Intracranial Pressure IncreaseNCT03227354
Validation of Non-invasive Absolute Intracranial Pressure Monitoring
An observational study of Intracranial Pressure Increase and Traumatic Brain Injury, run by Kienzler Jenny.
Trial summary
Primary objective of this study is to assess the accuracy and precision of intracranial pressure (ICP) measurement in patients after traumatic brain injury and subarachnoid hemorrhage when using simultaneous, non-invasive measurement compared to standard, invasive, measurement. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intracranial Pressure Increase, Traumatic Brain Injury
- What is being tested?
- Vittamed 205
- Type of treatment
- Medical device
- How many people
- 25 participants
- Where
- No sites listed yet
- Study dates
- Sep 2017to Sep 2019
- Phase
- Observational
- 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
Study population: Adult patients, age ≥ 18 years, after Traumatic Brain Injury, Intrcranial Hemorrhage, secondary edema after stroke or SAH
Who may be able to join
- Adult patients, age ≥ 18 years, admitted after TBI, ICH, secondary edema after stroke or SAH at the Departments of Neurosurgery or Neurology, Kantonsspital Aarau, Switzerland.
- Patients under sedation and ICP monitoring
- Informed consent obtained from the legally authorized representative prior initiation of the measurements.
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
No sites are listed yet.
About this study
Official title: Open Study on the Validation of Non-invasive Absolute Intracranial Pressure Monitoring in Patients After Traumatic Brain Injury and Subarachnoid Hemorrhage
Primary objective of this study is to assess the accuracy and precision of intracranial pressure (ICP) measurement in patients after traumatic brain injury and subarachnoid hemorrhage when using simultaneous, non-invasive measurement compared to standard, invasive, measurement.
Secondary objective: is to assess the correlation of intracranial pressure (ICP) measurement in patients after traumatic brain injury and subarachnoid hemorrhage between simultaneous, non-invasive measurement and standard, invasive,measurement
Read the detailed description
Currently, ICP (Intracranial Pressure) can be measured only using invasive techniques. In a previous (pilot study) a non-invasive technique for measurement of ICP was investigated (based on simultaneously measuring of ophthalmic artery (OA) blood flow parameters in the intracranial (IOA) and extracranial (EOA) segments of the OA with two-depth transcranial Doppler (TCD)). Based on the good results of the previous study, the study should be repeated in order to further validate the new method in more patients and to obtain additional insight with more measurements.
This single centre, observational comparative study shall investigate a new non-invasive ICP absolute value measurement method in patients presenting with TBI, ICH, or secondary edema after stroke or Subarachnoid Hemorrhage (SAH) compared to current standard invasive ICP monitoring methods.Suitable patients are to be recruited soonest after their referral or admission to the Department of Neurosurgery at the Kantonsspital Aarau. Measurement will be done either at the surgical Intensive Care Unit, Stroke Unit ("SIC") or Neurosurgical Intermediate Care Unit ("NCW"). All measurements will be performed on intubated and sedated patients with invasive ICP Monitoring trough an intraparenchymatous or intraventricular probe. In the same patient, several measurements will be allowed daily.
The non-invasive technique for measurement of ICP is based on simultaneously measuring of an ophthalmic artery (OA) blood flow parameters in the intracranial (IOA) and extracranial (EOA) segments of the OA with two-depth transorbital Doppler (TCD) measurements including mechanical head frame for fixation of ultrasonic transducer on the closed eye lid. ICP pressure will be measured non-invasively by using Vittamed 205® device. This device has CE marking since July 2014.
It is planned to recruit 25 patients and to collect 69 independent paired non-invasive and invasive ICP measurements during a 24 months period after study approval.
- Being tested
- Vittamed 205
- Keywords
- Medical Device
- Medical subject headings
- Intracranial Hypertension, Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vittamed 205Device
non-invasive Intracranial Pressure measurement
What is being measured
The primary outcome is the main question the study is designed to answer.
