DeliriumNCT03735940
Clinical Evaluation Program of DeltaScan (ICU)
A study of Delirium, run by UMC Utrecht at 1 site in Netherlands.
Trial summary
Rationale: Delirium, or acute brain failure, presents as an acute confusional state, and is associated with prolonged hospitalization, an increased risk of dementia, institutionalization and mortality, as well as increased costs. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Delirium
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 3,630 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Mar 2019to 29 Jun 2021
- Phase
- Interventional
- 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
Who may be able to join
- Admitted to the ICU department
- At risk of delirium, defined according to local protocol:
- ICU patients: when expected stay is > 1 day
Who cannot join
- Age younger than 18 years.
- Admitted because of a primary neurological or neurosurgical disease.
- Patients who cannot clinically assessed for delirium, e.g. due to a language barrier or deafness.
- Known pre-existing dementia.
- We decided to add an extra exclusion criteria: Patients infected with SARS-CoV-19 infection
Trial locations and contacts
1 site in 1 country.
About this study
Official title: DeltaScan for the Assessment of Delirium in the Intensive Care: a Multicenter Stepped Wedge Cluster Randomized Trial (Study 1)
Rationale: Delirium, or acute brain failure, presents as an acute confusional state, and is associated with prolonged hospitalization, an increased risk of dementia, institutionalization and mortality, as well as increased costs. Early detection of delirium would allow for early treatment and improved patient outcomes, but delirium is often not recognized and treatment is therefore delayed or not applied at all. Additionally, current screening tools are subjective, so an alternative, more objective diagnostic tool for early delirium detection is desired. The DeltaScan, a CE-certified device to detect delirium using brief EEG recording, has been recently been found have diagnostic properties that outperform the currently used screening tools.
Objective: To quantify the impact of the use of the DeltaScan on patient outcome (detection rate of delirium and duration of admission) in patients with high risk of delirium compared to the currently used delirium screening tools.
Read more
Study design: A prospective multicenter stepped wedge cluster randomized trials in (at least) 4 ICU departments.
Study population: Adult patients admitted to an intensive care unit (ICU) with high risk of delirium.
Intervention: During 12 months, patients presenting at the ICU of participating hospitals with an expected stay > 1 day will be included in the study. First, all hospitals will apply 'usual care' to all patients, i.e. standard delirium screening (e.g. the Confusion Assessment Method (CAM)-ICU) or other currently used tools) in combination with a delirium treatment protocol and subsequent management without application of the DeltaScan for a period of 3 months. Then, during a 6 month period, each 2 months, starting at day 0, randomly allocated hospitals will sequentially start to apply the DeltaScan in all eligible patients (intervention period). During the last 3 months of the study all hospitals will participate in the intervention period.
Main study endpoints:
Primary endpoints: delirium detection rate (i.e. proportion of positive assessments according to the delirium detection tool), and duration of admission at ICU. Secondary endpoints: time interval between admission and the first delirium positive assessment, number of days with at least one positive delirium assessment, delirium incidence, hospital mortality, and direct medical costs of hospitalization.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: During the intervention period EEG recordings using the CE-certified DeltaScan will be made using a strip with EEG electrodes that will be mounted to the head using self-adhesive gel. The EEG recording will be performed two to three times daily and takes 3-4 minutes. During the usual care period the patients will receive the standard delirium screening tool for delirium assessment by a nurse. This assessment will be performed two to three times daily and takes 2-4 minutes depending on the screening tools that is used. Since the DeltaScan has shown to have superior diagnostic performance compared to the DSM5 the burden/risk of misclassification is lower than with the current standard for delirium assessment. Based on the above we consider the burden to participants in this study to be minimal.
