Non Invasive Measurements of Intracranial Pressure After Aneurysmal Subarachnoid Hemorrhage
NCT ID: NCT03040284
Last Updated: 2017-02-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
140 participants
INTERVENTIONAL
2015-03-31
2018-03-31
Brief Summary
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A novel method for detecting changes in ICP has developed recently. The auditory hair cells emit sounds and electric signals in response to sound, which can be easily detected and measured non-invasively with the help of a microphone probe placed in the external ear canal or regular electrodes. Indeed, the cochlear aqueduct connects the cerebrospinal fluid (CSF) spaces to the inner ear in such a way that ICP and inner-ear fluid pressure equalize within seconds.
The evaluation of intracranial hypertension by increased ICP (invasive) is not systematically used after aneurysmal subarachnoid hemorrhage. It is then detected by using routine clinical signs of hydrocephalus or another disorder of cerebrospinal liquid flow, in combination with a standard imaging method (TDM).
The measurement of noninvasive ICP could allow earlier detection of hydrocephalus or another disorder of cerebrospinal liquid flow, and evaluate whether the increase in ICP precedes patient clinical worsening and / or imaging.
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Detailed Description
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A novel method for detecting changes in ICP has developed recently. The auditory hair cells emit sounds and electric signals in response to sound, which can be easily detected and measured non-invasively with the help of a microphone probe placed in the external ear canal or regular electrodes. Indeed, the cochlear aqueduct connects the cerebrospinal fluid (CSF) spaces to the inner ear in such a way that ICP and inner-ear fluid pressure equalize within seconds.
The evaluation of intracranial hypertension by increased ICP (invasive) is not systematically used after aneurysmal subarachnoid hemorrhage. It is then detected by using routine clinical signs of hydrocephalus or another disorder of cerebrospinal liquid flow, in combination with a standard imaging method (TDM).
The measurement of noninvasive ICP could allow earlier detection of hydrocephalus or another disorder of cerebrospinal liquid flow, and evaluate whether the increase in ICP precedes patient clinical worsening and / or imaging.
Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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aneurysmal subarachnoid hemorrhage
Echodia® hand-held equipment (ELIOS)
Interventions
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Echodia® hand-held equipment (ELIOS)
Eligibility Criteria
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Inclusion Criteria
* Valid tympanometry test at least for one ear
* Between 18 and 75 years of age
* Cochlear response useful at least for an ear which has validate the tympanometry test
* Written informed consent reviewed and signed by patient
* Affiliation to a social security scheme
Exclusion Criteria
* Collect of cochlear responses impossible for the ear or both ear which validate the tympanometry test
* Patient refusal after enlightened information
18 Years
75 Years
ALL
No
Sponsors
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University Hospital, Clermont-Ferrand
OTHER
Responsible Party
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Locations
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Chu Clermont-Ferrand
Clermont-Ferrand, , France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2014-A01300-47
Identifier Type: OTHER
Identifier Source: secondary_id
CHU-301
Identifier Type: -
Identifier Source: org_study_id
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