Subsyndromal Delirium in Intensive Care Unit

Study Overview
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Brief Summary
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Subsyndromal delirium (SSD) is a condition characterized by a less severe cognitive impairment in comparison to delirium. To date there is no published consensus on SSD definitions and has been commonly reported as an intermediate stage between delirium and normal mental states. SSD encompasses some of the delirium symptoms, and has been diagnosed with Intensive Care Delirium Screening Checklist scale (ICDSC) and Confusion Assessment Method-ICU (CAM-ICU). The objective of this study is to identify subsyndromal delirium prevalence, the association between SSD and clinical outcomes and understanding the relationship between SSD and conversion to delirium. The relevance of this study is understanding of subsyndromal delirium in ICU, namely the importance of early presentations of acute brain dysfunction in the patients outcome.

Detailed Description
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SubSynD is a prospective, observational, multicenter clinical study, involving 400 patients in Intensive Care Units, to assess subsyndromal delirium. A systematic screening for delirium and subsyndromal delirium (SSD) is done with Intensive Care Delirium Screening Checklist (ICDSC) and Confusion Assessment Method-ICU (CAM-ICU). Scales are applied once per day until ICU discharge or for up to 14 days of being in ICU. The investigators access three different groups of patients: non-delirium, delirium and subsyndromal delirium. It is intended that either ICDSC or CAM-ICU, paired with a Richmond Agitation and Sedation Scale (RASS) be administered once per day (i.e. with first assessment in the morning). All patients with abnormal CAM-ICU or ICDSC features, beside the underlying cause of delirium and SSD are included. In addition, data regarding baseline demographic and clinical characteristics will be collected as well as data regarding the procedure performed (see Case Report Form (CRF)).

Official Title
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Subsyndromal Delirium in Intensive Care Unit, a Multicenter Study

Conditions
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Delirium

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 years; Admission in Intensive care Unit Exclusion Criteria: Primary neurological diagnosis, with Glasgow Coma Scale (GCS) <14 on ICU admission or in previous days; Blindness or deafness; Aphasia; Inability to communicate in the native language of the country where the study is enrolled; Death during the first 24 hours; Limitation of therapeutic efforts in the Intensive Care Unit admission; Refusal to participate; Previous diagnosis of dementia or psychiatric illness; Readmission in ICU;

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Subsyndromal delirium positive<br>Presence of Subsyndromal delirium in Intensive Care patients | |
| Delirium positive<br>Presence of Delirium in Intensive Care patients | |
| No delirium<br>Non subsyndromal delirium or delirium in Intensive Care patients | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with conversion from subsyndromal delirium to delirium during the period of study | ICDSC performed 1 time per day and determine how subsyndromal delirium (ICDSC 1-3) can have conversion to delirium (ICDSC >/=4). | 14 days | 
| Mortality | defined as number of days that patients survived in 28 days | 28 days | 
| Ventilation free days | defined has the number of days from day 1 to day 28 on which a patient breathed without assistance | 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ICU length of stay | days until ICU discharge | 24 months | 
| Hospital length of stay | days until ICU discharge | 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Delirium, Subsyndromal delirium, Intensive Care Unit