Absolute intracranial pressure
absolute intracranial ICP, measured simultaneously with the non-invasive and the standard invasive method
Measured: 35 minutes per measurement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2017
- Study startSep 2017 (estimated)
- Primary completionSep 2019 (estimated)
- Study completionSep 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intracranial Pressure IncreaseStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kienzler Jenny
- Sponsor type
- University, hospital or other
- Collaborators
- Swiss National Science Foundation
- Responsible party
- Sponsor-investigator, Kienzler Jenny, Kantonsspital Aarau
- Investigators
- jenny kienzler, Principal investigator, Kantonsspital Aarau
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03227354
- Sponsor's protocol ID
- aICP Validation 2
- Status last verified
- Jul 2017
- First submitted
- 20 Jul 2017
- Last updated
- 28 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Study on the Validation of Non-invasive Absolute Intracranial Pressure Monitoring in Patients After Traumatic Brain Injury and Subarachnoid Hemorrhage
- ClinicalTrials.gov ID
- NCT03227354
- Acronym / sponsor ID
- aICP Validation 2
- Keywords
- Medical Device
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Kienzler JennyUniversity, hospital or other
- Collaborators
- Swiss National Science Foundation
- Study start
- Sep 2017 (estimated)
- Primary completion
- Sep 2019 (estimated)
- Study completion
- Sep 2019 (estimated)
- First posted
- 24 Jul 2017 (actual)
- 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.
Primary objective of this study is to assess the accuracy and precision of intracranial pressure (ICP) measurement in patients after traumatic brain injury and subarachnoid hemorrhage when using simultaneous, non-invasive measurement compared to standard, invasive, measurement.
Secondary objective: is to assess the correlation of intracranial pressure (ICP) measurement in patients after traumatic brain injury and subarachnoid hemorrhage between simultaneous, non-invasive measurement and standard, invasive,measurement
Detailed description
Currently, ICP (Intracranial Pressure) can be measured only using invasive techniques. In a previous (pilot study) a non-invasive technique for measurement of ICP was investigated (based on simultaneously measuring of ophthalmic artery (OA) blood flow parameters in the intracranial (IOA) and extracranial (EOA) segments of the OA with two-depth transcranial Doppler (TCD)). Based on the good results of the previous study, the study should be repeated in order to further validate the new method in more patients and to obtain additional insight with more measurements.
This single centre, observational comparative study shall investigate a new non-invasive ICP absolute value measurement method in patients presenting with TBI, ICH, or secondary edema after stroke or Subarachnoid Hemorrhage (SAH) compared to current standard invasive ICP monitoring methods.Suitable patients are to be recruited soonest after their referral or admission to the Department of Neurosurgery at the Kantonsspital Aarau. Measurement will be done either at the surgical Intensive Care Unit, Stroke Unit ("SIC") or Neurosurgical Intermediate Care Unit ("NCW"). All measurements will be performed on intubated and sedated patients with invasive ICP Monitoring trough an intraparenchymatous or intraventricular probe. In the same patient, several measurements will be allowed daily.
The non-invasive technique for measurement of ICP is based on simultaneously measuring of an ophthalmic artery (OA) blood flow parameters in the intracranial (IOA) and extracranial (EOA) segments of the OA with two-depth transorbital Doppler (TCD) measurements including mechanical head frame for fixation of ultrasonic transducer on the closed eye lid. ICP pressure will be measured non-invasively by using Vittamed 205® device. This device has CE marking since July 2014.
It is planned to recruit 25 patients and to collect 69 independent paired non-invasive and invasive ICP measurements during a 24 months period after study approval.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients, age ≥ 18 years, after Traumatic Brain Injury, Intrcranial Hemorrhage, secondary edema after stroke or SAH
Key inclusion criteria (3 listed)
- Adult patients, age ≥ 18 years, admitted after TBI, ICH, secondary edema after stroke or SAH at the Departments of Neurosurgery or Neurology, Kantonsspital Aarau, Switzerland.
- Patients under sedation and ICP monitoring
- Informed consent obtained from the legally authorized representative prior initiation of the measurements.
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 |
|---|---|---|
| Vittamed 205non-invasive Intracranial Pressure measurement | Device | – |
Primary outcome
Absolute intracranial pressure
Time frame: 35 minutes per measurement
absolute intracranial ICP, measured simultaneously with the non-invasive and the standard invasive method
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2017.
- Individual participant dataSharing planned: No
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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.
jenny kienzler principal investigator
Kantonsspital Aarau
Questions about this trial
What is this clinical trial studying?
An observational study of Intracranial Pressure Increase and Traumatic Brain Injury, run by Kienzler Jenny.
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 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: status not confirmed, as of the sponsor's last update on 28 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
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 Jenny Kienzler (+41 62 838 58 72, jenny.kienzler@ksa.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Absolute intracranial pressure (time frame: 35 minutes per measurement). 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 28 Jul 2017.