- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03227354
Validation of Non-invasive Absolute Intracranial Pressure Monitoring
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
Study Overview
Status
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
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)
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Absolute intracranial pressure
Time Frame: 35 minutes per measurement
|
absolute intracranial ICP, measured simultaneously with the non-invasive and the standard invasive method
|
35 minutes per measurement
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Safety outcome
Time Frame: during measurements
|
Incidence of device related Adverse Events and Serious Adverse Events
|
during measurements
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (ANTICIPATED)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- aICP Validation 2
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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