Aneurysmal Subarachnoid Hemorrhage, Familial Clinical Trial
— HEMAPICOfficial title:
Non Invasive Measurements of Intracranial Pressure After Aneurysmal Subarachnoid Hemorrhage
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.
| Status | Recruiting |
| Enrollment | 140 |
| Est. completion date | March 2018 |
| Est. primary completion date | March 2018 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 75 Years |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| France | Chu Clermont-Ferrand | Clermont-Ferrand |
| Lead Sponsor | Collaborator |
|---|---|
| University Hospital, Clermont-Ferrand |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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. | at day 1 | |
| Secondary | Evolution of ICP before and after the development of disorder of the cerebrospinal liquid flow according to clinical sign and/or TDM. | at day 1 | ||
| Secondary | Efficiency of the measurement device on repetitive measurement during one year as evaluated by composite outcome measure: clinical signs, TDM. | at day 1 |