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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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04849221
Acronym
TYMPIC
Enrollment
41
Registered
2021-04-19
Start date
2021-03-04
Completion date
2021-08-22
Last updated
2023-02-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intracranial Pressure

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°.

Interventions

OTHERTympanometry measurement in both ears

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

OTHERCollection of clinical and paraclinical data

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...

OTHERIntracranial pressure reading (ICP)

a single measure

Sponsors

Centre Hospitalier Universitaire Dijon
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
Width between conductance peaks of tympanometry at 2kHz as a function of intracranial pressureApproximately on the 10th day
Middle ear resonance frequency as a function of intracranial pressureApproximately on the 10th day
Volume of the ear canal as a function of intracranial pressureApproximately on the 10th day

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026