Wideband Tympanometry for Monitoring Intracranial Pressure in Adult Patients in Intensive Care, Operated on for an Intracranial Lesion After Traumatic Brain Injury, or With Intracranial Hemorrhage

Study Overview
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Brief Summary
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Intracranial pressure is usually measured by invasive methods requiring an intracranial sensor. There is no non-invasive monitoring method recognized as a gold standard. Tympanometry would make it feasible to evaluate intracranial pressure through sensitive and specific changes in the energy absorbance of the middle ear. It could represent a non-invasive method of monitoring intracranial pressure. This is a prospective monocentric longitudinal study. All adult patients in intensive care for head trauma, intracranial hypertension, or after cranial surgery and requiring invasive monitoring of ICP will be included after their non-opposition has been collected. In a group of 10 controls, multifrequency tympanometry will be performed in the standing position, in the 0° supine position and in the Tredelenburg position at -17°.

Official Title
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Wideband Tympanometry for Monitoring Intracranial Pressure in Adult Patients in Intensive Care, Operated on for an Intracranial Lesion After Traumatic Brain Injury, or With Intracranial Hemorrhage

Conditions
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Intracranial Pressure

Intervention / Treatment
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* Other: Tympanometry measurement in both ears
* Other: Collection of clinical and paraclinical data
* Other: Intracranial pressure reading (ICP)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients: Person who did not oppose to their inclusion in the trial Head trauma, patient operated on for an intracranial lesion, or other condition (hemorrhagic stroke...) requiring monitoring of ICP by a subdural or epidural sensor. Age > 18 years old Controls: Person who did not oppose to their inclusion in the trial Age > 18 years old No otologic or neurological history. Exclusion Criteria: Person subject to a measure of legal protection (curatorship, guardianship) Person under judicial control Pregnant, parturient or breastfeeding woman Minor Fracture of the petrosal bone, abnormality of the bilateral middle or inner ear or canal preventing tympanometry

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients<br>Head trauma, patient operated on for an intracranial lesion, or other condition (hemorrhagic stroke) | Other: Tympanometry measurement in both ears<br>* Measurement once or twice a day and at every change of more than 10 mmHg in ICP, over the entire period of time that ICP is measured by a probe or DVE<br>Other: Collection of clinical and paraclinical data<br>* Patient: gender, weight/height, age, etiology of ICP entry, reason for ICP monitoring, presence of external (otoscopy), middle (otoscopy + CT) or internal (CT) ear abnormality, presence of inclusion and non-inclusion criteria, measurement of patient tilt. healthy subjects: gender, weight/height, age, presence of abnormality of the external (otoscopy), middle (otoscopy) or internal ear (questioning), presence of inclusion and non-inclusion criteria...<br>Other: Intracranial pressure reading (ICP)<br>* a single measure<br>|
| healthy subjects<br>No otologic or neurological history | Other: Collection of clinical and paraclinical data<br>* Patient: gender, weight/height, age, etiology of ICP entry, reason for ICP monitoring, presence of external (otoscopy), middle (otoscopy + CT) or internal (CT) ear abnormality, presence of inclusion and non-inclusion criteria, measurement of patient tilt. healthy subjects: gender, weight/height, age, presence of abnormality of the external (otoscopy), middle (otoscopy) or internal ear (questioning), presence of inclusion and non-inclusion criteria...<br>Other: Intracranial pressure reading (ICP)<br>* a single measure<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Volume of the ear canal as a function of intracranial pressure |  | Approximately on the 10th day | 
| Width between conductance peaks of tympanometry at 2kHz as a function of intracranial pressure |  | Approximately on the 10th day | 
| Middle ear resonance frequency as a function of intracranial pressure |  | Approximately on the 10th day |