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

Primary Purpose

Aneurysmal Subarachnoid Hemorrhage, Familial

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Echodia® hand-held equipment (ELIOS)
Sponsored by
University Hospital, Clermont-Ferrand
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Aneurysmal Subarachnoid Hemorrhage, Familial focused on measuring noninvasive monitoring, intracranial pressure, cochlear electrophysiology, aneurysmal subarachnoid haemorrhage, cerebrovascular disorders, brain diseases

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Chu Clermont-FerrandRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

aneurysmal subarachnoid hemorrhage

Arm Description

Outcomes

Primary Outcome Measures

Presence of an intracranial pressure variation or increase
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

Evolution of ICP before and after the development of disorder of the cerebrospinal liquid flow according to clinical sign and/or TDM.
Efficiency of the measurement device on repetitive measurement during one year as evaluated by composite outcome measure: clinical signs, TDM.

Full Information

First Posted
January 26, 2017
Last Updated
January 31, 2017
Sponsor
University Hospital, Clermont-Ferrand
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1. Study Identification

Unique Protocol Identification Number
NCT03040284
Brief Title
Non Invasive Measurements of Intracranial Pressure After Aneurysmal Subarachnoid Hemorrhage
Acronym
HEMAPIC
Official Title
Non Invasive Measurements of Intracranial Pressure After Aneurysmal Subarachnoid Hemorrhage
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Unknown status
Study Start Date
March 2015 (Actual)
Primary Completion Date
March 2018 (Anticipated)
Study Completion Date
March 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Clermont-Ferrand

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aneurysmal Subarachnoid Hemorrhage, Familial
Keywords
noninvasive monitoring, intracranial pressure, cochlear electrophysiology, aneurysmal subarachnoid haemorrhage, cerebrovascular disorders, brain diseases

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Masking Description
open
Allocation
N/A
Enrollment
140 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
aneurysmal subarachnoid hemorrhage
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Echodia® hand-held equipment (ELIOS)
Primary Outcome Measure Information:
Title
Presence of an intracranial pressure variation or increase
Description
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.
Time Frame
at day 1
Secondary Outcome Measure Information:
Title
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
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Patrick LACARIN
Phone
0473751195
Email
placarin@chu-clermontferrand.fr
Facility Information:
Facility Name
Chu Clermont-Ferrand
City
Clermont-Ferrand
ZIP/Postal Code
63003
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patrick LACARIN
Phone
04 73 75 11 95
Email
placarin@chu-clermontferrand.fr
First Name & Middle Initial & Last Name & Degree
Paul AVAN

12. IPD Sharing Statement

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Non Invasive Measurements of Intracranial Pressure After Aneurysmal Subarachnoid Hemorrhage

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