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 Clinical Trial

— TYMPIC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04849221
• Other study ID #: BOZORG NOURRISSON 2020
• Status: Completed
• Start date: March 4, 2021
• Est. completion date: August 22, 2021

Study information

• Verified date: February 2023
• Source: Centre Hospitalier Universitaire Dijon
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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°.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: August 22, 2021
• Est. primary completion date: August 22, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic
• Hemorrhage
• Intracranial Hemorrhages
• Intracranial Pressure

Intervention

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
• 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...
• Intracranial pressure reading (ICP)
a single measure

Locations

Country	Name	City	State
France	Chu Dijon Bourogne	Dijon

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire Dijon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Volume of the ear canal as a function of intracranial pressure		Approximately on the 10th day
Primary	Width between conductance peaks of tympanometry at 2kHz as a function of intracranial pressure		Approximately on the 10th day
Primary	Middle ear resonance frequency as a function of intracranial pressure		Approximately on the 10th day