This randomized controlled trial aims to study the effect of implementation of EEG based encephalopathy detection (DeltaScan, Prolira, Utrecht, The Netherlands, hereafter: DeltaScan) on relevant clinical endpoints (ICU length of stay) as well as the…
ID
Source
Brief title
Condition
- Deliria (incl confusion)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary endpoint is the ICU length of stay, which will be measured in hours.
Secondary outcome
Secondary endpoints observed during ICU stay:
delirium incidence, encephalopathy/delirium/coma-free days, cumulative dose of
sedatives, opioids and antipsychotics, incidence of accidental removal of
lines/tubes/drains by patient, incidence and duration of use of physical
restraints, ventilator free days, organ support free days, ICU mortality
Secondary endpoints observed after ICU stay: ICU readmission, hospital length
of stay, hospital mortality, 90 day mortality, 1 year self assessed quality of
life, cognitive function, depressive symptoms and mobility/physical
functioning.
Background summary
Delirium is an acute encephalopathy that manifests clinically as a disorder of
attention, awareness and other cognitive functions. It is triggered by
underlying somatic disorders and has a distinguishable electroencephalographic
(EEG) signature known as polymorphic delta activity. In recent years, an MDR
certified medical device, called Deltascan, has become available that can
detect the typical EEG changes seen in acute encephalopathy. Traditional
clinical delirium screening instruments are known to have limited sensitivity,
in particular for detecting hypoactive delirium. We hypothesize that adding EEG
based encephalopathy detection to clinical observation scales increases the
sensitivity and results in earlier detection of delirium and subsyndromal
delirium, resulting in improved clinical outcomes of critically ill patients,
such as delirium duration, ICU length of stay or survival.
Study objective
This randomized controlled trial aims to study the effect of implementation of
EEG based encephalopathy detection (DeltaScan, Prolira, Utrecht, The
Netherlands, hereafter: DeltaScan) on relevant clinical endpoints (ICU length
of stay) as well as the effect on delirium management decision by ICU staff, in
a mixed medical and surgical intensive care unit population that is typical for
Western European hospitals.
Study design
This studiy is a randomized controlled trial, where patients are assigned to
either an intervention group or a control group. Control group recieves usual
care, where the patients* medical team obtains regular delirium screening. The
intervention group recieves usual care plus twice daily DeltaScan measurements.
During the daily medical rounds, the DeltaScan results will be presented to the
patients* medical team together with decision support, consisting of DeltaScan
trend interpretation and protocol-based suggestions for evaluation of
underlying delirium cause.
In the control group, a team of researchers will obtain DeltaScan measurements
twice daily. These measurements will only be recorded in the electronic case
record form (eCRF), but not in the patients* electronic medical records.
Because DeltaScan may detect encephalopathy before clinical symptoms emerge, it
is necessary to obtain DeltaScan measurements in both groups, to avoid a false
comparison of delirium duration between the groups. In patients only followed
with *usual care*, encephalopathy / delirium could potentially be detected
later or not at all compared to when DeltaScan would be used. This could result
in falsely increased delirium duration in patients who undergo DeltaScan
measurements.
Intervention
In the intervention group, the DeltaScan measurement result will be visually
presented to the medical team in the patient data management system (PDMS),
during daily medical rounds. PDMS then suggests appropriate diagnostic or
therapeutic interventions, based on the measurements and the department's
delirium protocol.
To make fair comparisons between the groups, the study team will also measure
patients in the control group with DeltaScan twice daily, but will not disclose
the result to the patients' medical team. Also, PDMS will not show decision
support suggestions. This prevents unwanted effects of the DeltaScan
measurements on the control subjects' medical treatment. The medical team will
use daily clinical routines, based on the department's delirium protocol.
This method ensures a proper comparison of delirium incidence and - duration
between groups, without bleed-over of the potential effect of the DeltaScan
measurements to the control group (routine care). This method also enables us
to analyse the effect of DeltaScan on decisions made by the patients' medical
team regarding diagnostic interventions to detect underlying causes of
delirium.
Study burden and risks
In this study, it is not expected that randomization to the intervention group
adds risk for patients. This is a study of a diagnostic intervention with
additional encephalopathy/delirium observations consisting of a short (90
seconds) EEG measurement, which does not harm the patient. Clinicians will
receive protocol-based decision support alongside the diagnostic observation.
No additional medical treatments will be conducted as part of the study
protocol.
Els Borst-Eilersplein 275
Den Haag 2545 AA
NL
Els Borst-Eilersplein 275
Den Haag 2545 AA
NL
Listed location countries
Age
Inclusion criteria
Adult (18 years or above) patient admitted to the intensive care unit
ICU length of stay anticipated to be 48h or longer from time of inclusion
Written informed consent by patient or representative
Exclusion criteria
- More than 48 hours have elapsed since the patient was first eligible to undergo a DeltaScan measurement after ICU admission. (A patient is eligible for DeltaScan measurements if they are a. able to cooperate with simple instructions AND b. are alert or mildly sedated no deeper than a Richmond Agitation and Sedation Score (RASS) of -2.) Admission for * -out-of-hospital cardiac arrest* -status epilepticus* -hemorrhagic or ischemic stroke* -increased intracranial pressure -head trauma Recent intracranial neurosurgery (<30 days prior to inclusion) Known space-occupying lesions in the brain or skull Metal implants in brain or skull Diagnosis of dementia or Parkinson*s disease Inpatient from nursing home Lithium use (<30 days prior to inclusion) Imminent death or palliative care phase Patients and their legal representatives both do not understand Dutch or English Participation in the EARLY DELTRA trial <90 days ago
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 | NCT05403268 |
| CCMO | NL78854.041.21 |