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Non Invasive Measurements of Intracranial Pressure After Aneurysmal Subarachnoid Hemorrhage (HEMAPIC)

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: NCT03040284
Recruitment Status : Unknown
Verified January 2017 by University Hospital, Clermont-Ferrand.
Recruitment status was:  Recruiting
First Posted : February 2, 2017
Last Update Posted : February 2, 2017
Sponsor:
Information provided by (Responsible Party):
University Hospital, Clermont-Ferrand

Brief Summary:

In patients at risk of increased intracranial pressure (ICP), ICP measurements require invasive transducers, usually with insertion of a catheter into the cranium, or through a spinal tap. These invasive modalities involve risks and pain and they can be done only in specialized care units, with a high associated cost.

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.


Condition or disease Intervention/treatment Phase
Aneurysmal Subarachnoid Hemorrhage, Familial Device: Echodia® hand-held equipment (ELIOS) Not Applicable

Detailed Description:

In patients at risk of increased intracranial pressure (ICP), ICP measurements require invasive transducers, usually with insertion of a catheter into the cranium, or through a spinal tap. These invasive modalities involve risks and pain and they can be done only in specialized care units, with a high associated cost.

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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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Masking Description: open
Primary Purpose: Diagnostic
Official Title: Non Invasive Measurements of Intracranial Pressure After Aneurysmal Subarachnoid Hemorrhage
Actual Study Start Date : March 2015
Estimated Primary Completion Date : March 2018
Estimated Study Completion Date : March 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding

Arm Intervention/treatment
Experimental: aneurysmal subarachnoid hemorrhage Device: Echodia® hand-held equipment (ELIOS)



Primary Outcome Measures :
  1. Presence of an intracranial pressure variation or increase [ Time Frame: at day 1 ]
    Presence of an intracranial pressure variation or increase when physician has diagnosed a clinical or imaging disorder of the cerebrospinal liquid flow with standard diagnose methods (composite outcome measure): clinical signs, TDM and assessment of bifrontal index.


Secondary Outcome Measures :
  1. Evolution of ICP before and after the development of disorder of the cerebrospinal liquid flow according to clinical sign and/or TDM. [ Time Frame: at day 1 ]
  2. Efficiency of the measurement device on repetitive measurement during one year as evaluated by composite outcome measure: clinical signs, TDM. [ Time Frame: at day 1 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients which had recently (few days) aneurysmal subarachnoid hemorrhage
  • 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:

  • Invalid tympanometry test for the both ears
  • Collect of cochlear responses impossible for the ear or both ear which validate the tympanometry test
  • Patient refusal after enlightened information

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): NCT03040284


Contacts
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Contact: Patrick LACARIN 0473751195 placarin@chu-clermontferrand.fr

Locations
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France
Chu Clermont-Ferrand Recruiting
Clermont-Ferrand, France, 63003
Contact: Patrick LACARIN    04 73 75 11 95    placarin@chu-clermontferrand.fr   
Principal Investigator: Paul AVAN         
Sponsors and Collaborators
University Hospital, Clermont-Ferrand
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Responsible Party: University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT03040284    
Other Study ID Numbers: CHU-301
2014-A01300-47 ( Other Identifier: 2014-A01300-47 )
First Posted: February 2, 2017    Key Record Dates
Last Update Posted: February 2, 2017
Last Verified: January 2017

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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 University Hospital, Clermont-Ferrand:
noninvasive monitoring
intracranial pressure
cochlear electrophysiology
aneurysmal subarachnoid haemorrhage
cerebrovascular disorders
brain diseases
Additional relevant MeSH terms:
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Subarachnoid Hemorrhage
Hemorrhage
Pathologic Processes
Intracranial Hemorrhages
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases