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Trial record 14 of 195 for:    Hemorrhage AND SAH

Non-invasive Brain Pressure Monitoring After Trauma or Hemorrhage

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02172703
Recruitment Status : Completed
First Posted : June 24, 2014
Last Update Posted : July 8, 2015
Sponsor:
Collaborator:
Kaunas University of Technology
Information provided by (Responsible Party):
Javier Fandino, MD, Kantonsspital Aarau

Brief Summary:

Introduction: Increased intracranial pressure (ICP) is considered to be the most important intracranial mechanism causing secondary injury in patients admitted after acute traumatic brain injury (TBI) and intracranial haemorrhage (ICB) including subarachnoid haemorrhage (SAH). Currently, ICP can be measured and monitored only using invasive techniques. The two ICP measurement methods available - intraventricular and intraparenchymal - require both a neurosurgical procedure in order to implant the catheter and probes within the brain. The invasiveness of current methods for ICP measurement limits the diagnoses reliability of many neurological conditions in which intracranial hypertension is a treatable adverse event. A reliable, accurate and precise non-invasive method to measure ICP would be of considerable clinical value, enabling ICP measurement without the need of a surgical intervention.

Aim:

The aim of this study is to validate a novel non-invasive ICP measurement device by comparing its measurement with the "gold standard" invasive ICP-measurement by intracranial probe. The device used in this study has been been developed in the Telematic Science Laboratory at the Kaunas University of Technology, Lithuania.

Methods:

The non-invasive ICP measurement method will be assessed prospectively using repeatable simultaneous non-invasive and invasive (standard with intracranial probe) ICP measurements on patients presenting with TBI and SAH. The device method is based on two-depth transcranial doppler (TCD) technique for simultaneously measuring flow velocities in the intracranial and extracranial segments of the ophthalmic artery (OA). The intracranial segment of the OA is compressed by ICP and the extracranial segment of the OA is compressed by the pressure Pe externally applied by the device. Two-depth TCD device is used as an accurate indicator of the balance point (Pe = ICP) when the measured parameters of blood flow velocity waveforms in the intracranial and extracranial segments of OA are identical. The device has the same ultrasound transmission parameters as existing TCD devices and meets all patient safety criteria.


Condition or disease Intervention/treatment Phase
Traumatic Brain Injury (TBI) Subarachnoid Hemorrhage (SAH) Device: Non-invasive ICP measurement device Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Validation of Non-invasive Absolute Intracranial Pressure Monitoring in Patients After Traumatic Brain Injury and Subarachnoid Hemorrhage
Study Start Date : February 2014
Actual Primary Completion Date : July 2015
Actual Study Completion Date : July 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Non-invasive ICP measurement
non-invasive ICP measurement with NON-INVASIVE ICP ABSOLUTE VALUE METER (carried out simultainusly with standard invasive ICP measurement catheter and probes)
Device: Non-invasive ICP measurement device

The non-invasive ICP measurement device used in this study has been developed in the Telematic Science Laboratory at the Kaunas University of Technology, Lithuania.

The non-invasive method is based on two-depth TCD technique for simultaneously measuring flow velocities in the intracranial and extracranial segments of the ophthalmic artery (OA).

Other Names:
  • NON-INVASIVE ICP ABSOLUTE VALUE METER
  • (Vittamed 205)




Primary Outcome Measures :
  1. Simultaneously measured non-invasive and invasive ICP values in mmHg (millimeters of mercury) [ Time Frame: Max. 3 times/day - approx. 24hours to 30 days after addmission (as long as patient is monitored with invasive ICPprobe) ]

    Physiological parameters of TBI or SAH patients of primary interest are simultaneously measured paired non-invasive and invasive ICP values.

    New measurement is only initiated if ICP changes for more than 4mmHg in comparison to proceeding measurement.




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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult patients, age ≥ 18 years, admitted after TBI or SAH at the Neurosurgical Department, Kantonsspital Aarau, Switzerland.
  • Patients under sedation and ICP monitoring
  • Informed consent will be obtained from the relatives prior to initiation of the measurements.
  • study inclusion/informed consent from relatives possible between hour 24 to 72 after admission to the hospital

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): NCT02172703


Locations
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Switzerland
Kantonsspital Aarau, Department of Neurosurgery
Aarau, Aargau, Switzerland, 5001
Sponsors and Collaborators
Javier Fandino, MD
Kaunas University of Technology
Investigators
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Principal Investigator: Javier Fandino, M.D. Department of Neurosurgery, Kantonsspital Aarau, Aarau, Switzerland

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Responsible Party: Javier Fandino, MD, Chairman, Department of Neurosurgery, Kantonsspital Aarau
ClinicalTrials.gov Identifier: NCT02172703     History of Changes
Other Study ID Numbers: aICP_CH_TBI_SAH
First Posted: June 24, 2014    Key Record Dates
Last Update Posted: July 8, 2015
Last Verified: July 2015

Keywords provided by Javier Fandino, MD, Kantonsspital Aarau:
TBI
SAH
ICP
non invasive measurement

Additional relevant MeSH terms:
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Subarachnoid Hemorrhage
Hemorrhage
Intracranial Hemorrhages
Brain Injuries
Brain Injuries, Traumatic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries
Pathologic Processes
Cerebrovascular Disorders
Vascular Diseases
Cardiovascular Diseases