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

NCT04849221 | Completed

• 1 other identifier: BOZORG NOURRISSON 2020
• Study Type: observational
• Target: 41
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

Patients

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

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

healthy subjects

No otologic or neurological history

Other: Collection of clinical and paraclinical data; Other: Intracranial pressure reading (ICP)

Interventions

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

Patients

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...

Patients; healthy subjects

Intracranial pressure reading (ICP) OTHER

a single measure

Patients; healthy subjects

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Patients:
• 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:
• Age \> 18 years old
• No otologic or neurological history.

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire Dijon: lead

Study Sites (1)

Chu Dijon Bourogne

Dijon, 21000, France

Location

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 13, 2021
• First Posted: April 19, 2021
• Study Start: March 4, 2021
• Primary Completion: August 22, 2021
• Study Completion: August 22, 2021
• Last Updated: February 24, 2023

Record last verified: 2023-02

Locations

FR (1)