TYMPIC: 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
Study Details
Study Description
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°.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | 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
|
Outcome Measures
Primary Outcome Measures
- 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]
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Chu Dijon Bourogne | Dijon | France | 21000 |
Sponsors and Collaborators
- Centre Hospitalier Universitaire Dijon
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- BOZORG NOURRISSON 2020