To quantify the impact of the use of DeltaScan on patient outcome (duration of admission) in patients with high risk of delirium compared to the currently used delirium screening tools.
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
cognitieve aandoeningen
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary endpoints: duration of admission at trauma geriatric department (length
of stay)
Secondary outcome
Secondary endpoints: time interval between admission and the first delirium
positive assessment, number of days with at least one positive delirium
assessment, delirium incidence, hospital mortality, and direct medical costs of
hospitalization.
Background summary
Delirium, or acute brain failure, presents as an acute confusional state, and
is associated with prolonged hospitalization, increased risk of dementia,
institutionalization and mortality, ultimately resulting in burden of disease
and an increase of costs. Early detection of delirium would allow for early
treatment and could improve patient outcomes, but delirium is often not
recognized and treatment is therefore delayed or not applied at all.
Additionally, current screening tools are subjective, so an alternative, more
objective diagnostic tool for early delirium detection is desired. The
DeltaScan, a CE-certified device to detect delirium using brief
electro-encephalography (EEG) recording, appears to have diagnostic properties
that outperform currently used screening tools.
Study objective
To quantify the impact of the use of DeltaScan on patient outcome (duration of
admission) in patients with high risk of delirium compared to the currently
used delirium screening tools.
Study design
Single blinded randomized trial, total included persons 388.
194 patients intervention group, 1194 patients control group (regular delirium
screening) randomly allocated with REDCap.
Intervention
DeltaScan, EEG scan for 2 minutes / 2 times a day
Study burden and risks
During the intervention period EEG recordings using the CE-certified DeltaScan
will be made using a strip with EEG electrodes that will be mounted to the head
using self-adhesive gel. The EEG recording will be performed two times daily
and will take 2 minutes. During the usual care period patients will receive the
standard delirium
screening tool for delirium assessment by a nurse. This assessment will be
performed two times daily and take 2 minutes. Based on the above we consider
the burden to participants in this study to be minimal.
Soestwetering 1
Utrecht 3543 AZ
NL
Soestwetering 1
Utrecht 3543 AZ
NL
Listed location countries
Age
Inclusion criteria
Patient admitted to our hospital with a hipfracture > 70 years
Exclusion criteria
• Acute macro brain injury in 6 weeks prior to the DeltaScan measurement (such
as traumatic brain injury).
• Admitted because of a primary neurological or neurosurgical disease or
postanoxic encephalopathy
Patients who cannot clinically be assessed for delirium, e.g. due to a language
barrier or deafness.
• Patients using lithium or Clozapine
• Patients with a metal plate or a metal device in the head
• Known pre-existing dementia.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT03735940(trial1)&NCT03735927(trial2) |
| CCMO | NL76875.100.21 |