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Validation of Non-invasive Absolute Intracranial Pressure Monitoring

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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
Sponsor:
Collaborator:
Swiss National Science Foundation
Information provided by (Responsible Party):
Kienzler Jenny, Kantonsspital Aarau

Brief 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.

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

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.


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Study Type : Observational
Estimated Enrollment : 25 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine



Intervention Details:
  • Device: Vittamed 205
    non-invasive Intracranial Pressure measurement


Primary Outcome Measures :
  1. Absolute intracranial pressure [ Time Frame: 35 minutes per measurement ]
    absolute intracranial ICP, measured simultaneously with the non-invasive and the standard invasive method


Other Outcome Measures:
  1. Safety outcome [ Time Frame: during measurements ]
    Incidence of device related Adverse Events and Serious Adverse Events



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult patients, age ≥ 18 years, after Traumatic Brain Injury, Intrcranial Hemorrhage, secondary edema after stroke or SAH
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03227354


Contacts
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Contact: Jenny Kienzler +41 62 838 58 72 jenny.kienzler@ksa.ch
Contact: javier Fandino +41 62 838 66 90 javier.fandino@kas.ch

Sponsors and Collaborators
Kienzler Jenny
Swiss National Science Foundation
Investigators
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Principal Investigator: jenny kienzler Kantonsspital Aarau

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Responsible Party: Kienzler Jenny, Principal Investigator, Kantonsspital Aarau
ClinicalTrials.gov Identifier: NCT03227354     History of Changes
Other Study ID Numbers: aICP Validation 2
First Posted: July 24, 2017    Key Record Dates
Last Update Posted: July 28, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Kienzler Jenny, Kantonsspital Aarau:
Medical Device
Additional relevant MeSH terms:
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Brain Injuries
Brain Injuries, Traumatic
Intracranial Hypertension
Wounds and Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System