<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03227354</url>
  </required_header>
  <id_info>
    <org_study_id>aICP Validation 2</org_study_id>
    <nct_id>NCT03227354</nct_id>
  </id_info>
  <brief_title>Validation of Non-invasive Absolute Intracranial Pressure Monitoring</brief_title>
  <official_title>Open Study on the Validation of Non-invasive Absolute Intracranial Pressure Monitoring in Patients After Traumatic Brain Injury and Subarachnoid Hemorrhage</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kienzler Jenny</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Swiss National Science Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Kantonsspital Aarau</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Primary objective of this study is to assess the accuracy and precision of intracranial&#xD;
      pressure (ICP) measurement in patients after traumatic brain injury and subarachnoid&#xD;
      hemorrhage when using simultaneous, non-invasive measurement compared to standard, invasive,&#xD;
      measurement.&#xD;
&#xD;
      Secondary objective: is to assess the correlation of intracranial pressure (ICP) measurement&#xD;
      in patients after traumatic brain injury and subarachnoid hemorrhage between simultaneous,&#xD;
      non-invasive measurement and standard, invasive,measurement&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Currently, ICP (Intracranial Pressure) can be measured only using invasive techniques. In a&#xD;
      previous (pilot study) a non-invasive technique for measurement of ICP was investigated&#xD;
      (based on simultaneously measuring of ophthalmic artery (OA) blood flow parameters in the&#xD;
      intracranial (IOA) and extracranial (EOA) segments of the OA with two-depth transcranial&#xD;
      Doppler (TCD)). Based on the good results of the previous study, the study should be repeated&#xD;
      in order to further validate the new method in more patients and to obtain additional insight&#xD;
      with more measurements.&#xD;
&#xD;
      This single centre, observational comparative study shall investigate a new non-invasive ICP&#xD;
      absolute value measurement method in patients presenting with TBI, ICH, or secondary edema&#xD;
      after stroke or Subarachnoid Hemorrhage (SAH) compared to current standard invasive ICP&#xD;
      monitoring methods.Suitable patients are to be recruited soonest after their referral or&#xD;
      admission to the Department of Neurosurgery at the Kantonsspital Aarau. Measurement will be&#xD;
      done either at the surgical Intensive Care Unit, Stroke Unit (&quot;SIC&quot;) or Neurosurgical&#xD;
      Intermediate Care Unit (&quot;NCW&quot;). All measurements will be performed on intubated and sedated&#xD;
      patients with invasive ICP Monitoring trough an intraparenchymatous or intraventricular&#xD;
      probe. In the same patient, several measurements will be allowed daily.&#xD;
&#xD;
      The non-invasive technique for measurement of ICP is based on simultaneously measuring of an&#xD;
      ophthalmic artery (OA) blood flow parameters in the intracranial (IOA) and extracranial (EOA)&#xD;
      segments of the OA with two-depth transorbital Doppler (TCD) measurements including&#xD;
      mechanical head frame for fixation of ultrasonic transducer on the closed eye lid. ICP&#xD;
      pressure will be measured non-invasively by using Vittamed 205® device. This device has CE&#xD;
      marking since July 2014.&#xD;
&#xD;
      It is planned to recruit 25 patients and to collect 69 independent paired non-invasive and&#xD;
      invasive ICP measurements during a 24 months period after study approval.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">September 2017</start_date>
  <completion_date type="Anticipated">September 2019</completion_date>
  <primary_completion_date type="Anticipated">September 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Absolute intracranial pressure</measure>
    <time_frame>35 minutes per measurement</time_frame>
    <description>absolute intracranial ICP, measured simultaneously with the non-invasive and the standard invasive method</description>
  </primary_outcome>
  <other_outcome>
    <measure>Safety outcome</measure>
    <time_frame>during measurements</time_frame>
    <description>Incidence of device related Adverse Events and Serious Adverse Events</description>
  </other_outcome>
  <enrollment type="Anticipated">25</enrollment>
  <condition>Intracranial Pressure Increase</condition>
  <condition>Traumatic Brain Injury</condition>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Vittamed 205</intervention_name>
    <description>non-invasive Intracranial Pressure measurement</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Adult patients, age ≥ 18 years, after Traumatic Brain Injury, Intrcranial Hemorrhage,&#xD;
        secondary edema after stroke or SAH&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult patients, age ≥ 18 years, admitted after TBI, ICH, secondary edema after stroke&#xD;
             or SAH at the Departments of Neurosurgery or Neurology, Kantonsspital Aarau,&#xD;
             Switzerland.&#xD;
&#xD;
          -  Patients under sedation and ICP monitoring&#xD;
&#xD;
          -  Informed consent obtained from the legally authorized representative prior initiation&#xD;
             of the measurements.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Age &lt; 18 years at study entry.&#xD;
&#xD;
          -  Patients with wounds, scars including the front orbital region.&#xD;
&#xD;
          -  Perforating or penetrating mechanism of TBI&#xD;
&#xD;
          -  Patients with orbital injury or abnormal blood flow in both Ophthalmic Arteries&#xD;
&#xD;
          -  Patients with previous retina surgery&#xD;
&#xD;
          -  Patients with previous cataract surgery&#xD;
&#xD;
          -  Patients with any known ocular condition that may be worsened by sustained eye&#xD;
             pressure in the opinion of the subject's ophthalmologist&#xD;
&#xD;
          -  Patients with radiological signs of calcification or atheromatose plaques in the&#xD;
             internal carotid artery detected by CT or angiography (performed prior and&#xD;
             independently of the study)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>jenny kienzler</last_name>
    <role>Principal Investigator</role>
    <affiliation>Kantonsspital Aarau</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Jenny Kienzler</last_name>
    <phone>+41 62 838 58 72</phone>
    <email>jenny.kienzler@ksa.ch</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>javier Fandino</last_name>
    <phone>+41 62 838 66 90</phone>
    <email>javier.fandino@kas.ch</email>
  </overall_contact_backup>
  <verification_date>July 2017</verification_date>
  <study_first_submitted>July 20, 2017</study_first_submitted>
  <study_first_submitted_qc>July 20, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 24, 2017</study_first_posted>
  <last_update_submitted>July 26, 2017</last_update_submitted>
  <last_update_submitted_qc>July 26, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">July 28, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Kantonsspital Aarau</investigator_affiliation>
    <investigator_full_name>Kienzler Jenny</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Medical Device</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Brain Injuries</mesh_term>
    <mesh_term>Brain Injuries, Traumatic</mesh_term>
    <mesh_term>Intracranial Hypertension</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03227354
org study id: aICP Validation 2
nct id: NCT03227354
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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
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.
observational model: Cohort
time perspective: Prospective
measure: Absolute intracranial pressure
time frame: 35 minutes per measurement
description: absolute intracranial ICP, measured simultaneously with the non-invasive and the standard invasive method
measure: Safety outcome
time frame: during measurements
description: Incidence of device related Adverse Events and Serious Adverse Events
intervention type: Device
intervention name: Vittamed 205
description: non-invasive Intracranial Pressure measurement
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: jenny kienzler
role: Principal Investigator
affiliation: Kantonsspital Aarau
last name: Jenny Kienzler
phone: +41 62 838 58 72
email: jenny.kienzler@ksa.ch
last name: javier Fandino
phone: +41 62 838 66 90
email: javier.fandino@kas.ch
responsible party type: Sponsor-Investigator
investigator affiliation: Kantonsspital Aarau
investigator full name: Kienzler Jenny
investigator title: Principal Investigator
mesh term: Brain Injuries
mesh term: Brain Injuries, Traumatic
mesh term: Intracranial Hypertension
sharing ipd: No