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

University Hospital, Clermont-Ferrand

Status: Unknown

Conditions: Aneurysmal Subarachnoid Hemorrhage, Familial

Treatments: Device: Echodia® hand-held equipment (ELIOS)

Study type: Interventional

Funder types: Other

Identifiers

NCT03040284

CHU-301

2014-A01300-47 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 140 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No 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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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140 participants in 1 patient group

aneurysmal subarachnoid hemorrhage

Experimental group

Treatment:

Device: Echodia® hand-held equipment (ELIOS)