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 (TYMPIC)

University Hospital Center (CHU) Dijon Bourgogne

Status: Completed

Conditions: Intracranial Pressure

Treatments: Other: Tympanometry measurement in both ears; Other: Intracranial pressure reading (ICP); Other: Collection of clinical and paraclinical data

Study type: Observational

Funder types: Other

Identifiers

NCT04849221

BOZORG NOURRISSON 2020

Details and patient eligibility

About

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°.

Enrollment: 41 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

41 participants in 2 patient groups

Patients

Description:

Head trauma, patient operated on for an intracranial lesion, or other condition (hemorrhagic stroke)

Treatment:

Other: Collection of clinical and paraclinical data

Other: Tympanometry measurement in both ears

Other: Intracranial pressure reading (ICP)

healthy subjects

Description:

No otologic or neurological history

Treatment:

Other: Collection of clinical and paraclinical data

Other: Intracranial pressure reading (ICP)