- Conditions
- Delirium
- Being tested
- Spot monitoring device, excl. Sham
- Keywords
- Electroencephalography, Intensive Care, Brain disease, Confusion, Neurobehavioral Manifestations, Nervous System Diseases, Signs and Symptoms, Neurocognitive Disorders, Mental Disorders
- Medical subject headings
- Delirium, Brain Diseases, Confusion, Neurobehavioral Manifestations, Nervous System Diseases, Signs and Symptoms, Neurocognitive Disorders, Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spot monitoring device, excl. ShamOther
- During the control phase the 'care as usual' regarding delirium screening is studied. During the intervention phase the DeltaScan will be studied as screening method for delirium. o During the intervention phase the DeltaScan will be used on the exact same moments, i.e. same time and same amount of measures per day, as the screening methods used in the 'care as usual'.
| Study group | Role | What they receive |
|---|---|---|
| Control phase | No intervention | no intervention, i.e. care as usual |
| Intervention phase | Experimental | experimental intervention: spot monitoring device, i.e. use of DeltaScan Receives: Other: Spot monitoring device, excl. Sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
Delirium detection rate
The detection rate of delirium will be defined as the proportion of delirium positive assessments during conditions that a patient can be assessed for delirium. A positive delirium assessment in the usual care period will be defined as a positive score on the delirium detection tool that is currently used in the participating department according to the protocol of that department. A positive delirium assessment in the intervention period will be defined as a DeltaScan score of 4 or 5.
Measured: From date of admission on the ICU until date of discharge from the ICU or death from any cause, whichever came first, assessed up to 12 months
Length of admission (days)
The duration of admission will be defined as the cumulative duration of ICU admission. The criteria for discharge will be the same in the usual care period and the intervention period.
Measured: From date of admission on the ICU until date of discharge from the ICU or death from any cause, whichever came first, assessed up to 12 months
Secondary outcomes (10)
The time interval between admission (i.e. ICU admission) and the first delirium positive assessment
Measured: From date of admission on the ICU until date of discharge from the ICU or death from any cause, whichever came first, assessed up to 12 months
The number of delirium days
This outcomes is defined as the number of days with at least one positive assessment.
Measured: From date of admission on the ICU until date of discharge from the ICU or death from any cause, whichever came first, assessed up to 12 months
Delirium incidence
Measured: From date of admission on the ICU until date of discharge from the ICU or death from any cause, whichever came first, assessed up to 12 months
Hospital mortality
Measured: From date of admission on the ICU until date of death from any cause, assessed up to 12 months
Direct medical costs of hospitalization
We aim to collect health care consumption in detail for every included patient. This health care consumption for instance consists of number of hospitalization days, medication, diagnostic procedures. These data will be extracted from the hospital systems. General reference prices (open source, National Tariffs) will be applied to this health care consumption to calculate total costs.
Measured: From date of admission on the ICU until date of discharge from the ICU or death from any cause, whichever came first, assessed up to 12 months
Adherence to new delirium treatment protocol
Steps that are taken (e.g. pharmacological or non-pharmacological treatment, consults of specialist etc.) by the hospital staff after a delirium screener gives a delirium positive score.
Measured: From date of admission on the ICU until date of discharge from the ICU or death from any cause, whichever came first, assessed up to 12 months
Duration of mechanical ventilation
Measured: From date of admission on the ICU until date of discharge from the ICU or death from any cause, whichever came first, assessed up to 12 months
Hospital length of stay
Measured: From date of admission on the ICU until date of discharge from the hospital or death from any cause, whichever came first, assessed up to 12 months
Incidence of ICU re-admission
Measured: From date of admission on the ICU until date of discharge from the hospital or death from any cause, whichever came first, assessed up to 12 months
Number of days alive without delirium and without coma (i.e. RASS -3, -4 or -5) in 28 days
Measured: From date of admission on the ICU until date of discharge from the ICU or death from any cause, whichever came first, assessed up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2018
- Study start1 Mar 2019
- Primary completion1 Jun 2021
- Study completion29 Jun 2021
Why it stopped: The pandemic caused a rising tide phenomenon on our primary outcomes 1) Delirium detection (increased by visit reduction \& masked staff) and 2) Admission duration (increased by reorganizations \& quarantines 'impact on being discharged)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for DeliriumStudies of the same condition, open and under way.
