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

NCT ID: NCT04849221

Last Updated: 2023-02-24

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 41 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-03-04
• Study Completion Date: 2021-08-22

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°.

Conditions

Intracranial Pressure

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Patients

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

Tympanometry measurement in both ears

Intervention Type: 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

Intervention Type: 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)

Intervention Type: OTHER

a single measure

healthy subjects

No otologic or neurological history

Collection of clinical and paraclinical data

Intervention Type: 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)

Intervention Type: OTHER

a single measure

Interventions

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

Intervention Type: 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...

Intervention Type: OTHER

Intracranial pressure reading (ICP)

a single measure

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Centre Hospitalier Universitaire Dijon

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Chu Dijon Bourogne

Dijon, , France

Countries

France

Other Identifiers

BOZORG NOURRISSON 2020

Identifier Type: -

Identifier Source: org_study_id