Clinical trial NCT05891873: Delirium in the (Neuro)Intensive/Critical Care in the Adult and Paediatric Czech Populations
Official title: Delirium in the (Neuro)Intensive/Critical Care in the Adult and Paediatric Czech Populations
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Delirium
Keywords: delirium
delirium screening
ICU delirium
Lead sponsor: Masaryk University
Sponsor class: OTHER
Collaborators: name: Brno University Hospital
name: University Hospital, Motol
First posted: 2023-06-07
Enrollment: 700
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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).

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 neurointensive/critical care stroke cohort and in a paediatric intensive/critical 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. 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).
2. 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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of participants who develop ICU delirium
timeFrame: up to 14 days after admission
Secondary outcomes:
measure: Length of stay in ICU
timeFrame: up to 10 weeks
measure: Mortality
timeFrame: 6 months
measure: Number of participants and severity of post-ICU dementia, cognitive impairment(Blessed dementia scale, BDS)
timeFrame: 6 months
measure: Degree of functional dependency (Barthel index)
timeFrame: up to 10 weeks and after 6 months
Other outcomes:
Locations:
city: Brno
country: Czechia
facility: Brno University Hospital
Study officials:
References: