Traumatic Brain Injury (TBI)NCT02172703
Non-invasive Brain Pressure Monitoring After Trauma or Hemorrhage
A study testing Non-invasive ICP measurement device in people with Traumatic Brain Injury (TBI) and Subarachnoid Hemorrhage (SAH), run by Javier Fandino, MD at 1 site in Switzerland.
Trial summary
Introduction: Increased intracranial pressure (ICP) is considered to be the most important intracranial mechanism causing secondary injury in patients admitted after acute traumatic brain injury (TBI) and intracranial haemorrhage (ICB) including subarachnoid haemorrhage (SAH). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Traumatic Brain Injury (TBI), Subarachnoid Hemorrhage (SAH)
- What is being tested?
- Non-invasive ICP measurement device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteSwitzerland
- Study dates
- Feb 2014to Jul 2015
- 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
- Adult patients, age ≥ 18 years, admitted after TBI or SAH at the Neurosurgical Department, Kantonsspital Aarau, Switzerland.
- Patients under sedation and ICP monitoring
- Informed consent will be obtained from the relatives prior to initiation of the measurements.
- study inclusion/informed consent from relatives possible between hour 24 to 72 after admission to the hospital
Who cannot join
- Age < 18 years at study entry.
- Patients with wounds, scars including the front orbital region.
- Perforating or penetrating mechanism of TBI
- Patients with orbital injury or abnormal blood flow in both Ophthalmic Arteries
- Patients with previous retina surgery
- Patients with previous cataract surgery
- Patients with any known ocular condition that may be worsened by sustained eye pressure in the opinion of the subject's ophthalmologist
- Patients with radiological signs of calcification or atheromatose plaques in the internal carotid artery detected by CT or angiography (performed prior and independently of the study)
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Kantonsspital Aarau, Department of Neurosurgery
Aarau, Canton of Aargau, 5001
About this study
Official title: Validation of Non-invasive Absolute Intracranial Pressure Monitoring in Patients After Traumatic Brain Injury and Subarachnoid Hemorrhage
Introduction: Increased intracranial pressure (ICP) is considered to be the most important intracranial mechanism causing secondary injury in patients admitted after acute traumatic brain injury (TBI) and intracranial haemorrhage (ICB) including subarachnoid haemorrhage (SAH). Currently, ICP can be measured and monitored only using invasive techniques. The two ICP measurement methods available - intraventricular and intraparenchymal - require both a neurosurgical procedure in order to implant the catheter and probes within the brain. The invasiveness of current methods for ICP measurement limits the diagnoses reliability of many neurological conditions in which intracranial hypertension is a treatable adverse event. A reliable, accurate and precise non-invasive method to measure ICP would be of considerable clinical value, enabling ICP measurement without the need of a surgical intervention.
Aim:
Read more
The aim of this study is to validate a novel non-invasive ICP measurement device by comparing its measurement with the "gold standard" invasive ICP-measurement by intracranial probe. The device used in this study has been been developed in the Telematic Science Laboratory at the Kaunas University of Technology, Lithuania.
Methods:
The non-invasive ICP measurement method will be assessed prospectively using repeatable simultaneous non-invasive and invasive (standard with intracranial probe) ICP measurements on patients presenting with TBI and SAH. The device method is based on two-depth transcranial doppler (TCD) technique for simultaneously measuring flow velocities in the intracranial and extracranial segments of the ophthalmic artery (OA). The intracranial segment of the OA is compressed by ICP and the extracranial segment of the OA is compressed by the pressure Pe externally applied by the device. Two-depth TCD device is used as an accurate indicator of the balance point (Pe = ICP) when the measured parameters of blood flow velocity waveforms in the intracranial and extracranial segments of OA are identical. The device has the same ultrasound transmission parameters as existing TCD devices and meets all patient safety criteria.
- Being tested
- Non-invasive ICP measurement device
- Keywords
- TBI, SAH, ICP, non invasive measurement
- Medical subject headings
- Brain Injuries, Traumatic, Subarachnoid Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-invasive ICP measurement deviceDevice
Also called NON-INVASIVE ICP ABSOLUTE VALUE METER, (Vittamed 205)
The non-invasive ICP measurement device used in this study has been developed in the Telematic Science Laboratory at the Kaunas University of Technology, Lithuania.
The non-invasive method is based on two-depth TCD technique for simultaneously measuring flow velocities in the intracranial and extracranial segments of the ophthalmic artery (OA).
| Study group | Role | What they receive |
|---|---|---|
| Non-invasive ICP measurement | Other | non-invasive ICP measurement with NON-INVASIVE ICP ABSOLUTE VALUE METER (carried out simultainusly with standard invasive ICP measurement catheter and probes) Receives: Device: Non-invasive ICP measurement device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Simultaneously measured non-invasive and invasive ICP values in mmHg (millimeters of mercury)
Physiological parameters of TBI or SAH patients of primary interest are simultaneously measured paired non-invasive and invasive ICP values.
New measurement is only initiated if ICP changes for more than 4mmHg in comparison to proceeding measurement.
Measured: Max. 3 times/day - approx. 24hours to 30 days after addmission (as long as patient is monitored with invasive ICPprobe)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2014 (estimated)
- Study startFeb 2014
- Primary completionJul 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Brain Injury (TBI)Studies 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Javier Fandino, MD
- Sponsor type
- University, hospital or other
- Collaborators
- Kaunas University of Technology
- Responsible party
- Sponsor-investigator, Javier Fandino, MD, Kantonsspital Aarau
- Investigators
- Javier Fandino, M.D., Principal investigator, Department of Neurosurgery, Kantonsspital Aarau, Aarau, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02172703
- Sponsor's protocol ID
- aICP_CH_TBI_SAH
- Status last verified
- Jul 2015
- First submitted
- 10 Jun 2014
- Last updated
- 8 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of Non-invasive Absolute Intracranial Pressure Monitoring in Patients After Traumatic Brain Injury and Subarachnoid Hemorrhage
- ClinicalTrials.gov ID
- NCT02172703
- Acronym / sponsor ID
- aICP_CH_TBI_SAH
- Keywords
- TBI, SAH, ICP, non invasive measurement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Javier Fandino, MDUniversity, hospital or other
- Collaborators
- Kaunas University of Technology
- Study start
- Feb 2014
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 24 Jun 2014 (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.
Introduction: Increased intracranial pressure (ICP) is considered to be the most important intracranial mechanism causing secondary injury in patients admitted after acute traumatic brain injury (TBI) and intracranial haemorrhage (ICB) including subarachnoid haemorrhage (SAH). Currently, ICP can be measured and monitored only using invasive techniques. The two ICP measurement methods available - intraventricular and intraparenchymal - require both a neurosurgical procedure in order to implant the catheter and probes within the brain. The invasiveness of current methods for ICP measurement limits the diagnoses reliability of many neurological conditions in which intracranial hypertension is a treatable adverse event. A reliable, accurate and precise non-invasive method to measure ICP would be of considerable clinical value, enabling ICP measurement without the need of a surgical intervention.
Aim:
The aim of this study is to validate a novel non-invasive ICP measurement device by comparing its measurement with the "gold standard" invasive ICP-measurement by intracranial probe. The device used in this study has been been developed in the Telematic Science Laboratory at the Kaunas University of Technology, Lithuania.
Methods:
The non-invasive ICP measurement method will be assessed prospectively using repeatable simultaneous non-invasive and invasive (standard with intracranial probe) ICP measurements on patients presenting with TBI and SAH. The device method is based on two-depth transcranial doppler (TCD) technique for simultaneously measuring flow velocities in the intracranial and extracranial segments of the ophthalmic artery (OA). The intracranial segment of the OA is compressed by ICP and the extracranial segment of the OA is compressed by the pressure Pe externally applied by the device. Two-depth TCD device is used as an accurate indicator of the balance point (Pe = ICP) when the measured parameters of blood flow velocity waveforms in the intracranial and extracranial segments of OA are identical. The device has the same ultrasound transmission parameters as existing TCD devices and meets all patient safety criteria.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Non-invasive ICP measurement | Other | Device: Non-invasive ICP measurement devicenon-invasive ICP measurement with NON-INVASIVE ICP ABSOLUTE VALUE METER (carried out simultainusly with standard invasive ICP measurement catheter and probes) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult patients, age ≥ 18 years, admitted after TBI or SAH at the Neurosurgical Department, Kantonsspital Aarau, Switzerland.
- Patients under sedation and ICP monitoring
- Informed consent will be obtained from the relatives prior to initiation of the measurements.
- study inclusion/informed consent from relatives possible between hour 24 to 72 after admission to the hospital
Key exclusion criteria (8 listed)
- Age < 18 years at study entry.
- Patients with wounds, scars including the front orbital region.
- Perforating or penetrating mechanism of TBI
- Patients with orbital injury or abnormal blood flow in both Ophthalmic Arteries
- Patients with previous retina surgery
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 |
|---|---|---|
| Non-invasive ICP measurement deviceAlso: NON-INVASIVE ICP ABSOLUTE VALUE METER, (Vittamed 205)The non-invasive ICP measurement device used in this study has been developed in the Telematic Science Laboratory at the Kaunas University of Technology, Lithuania. The non-invasive method is based on two-depth TCD technique for simultaneously measuring flow velocities in the intracranial and extracranial segments of the ophthalmic artery (OA). | Device | Non-invasive ICP measurement |
Primary outcome
Simultaneously measured non-invasive and invasive ICP values in mmHg (millimeters of mercury)
Time frame: Max. 3 times/day - approx. 24hours to 30 days after addmission (as long as patient is monitored with invasive ICPprobe)
Physiological parameters of TBI or SAH patients of primary interest are simultaneously measured paired non-invasive and invasive ICP values. New measurement is only initiated if ICP changes for more than 4mmHg in comparison to proceeding measurement.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2015.
Related trials for Traumatic Brain Injury (TBI)
Active, not recruitingObservational study
Transforming Research and Clinical Knowledge in Traumatic Brain Injury Epileptogenesis Project (TRACK-TBI EPI)
Traumatic Brain Injury, Post-traumatic Epilepsy
Enrolling by invitationPhase 1
Pilot Safety and Exploratory Efficacy of PSC-05 for the Treatment of Chronic Mild Traumatic Brain Injury
Mild Traumatic Brain Injury
RecruitingObservational study
Intracranial Pressure Monitoring in Moderate Traumatic Brain Injury
Moderate Traumatic Brain Injury
Not yet recruitingPhase 1
Nanopulse Laser Therapy
TBI (Traumatic Brain Injury)
Recruiting
Evaluation of Cognitive Behavioral Therapy for Insomnia (CBT-I) in Individuals With Mild Traumatic Brain Injury (mTBI)
Sleep Architecture, Mild Traumatic Brain Injury
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.
Javier Fandino, M.D. principal investigator
Department of Neurosurgery, Kantonsspital Aarau, Aarau, Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non-invasive ICP measurement device in people with Traumatic Brain Injury (TBI) and Subarachnoid Hemorrhage (SAH), run by Javier Fandino, MD at 1 site in Switzerland.
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 4 inclusion and 8 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: finished, as of the sponsor's last update on 8 Jul 2015. 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 Switzerland. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Simultaneously measured non-invasive and invasive ICP values in mmHg (millimeters of mercury) (time frame: Max. 3 times/day - approx. 24hours to 30 days after addmission (as long as patient is monitored with invasive ICPprobe)). 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 8 Jul 2015.