Acute Neurological InsultNCT02545816
Comparing Simplified EEG Monitoring Tool With Standard EEG Monitoring in Patients With Acute Neurological Insult
A study testing Bispectral index (BIS) EEG monitoring in people with Acute Neurological Insult, run by Hasselt University at 1 site in Belgium.
Trial summary
After any acute brain injury, a primary pathophysiological response arises, enabling the brain to develop seizures and/or a status epilepticus (SE). These are frequently reported in patients admitted to the intensive care unit (ICU) with traumatic brain injury and brain injury caused by subarachnoid or intracerebral… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Neurological Insult
- What is being tested?
- Bispectral index (BIS) EEG monitoring
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteBelgium
- Study dates
- May 2015to May 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients (age ≥ 18 years) admitted to the ICU with an acute neurological insult which will be sedated/ventilated (Glasgow Coma Scale (GCS) ≤ 8).
- Ability to place BIS sensors on the forehead
- Written informed consent form has to be obtained from the patient's next of kin and has to be reconfirmed if the patient regains consciousness
Who cannot join
- Age < 18 years
- Inability to place BIS sensors on the forehead (e.g. due to frontal decompression)
Trial locations and contacts
1 site in 1 country.
Ward Eertmans, drs. contact
Frank Jans, prof. dr. contact
Belgium1 site, 1 recruiting
- Recruiting
Ziekenhuis Oost-Limburg
Genk, 3830
Ward Eertmans, drs., ward.eertmans@uhasselt.be
Frank Jans, prof. dr.
About this study
Official title: A Validation Study to Compare Bispectral Index EEG Monitoring With Full EEG in Patients With an Acute Neurological Insult
After any acute brain injury, a primary pathophysiological response arises, enabling the brain to develop seizures and/or a status epilepticus (SE). These are frequently reported in patients admitted to the intensive care unit (ICU) with traumatic brain injury and brain injury caused by subarachnoid or intracerebral hemorrhage. Seizures can be presented without any clinical motor signs, which are then termed as nonconvulsive, and therefore remain frequently clinically unrecognized. As such, it is of great importance that these patients are diagnosed as early as possible since the increased metabolic demand and blood flow associated with an epileptic insult may further compromise the brain at risk. Thus far, continuous EEG (cEEG) is the only clinical instrument that is able to detect the development of early epileptic activity. Unfortunately, cEEG is not available in most ICUs and is labor-intensive, expensive and difficult to interpret for non-trained physicians. Therefore, a more simple and prognostic accurate EEG device is highly warranted to detect seizures in an early stage so that patients might benefit from a specific and early treatment. A validation study in comatose patients with an acute neurological insult will be conducted to provide evidence that simplified Bispectral Index EEG monitoring has the potential to detect epileptic activity as reliable as its gold standard, full EEG monitoring. Thereby, BIS EEG monitoring could possibly be used to facilitate the prognostication and management of epileptic seizures in this patient cohort which could eventually improve the clinical outcome.
- Conditions
- Acute Neurological Insult
- Being tested
- Bispectral index (BIS) EEG monitoring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bispectral index (BIS) EEG monitoringDevice
The Bispectral Index (BIS) EEG monitor is a simplified EEG monitoring device which was originally designed to monitor the depth of hypnosis during general anesthesia. It does this by analyzing changes in the processed electroencephalogram (EEG) which occur with the hypnotic state and creating a measure (or index) indicative of these changes. A number between 0 and 100 is derived, with values above 70 associated with an awake state. The monitor also provides a single channel EEG, an electromyogram (EMG) and an index of signal quality (SQI), all in real time.
| Study group | Role | What they receive |
|---|---|---|
| study group | Other | Patients (age ≥ 18 years) admitted to the ICU with an acute neurological insult which will be sedated/ventilated (Glasgow Coma Scale (GCS) ≤ 8). Receives: Device: Bispectral index (BIS) EEG monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
A comparison between BIS derived EEG and standard full EEG
Unfiltered BIS derived EEG data from 15 minutes before or after the acquisition of a full intermittent EEG will be used to compare BIS derived EEG traces with full intermittent EEG traces. These data will be (retrospectively) analyzed by experienced neurophysiologists for the presence of seizures and/or status epilepticus.