- More trials run by UMC UtrechtThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- In this study ICU departments will be randomized with respect to the time they will introduce the DeltaScan following a stepped wedge cluster randomization design. All departments apply 'usual care' in combination with a harmonized delirium treatment protocol during the control phase. After this first time period, each new time period a department switches to the intervention period. Due to the first wave of the COVID-19 pandemic the stepped wedge planning was interrupted. Where possible the control period and/or intervention, whichever was affected, will be extended. We marked the first wave of the COVID-19 pandemic from the 15th of March until the 15th of May or longer for a few heavily effected sites with a maximum of 6 months. Data collected during this period will not be used for primary analysis, but may be used for specific sub analyses.
- Masking
- None (open label)
- Enrolment
- 3,630 participants (actual)
Sponsor and investigators
- Lead sponsor
- UMC Utrecht
- Sponsor type
- University, hospital or other
- Collaborators
- Charite University, Berlin, Germany, KU Leuven, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), Prolira, Factory CRO, Implementation IQ, European Union
- Responsible party
- Principal investigator, A.J.C. Slooter, UMC Utrecht
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03735940
- Sponsor's protocol ID
- FTI-820555-DeltaScan-study1
- Status last verified
- Aug 2022
- First submitted
- 24 Oct 2018
- Last updated
- 19 Aug 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Numan T, van den Boogaard M, Kamper AM, Rood PJT, Peelen LM, Slooter AJC; Dutch Delirium Detection Study Group. Delirium detection using relative delta power based on 1-minute single-channel EEG: a multicentre study. Br J Anaesth. 2019 Jan;122(1):60-68. doi: 10.1016/j.bja.2018.08.021. Epub 2018 Oct 2.
PubMed 30579407van der Kooi AW, Zaal IJ, Klijn FA, Koek HL, Meijer RC, Leijten FS, Slooter AJ. Delirium detection using EEG: what and how to measure. Chest. 2015 Jan;147(1):94-101. doi: 10.1378/chest.13-3050.
PubMed 25166725
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DeltaScan for the Assessment of Delirium in the Intensive Care: a Multicenter Stepped Wedge Cluster Randomized Trial (Study 1)
- ClinicalTrials.gov ID
- NCT03735940
- Acronym / sponsor ID
- FTI-820555-DeltaScan-study1
- Conditions
- Delirium
- Keywords
- Electroencephalography, Intensive Care, Brain disease, Confusion, Neurobehavioral Manifestations, Nervous System Diseases, Signs and Symptoms, Neurocognitive Disorders
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The pandemic caused a rising tide phenomenon on our primary outcomes 1) Delirium detection (increased by visit reduction \& masked staff) and 2) Admission duration (increased by reorganizations \& quarantines 'impact on being discharged)
- Enrolment
- 3,630 participants (actual)
- Lead sponsor
- UMC UtrechtUniversity, hospital or other
- Collaborators
- Charite University, Berlin, Germany, KU Leuven, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), Prolira, Factory CRO, Implementation IQ, European Union
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 1 Jun 2021 (actual)
- Study completion
- 29 Jun 2021 (actual)
- First posted
- 8 Nov 2018 (actual)
- 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.
Rationale: Delirium, or acute brain failure, presents as an acute confusional state, and is associated with prolonged hospitalization, an increased risk of dementia, institutionalization and mortality, as well as increased costs. Early detection of delirium would allow for early treatment and improved patient outcomes, but delirium is often not recognized and treatment is therefore delayed or not applied at all. Additionally, current screening tools are subjective, so an alternative, more objective diagnostic tool for early delirium detection is desired. The DeltaScan, a CE-certified device to detect delirium using brief EEG recording, has been recently been found have diagnostic properties that outperform the currently used screening tools.
