- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05891873
Delirium in the (Neuro)Intensive/Critical Care in the Adult and Paediatric Czech Populations
Study Overview
Status
Conditions
Detailed Description
Design
• Multicentre observational follow-up cohort study with 2 different cohorts and a minimum follow-up period of 6 months.
Recruitment (groups)
- Neurointensive/neurocritical group (N-ICU): patients with acute ischaemic or haemorrhagic stroke admitted to the Stroke Unit or ICU of the Department of Neurology, University Hospital Brno (NK-UHB).
- Paediatric intensive/critical group (P-ICU): children aged 6-18 years, admitted to the Paediatric ICU - Department of Paediatric Anaesthesiology and Intensive Care (KDAR-UHB) with a stay of at least 24 hours (including postoperative care).
General working hypotheses
- Current recommendations for the practical management (PADIS) and prevention of delirium lead to a decrease in the incidence of ICU-delirium and post-ICU dementia and may also change the spectrum of significant risk factors.
- In the Czech Republic, both general knowledge and practical implementation of these recommendations may be low.
- Currently recommended screening instruments for ICU-delirium are valid and reliable in both adult and paediatric cohorts of (neuro)intensive/critical patients and can replace the expert assessment using DSM-IV or V criteria (The Diagnostic and Statistical Manual of Mental Illnesses).
- Non-convulsive status epilepticus (NCSE) may mimic ICU-delirium and a routine EEG exam in patients meeting the criteria for ICU delirium may be helpful.
- Aphasia may complicate the diagnosis of delirium and may prevent the use of the current screening tools for delirium in neurointensive care patients.
- Sleep disturbances in ICU patients are often associated with the development of ICU delirium and evaluating the time course of these conditions may reveal their possible causal relationship.
Outcomes Primary outcomes
- Development of ICU delirium Secondary outcomes
- Length of stay in ICU
- Case-fatality risk
- Post-ICU dementia (BDS, Blessed dementia scale)
- Degree of functional dependency (Barthel index)
Objectives
- To review the incidence and significant modifiable and non-modifiable predisposing and precipitating risk factors for ICU delirium and post-ICU dementia in general and neuro-intensive/critical care in adult and paediatric populations treated in health care facilities according to current recommendations for prevention of these complications (ABCDEF bundle).
- To verify optimal methods for diagnostic screening of ICU delirium: CAM-ICU (The confusion assessment method for the ICU), 4AT (Rapid clinical test for delirium detection - 4AT) and ICDSC (Intensive care delirium screening checklist) in adult populations and pCAM-ICU (paediatric confusion assessment method for the ICU), psCAM-ICU (pre-school confusion assessment method for the ICU) and CAPD (Cornell Assessment of Pediatric Delirium) in paediatric populations to screen for delirium.
- To verify optimal methods for the differential diagnosis of conditions that mimic or complicate the diagnosis of ICU delirium: NCSE, aphasia,
- To investigate associations between sleep disturbances and ICU-delirium to confirm their role in the pathophysiology of delirium.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Josef Bednařík, prof. MD, CSc.
- Phone Number: 532231481
- Email: bednarik.josef@fnbrno.cz
Study Contact Backup
- Name: Lucia Bakošová, MD
- Phone Number: 532232503
- Email: bakosova.lucia@fnbrno.cz
Study Locations
-
-
-
Brno, Czechia, 62500
- Recruiting
- Brno University Hospital
-
Contact:
- Josef Bednařík, prof. MD, CSc.
- Phone Number: 532231481
- Email: bednarik.josef@fnbrno.cz
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Neurointensive/neurocritical group (N-ICU): patients with acute ischaemic or haemorrhagic stroke admitted to the Stroke Unit or ICU of the Department of Neurology, University Hospital Brno (NK-UHB).
Paediatric intensive/critical group (P-ICU): children aged 6-18 years, admitted to the Paediatric ICU - Department of Paediatric Anaesthesiology and Intensive Care (KDAR-UHB) with a stay of at least 24 hours (including postoperative care).
Description
Inclusion Criteria:
- Neurointensive/neurocritical group (N-ICU): patients with acute ischaemic or haemorrhagic stroke admitted to the Stroke Unit or ICU of the Department of Neurology, University Hospital Brno (NK-UHB).
- Paediatric intensive/critical group (P-ICU): children aged 6-18 years, admitted to the Paediatric ICU - Department of Paediatric Anaesthesiology and Intensive Care (KDAR-UHB) with a stay of at least 24 hours (including postoperative care).
Exclusion Criteria:
- (N-ICU) severe trauma with short life expectancy (days)
- duration of the ICU stay shorter than 24 hours
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Neurointensive/neurocritical group (N-ICU)
|
Patients who meet the inclusion criteria will be screened daily for delirium using the screening test mentioned above.
Patients who meet the inclusion criteria will be screened daily for delirium using the screening test mentioned above.
Patients who meet the inclusion criteria will be screened daily for delirium using the screening test mentioned above.
People with aphasia will be examined by a skilled speech therapist.
Patients with positive delirium will undergo EEG examination.
10-min native EEG.
|
Paediatric intensive/critical group (P-ICU)
|
Patients with positive delirium will undergo EEG examination.
10-min native EEG.
Patients who meet the inclusion criteria will be screened daily for delirium using the screening test mentioned above.
Patients who meet the inclusion criteria will be screened daily for delirium using the screening test mentioned above.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of participants who develop ICU delirium
Time Frame: up to 14 days after admission
|
assessed by experienced neuro-intensivist
|
up to 14 days after admission
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mortality
Time Frame: 6 months
|
6 months
|
|
Length of stay in ICU
Time Frame: up to 10 weeks
|
up to 10 weeks
|
|
Number of participants and severity of post-ICU dementia, cognitive impairment(Blessed dementia scale, BDS)
Time Frame: 6 months
|
6 months
|
|
Degree of functional dependency (Barthel index)
Time Frame: up to 10 weeks and after 6 months
|
the higher score, the worse result meaning cognitive impairment and non-independence
|
up to 10 weeks and after 6 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- DELUSION-DEEP-CZ
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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