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)

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°.

Study Overview

• Status: Completed
• Conditions: Intracranial Pressure
• Intervention / Treatment: Other: Tympanometry measurement in both ears; Other: Collection of clinical and paraclinical data; Other: Intracranial pressure reading (ICP)

• Study Type: Observational
• Enrollment (Actual): 41

Contacts and Locations

Study Locations

• France
  • Dijon, France, 21000
    • Chu Dijon Bourogne

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients; Head trauma, patient operated on for an intracranial lesion, or other condition (hemorrhagic stroke)	Other: Tympanometry 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; Other: Collection 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...; Other: Intracranial pressure reading (ICP); a single measure
healthy subjects; No otologic or neurological history	Other: Collection 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...; Other: Intracranial pressure reading (ICP); a single measure

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire Dijon

Study record dates

Study Major Dates

• Study Start (Actual): March 4, 2021
• Primary Completion (Actual): August 22, 2021
• Study Completion (Actual): August 22, 2021

Study Registration Dates

• First Submitted: April 13, 2021
• First Submitted That Met QC Criteria: April 13, 2021
• First Posted (Actual): April 19, 2021

Study Record Updates

• Last Update Posted (Actual): February 24, 2023
• Last Update Submitted That Met QC Criteria: February 23, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Brain Injuries; Hemorrhage; Brain Injuries, Traumatic; Intracranial Hemorrhages
• Other Study ID Numbers: BOZORG NOURRISSON 2020

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No