Measured: 15 minutes before or after the acquisition of standard full EEG monitoring.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2015 (estimated)
- Study startMay 2015
- Primary completionMay 2018 (estimated)
- Study completionMay 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Neurological InsultStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hasselt University
- Sponsor type
- University, hospital or other
- Collaborators
- Ziekenhuis Oost-Limburg
- Responsible party
- Principal investigator, prof. dr. Frank Jans, Hasselt University
- Investigators
- Frank Jans, prof. dr., Principal investigator, Ziekenhuis Oost-Limburg, Hasselt UniversityCathy De Deyne, prof. dr., Study chair, Ziekenhuis Oost-Limburg, Hasselt UniversityWillem Boer, dr., Study chair, Ziekenhuis Oost-LimburgPascal Vanelderen, prof. dr, Study chair, Ziekenhuis Oost-Limburg, Hasselt UniversityWard Eertmans, drs., Study chair, Hasselt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02545816
- Sponsor's protocol ID
- BISZOL1
- Status last verified
- Mar 2018
- First submitted
- 20 Aug 2015
- Last updated
- 27 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Validation Study to Compare Bispectral Index EEG Monitoring With Full EEG in Patients With an Acute Neurological Insult
- ClinicalTrials.gov ID
- NCT02545816
- Acronym / sponsor ID
- BISZOL1
- Conditions
- Acute Neurological Insult
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Hasselt UniversityUniversity, hospital or other
- Collaborators
- Ziekenhuis Oost-Limburg
- Study start
- May 2015
- Primary completion
- May 2018 (estimated)
- Study completion
- May 2018 (estimated)
- First posted
- 10 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
After any acute brain injury, a primary pathophysiological response arises, enabling the brain to develop seizures and/or a status epilepticus (SE). These are frequently reported in patients admitted to the intensive care unit (ICU) with traumatic brain injury and brain injury caused by subarachnoid or intracerebral hemorrhage. Seizures can be presented without any clinical motor signs, which are then termed as nonconvulsive, and therefore remain frequently clinically unrecognized. As such, it is of great importance that these patients are diagnosed as early as possible since the increased metabolic demand and blood flow associated with an epileptic insult may further compromise the brain at risk. Thus far, continuous EEG (cEEG) is the only clinical instrument that is able to detect the development of early epileptic activity. Unfortunately, cEEG is not available in most ICUs and is labor-intensive, expensive and difficult to interpret for non-trained physicians. Therefore, a more simple and prognostic accurate EEG device is highly warranted to detect seizures in an early stage so that patients might benefit from a specific and early treatment. A validation study in comatose patients with an acute neurological insult will be conducted to provide evidence that simplified Bispectral Index EEG monitoring has the potential to detect epileptic activity as reliable as its gold standard, full EEG monitoring. Thereby, BIS EEG monitoring could possibly be used to facilitate the prognostication and management of epileptic seizures in this patient cohort which could eventually improve the clinical outcome.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| study group | Other | Device: Bispectral index (BIS) EEG monitoringPatients (age ≥ 18 years) admitted to the ICU with an acute neurological insult which will be sedated/ventilated (Glasgow Coma Scale (GCS) ≤ 8). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients (age ≥ 18 years) admitted to the ICU with an acute neurological insult which will be sedated/ventilated (Glasgow Coma Scale (GCS) ≤ 8).
- Ability to place BIS sensors on the forehead
- Written informed consent form has to be obtained from the patient's next of kin and has to be reconfirmed if the patient regains consciousness
Key exclusion criteria (2 listed)
- Age < 18 years
- Inability to place BIS sensors on the forehead (e.g. due to frontal decompression)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bispectral index (BIS) EEG monitoringThe Bispectral Index (BIS) EEG monitor is a simplified EEG monitoring device which was originally designed to monitor the depth of hypnosis during general anesthesia. It does this by analyzing changes in the processed electroencephalogram (EEG) which occur with the hypnotic state and creating a measure (or index) indicative of these changes. A number between 0 and 100 is derived, with values above 70 associated with an awake state. The monitor also provides a single channel EEG, an electromyogram (EMG) and an index of signal quality (SQI), all in real time. | Device | study group |
Primary outcome
A comparison between BIS derived EEG and standard full EEG
Time frame: 15 minutes before or after the acquisition of standard full EEG monitoring.
Unfiltered BIS derived EEG data from 15 minutes before or after the acquisition of a full intermittent EEG will be used to compare BIS derived EEG traces with full intermittent EEG traces. These data will be (retrospectively) analyzed by experienced neurophysiologists for the presence of seizures and/or status epilepticus.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2018.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ward Eertmans, drs. contact
Frank Jans, prof. dr. contact
Frank Jans, prof. dr. principal investigator
Ziekenhuis Oost-Limburg, Hasselt University
Cathy De Deyne, prof. dr. study chair
Ziekenhuis Oost-Limburg, Hasselt University
Willem Boer, dr. study chair
Ziekenhuis Oost-Limburg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bispectral index (BIS) EEG monitoring in people with Acute Neurological Insult, run by Hasselt University at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ward Eertmans, drs. (frank.jans@uhasselt.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
A comparison between BIS derived EEG and standard full EEG (time frame: 15 minutes before or after the acquisition of standard full EEG monitoring.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2018.