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OpenTrials
Completed

NCT Number: NCT04849221

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

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°.

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Key information

Conditions

Intracranial Pressure

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Chu Dijon Bourogne

Dijon, 21000, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tympanometry measurement in both ears

Other

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

Collection of clinical and paraclinical data

Other

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...

Intracranial pressure reading (ICP)

Other

a single measure

Primary outcomes

  1. Volume of the ear canal as a function of intracranial pressure

    Time frame: Approximately on the 10th day

  2. Width between conductance peaks of tympanometry at 2kHz as a function of intracranial pressure

    Time frame: Approximately on the 10th day

  3. Middle ear resonance frequency as a function of intracranial pressure

    Time frame: Approximately on the 10th day

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire Dijon

Other

Registry information

Acronym: TYMPIC

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Apr 19, 2021
Registry last updated
Feb 24, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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