Objective: To quantify the impact of the use of the DeltaScan on patient outcome (detection rate of delirium and duration of admission) in patients with high risk of delirium compared to the currently used delirium screening tools.
Study design: A prospective multicenter stepped wedge cluster randomized trials in (at least) 4 ICU departments.
Study population: Adult patients admitted to an intensive care unit (ICU) with high risk of delirium.
Intervention: During 12 months, patients presenting at the ICU of participating hospitals with an expected stay > 1 day will be included in the study. First, all hospitals will apply 'usual care' to all patients, i.e. standard delirium screening (e.g. the Confusion Assessment Method (CAM)-ICU) or other currently used tools) in combination with a delirium treatment protocol and subsequent management without application of the DeltaScan for a period of 3 months. Then, during a 6 month period, each 2 months, starting at day 0, randomly allocated hospitals will sequentially start to apply the DeltaScan in all eligible patients (intervention period). During the last 3 months of the study all hospitals will participate in the intervention period.
Main study endpoints:
Primary endpoints: delirium detection rate (i.e. proportion of positive assessments according to the delirium detection tool), and duration of admission at ICU. Secondary endpoints: time interval between admission and the first delirium positive assessment, number of days with at least one positive delirium assessment, delirium incidence, hospital mortality, and direct medical costs of hospitalization.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: During the intervention period EEG recordings using the CE-certified DeltaScan will be made using a strip with EEG electrodes that will be mounted to the head using self-adhesive gel. The EEG recording will be performed two to three times daily and takes 3-4 minutes. During the usual care period the patients will receive the standard delirium screening tool for delirium assessment by a nurse. This assessment will be performed two to three times daily and takes 2-4 minutes depending on the screening tools that is used. Since the DeltaScan has shown to have superior diagnostic performance compared to the DSM5 the burden/risk of misclassification is lower than with the current standard for delirium assessment. Based on the above we consider the burden to participants in this study to be minimal.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- In this study ICU departments will be randomized with respect to the time they will introduce the DeltaScan following a stepped wedge cluster randomization design. All departments apply 'usual care' in combination with a harmonized delirium treatment protocol during the control phase. After this first time period, each new time period a department switches to the intervention period. Due to the first wave of the COVID-19 pandemic the stepped wedge planning was interrupted. Where possible the control period and/or intervention, whichever was affected, will be extended. We marked the first wave of the COVID-19 pandemic from the 15th of March until the 15th of May or longer for a few heavily effected sites with a maximum of 6 months. Data collected during this period will not be used for primary analysis, but may be used for specific sub analyses.
| Arm | Type | Receives |
|---|---|---|
| Control phase | No intervention | –no intervention, i.e. care as usual |
| Intervention phase | Experimental | Other: Spot monitoring device, excl. Shamexperimental intervention: spot monitoring device, i.e. use of DeltaScan |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Admitted to the ICU department
- At risk of delirium, defined according to local protocol:
- ICU patients: when expected stay is > 1 day
Key exclusion criteria (5 listed)
- Age younger than 18 years.
- Admitted because of a primary neurological or neurosurgical disease.
- Patients who cannot clinically assessed for delirium, e.g. due to a language barrier or deafness.
- Known pre-existing dementia.
- We decided to add an extra exclusion criteria: Patients infected with SARS-CoV-19 infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Spot monitoring device, excl. Shamo During the control phase the 'care as usual' regarding delirium screening is studied. During the intervention phase the DeltaScan will be studied as screening method for delirium. o During the intervention phase the DeltaScan will be used on the exact same moments, i.e. same time and same amount of measures per day, as the screening methods used in the 'care as usual'. | Other | Intervention phase |
Primary outcome
Delirium detection rate
Time frame: From date of admission on the ICU until date of discharge from the ICU or death from any cause, whichever came first, assessed up to 12 months
The detection rate of delirium will be defined as the proportion of delirium positive assessments during conditions that a patient can be assessed for delirium. A positive delirium assessment in the usual care period will be defined as a positive score on the delirium detection tool that is currently used in the participating department according to the protocol of that department. A positive delirium assessment in the intervention period will be defined as a DeltaScan score of 4 or 5.
