Ignite Creation Date:
2025-12-24 @ 3:00 PM
Ignite Modification Date:
2026-02-24 @ 2:06 PM
Study NCT ID:
NCT03813459
Status:
COMPLETED
Last Update Posted:
2021-12-14
First Post:
2019-01-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Subsyndromal Delirium in Intensive Care Unit
Sponsor:
Centro Hospitalar Lisboa Ocidental
Organization:
Study Overview
Official Title:
Subsyndromal Delirium in Intensive Care Unit, a Multicenter Study
Status:
COMPLETED
Status Verified Date:
2021-12
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:
SubSynD
Brief Summary:
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.
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:
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)).
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)).
Study Oversight
Has Oversight DMC:
False
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?: