Ignite Creation Date:
2024-05-06 @ 7:06 PM
Last Modification Date:
2024-10-26 @ 3:00 PM
Study NCT ID:
NCT05891873
Status:
RECRUITING
Last Update Posted:
2023-10-23
First Post:
2023-05-17
Brief Title:
Delirium in the NeuroIntensiveCritical Care in the Adult and Paediatric Czech Populations
Sponsor:
Masaryk University
Organization:
Masaryk University
Study Overview
Official Title:
Delirium in the NeuroIntensiveCritical Care in the Adult and Paediatric Czech Populations
Status:
RECRUITING
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Intensive and critical care in the intensive care unit ICU is often associated with ICU delirium and post-ICU dementia regardless of the nature of the primary disease or insult Optimal practical management of ICU delirium including its screening prevention and treatment is an integral part of the current recommendations for optimal ICU care but there are large gaps in the knowledge about the optimal and most effective prevention and treatment of this complication Information on the actual implementation of these recommendations in the Czech Republic is lacking The diagnosis of delirium is particularly challenging in neurointensive care patients due to overlap with symptoms of primary brain lesions and in a paediatric population A complementary multicentre observational 4-year follow-up study performed in an adult neurointensivecritical care stroke cohort and in a paediatric intensivecritical care cohort in centres following currently recommended preventive measures Delusion-deep-cz will investigate the incidence of ICU delirium and post-ICU dementia and their modifiable and non-modifiable predisposing and precipitating risk factors Objectives are to determine the optimal methods for diagnostic screening of these complications and for the differential diagnosis of conditions mimicking delirium non-convulsive epileptic state or symptoms hindering its diagnosis aphasia and to study the association between sleep disturbances and ICU delirium to verify the role of sleep in the pathophysiology of delirium
Detailed Description:
Design
Multicentre observational follow-up cohort study with 2 different cohorts and a minimum follow-up period of 6 months
Recruitment groups
1 Neurointensiveneurocritical 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
2 Paediatric intensivecritical 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 neurointensivecritical 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-intensivecritical 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
Multicentre observational follow-up cohort study with 2 different cohorts and a minimum follow-up period of 6 months
Recruitment groups
1 Neurointensiveneurocritical 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
2 Paediatric intensivecritical 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 neurointensivecritical 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-intensivecritical 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None