Length of admission (days)
Time frame: From date of admission on the ICU until date of discharge from the ICU or death from any cause, whichever came first, assessed up to 12 months
The duration of admission will be defined as the cumulative duration of ICU admission. The criteria for discharge will be the same in the usual care period and the intervention period.
10 secondary outcomes
The time interval between admission (i.e. ICU admission) and the first delirium positive assessment
Time frame: From date of admission on the ICU until date of discharge from the ICU or death from any cause, whichever came first, assessed up to 12 months
The number of delirium days
Time frame: From date of admission on the ICU until date of discharge from the ICU or death from any cause, whichever came first, assessed up to 12 months
Delirium incidence
Time frame: From date of admission on the ICU until date of discharge from the ICU or death from any cause, whichever came first, assessed up to 12 months
Hospital mortality
Time frame: From date of admission on the ICU until date of death from any cause, assessed up to 12 months
Direct medical costs of hospitalization
Time frame: From date of admission on the ICU until date of discharge from the ICU or death from any cause, whichever came first, assessed up to 12 months
Adherence to new delirium treatment protocol
Time frame: From date of admission on the ICU until date of discharge from the ICU or death from any cause, whichever came first, assessed up to 12 months
Duration of mechanical ventilation
Time frame: From date of admission on the ICU until date of discharge from the ICU or death from any cause, whichever came first, assessed up to 12 months
Hospital length of stay
Time frame: From date of admission on the ICU until date of discharge from the hospital or death from any cause, whichever came first, assessed up to 12 months
Incidence of ICU re-admission
Time frame: From date of admission on the ICU until date of discharge from the hospital or death from any cause, whichever came first, assessed up to 12 months
Number of days alive without delirium and without coma (i.e. RASS -3, -4 or -5) in 28 days
Time frame: From date of admission on the ICU until date of discharge from the ICU or death from any cause, whichever came first, assessed up to 12 months
Results and safety
The study was stopped early (reason given: The pandemic caused a rising tide phenomenon on our primary outcomes 1) Delirium detection (increased by visit reduction \& masked staff) and 2) Admission duration (increased by reorganizations \& quarantines 'impact on being discharged)). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2022.
- Background: PubMed 30579407Numan T, van den Boogaard M, Kamper AM, Rood PJT, Peelen LM, Slooter AJC; Dutch Delirium Detection Study Group. Delirium detection using relative delta power based on 1-minute single-channel EEG: a multicentre study. Br J Anaesth. 2019 Jan;122(1):60-68. doi: 10.1016/j.bja.2018.08.021. Epub 2018 Oct 2.
- Background: PubMed 25166725van der Kooi AW, Zaal IJ, Klijn FA, Koek HL, Meijer RC, Leijten FS, Slooter AJ. Delirium detection using EEG: what and how to measure. Chest. 2015 Jan;147(1):94-101. doi: 10.1378/chest.13-3050.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Delirium, run by UMC Utrecht at 1 site in Netherlands.
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 3 inclusion and 5 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: stopped early, as of the sponsor's last update on 19 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. 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 was stopped early (reason given: The pandemic caused a rising tide phenomenon on our primary outcomes 1) Delirium detection (increased by visit reduction \& masked staff) and 2) Admission duration (increased by reorganizations \& quarantines 'impact on being discharged)). Results are not available in the source record.
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?
Delirium detection rate (time frame: From date of admission on the ICU until date of discharge from the ICU or death from any cause, whichever came first, assessed up to 12 months). The study lists 2 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 NCT03735940, which also lists 2 linked publications.
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 19 Aug 2022.