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

Completed

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

• Registration Number: NCT04849221
• Lead Sponsor: Centre Hospitalier Universitaire Dijon

Brief Summary

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°.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-03-04
• Study First Submitted: 2021-04-13
• Study First Submitted QC: 2021-04-13
• Study First Posted: 2021-04-19
• Primary Completion: 2021-08-22
• Study Completion: 2021-08-22
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-23
• Last Update Posted: 2023-02-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 41

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
healthy subjects	Intracranial pressure reading (ICP)	No otologic or neurological history
Patients	Tympanometry measurement in both ears	Head trauma, patient operated on for an intracranial lesion, or other condition (hemorrhagic stroke)
healthy subjects	Collection of clinical and paraclinical data	No otologic or neurological history
Patients	Collection of clinical and paraclinical data	Head trauma, patient operated on for an intracranial lesion, or other condition (hemorrhagic stroke)
Patients	Intracranial pressure reading (ICP)	Head trauma, patient operated on for an intracranial lesion, or other condition (hemorrhagic stroke)

Primary Outcome Measures

Name	Time	Method
Volume of the ear canal 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
Width between conductance peaks of tympanometry at 2kHz as a function of intracranial pressure	Approximately on the 10th day

Trial Locations

Locations (1)

Chu Dijon Bourogne; 🇫🇷 Dijon, France