-days sample period
Administered neuroleptics, cumulative
Measured: Participants will be followed in the 7-days sample period
Administered analgesics, cumulative
Measured: Participants will be followed in the 7-days sample period
Administered sedatives, cumulative
Measured: Participants will be followed in the 7-days sample period
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)
Measured: Participants will be followed in the 7-days sample period
Antibiotics/infections
Measured: Participants will be followed in the 7-days sample period
ICU length of stay
Measured: Participants will be followed for the duration of intensive care unit stay and hospital stay, an expected average of 4 weeks
Duration of mechanical ventilation
Measured: Participants will be followed for the duration of intensive care unit stay and hospital stay, an expected average of 4 weeks
Discharge mode
Measured: Participants will be followed for the duration of intensive care unit stay and hospital stay, an expected average of 4 weeks
28-day mortality
Measured: Participants will be followed for the duration of intensive care unit stay and hospital stay, an expected average of 4 weeks
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.
Measured: Participants will be followed in the 7-days sample period
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.
Measured: Participants will be followed in the 7-days sample period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2012 (estimated)
- Study startNov 2012
- Primary completionDec 2013
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DeliriumStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Claudia Spies, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01720914
- Sponsor's protocol ID
- IDEAS
- Acronym
- IDEAS
- Status last verified
- Dec 2015
- First submitted
- 30 Oct 2012
- Last updated
- 23 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 32823781
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Instruments for Delirium Assessment Regarding to Analgesia Sedation and Ventilator Status
- ClinicalTrials.gov ID
- NCT01720914
- Acronym / sponsor ID
- IDEAS / IDEAS
- Conditions
- Delirium
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- Nov 2012
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 2 Nov 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)?
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Critically ill patient | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Male and female adult critically ill patients
Key inclusion criteria (2 listed)
- Critically ill patient
- Patient age > 18 years
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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.
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
17 secondary outcomes
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
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
Incidence of delirium
Time frame: Participants will be followed in the 7-days sample period
Incidence of Subsyndromale Delirium (SSD)
Time frame: Participants will be followed in the 7-days sample period
Analgesia
Time frame: Participants will be followed in the 7-days sample period:
Ventilator status
Time frame: Participants will be followed in the 7-days sample period
Administered neuroleptics, cumulative
Time frame: Participants will be followed in the 7-days sample period
Administered analgesics, cumulative
Time frame: Participants will be followed in the 7-days sample period
Administered sedatives, cumulative
Time frame: Participants will be followed in the 7-days sample period
Severity of illness
Time frame: Participants will be followed in the 7-days sample period
Antibiotics/infections
Time frame: Participants will be followed in the 7-days sample period
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
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
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2015.
- Derived from this study: PubMed 32823781Nacul 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Delirium, run by Charite University, Berlin, Germany at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Brazil, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01720914, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2015; AzTrials last refreshed its copy on 7 Nov 2026.