Validation of Non-invasive Absolute Intracranial Pressure Monitoring
|ClinicalTrials.gov Identifier: NCT03227354|
Recruitment Status : Unknown
Verified July 2017 by Kienzler Jenny, Kantonsspital Aarau.
Recruitment status was: Not yet recruiting
First Posted : July 24, 2017
Last Update Posted : July 28, 2017
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
|Condition or disease||Intervention/treatment|
|Intracranial Pressure Increase Traumatic Brain Injury||Device: Vittamed 205|
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 :||Observational|
|Estimated Enrollment :||25 participants|
|Official Title:||Open Study on the Validation of Non-invasive Absolute Intracranial Pressure Monitoring in Patients After Traumatic Brain Injury and Subarachnoid Hemorrhage|
|Estimated Study Start Date :||September 2017|
|Estimated Primary Completion Date :||September 2019|
|Estimated Study Completion Date :||September 2019|
- Device: Vittamed 205
non-invasive Intracranial Pressure measurement
- Absolute intracranial pressure [ Time Frame: 35 minutes per measurement ]absolute intracranial ICP, measured simultaneously with the non-invasive and the standard invasive method
- Safety outcome [ Time Frame: during measurements ]Incidence of device related Adverse Events and Serious Adverse Events
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03227354
|Contact: Jenny Kienzler||+41 62 838 58 firstname.lastname@example.org|
|Contact: javier Fandino||+41 62 838 66 email@example.com|
|Principal Investigator:||jenny kienzler||Kantonsspital Aarau|