Status:
COMPLETED
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
Lead Sponsor:
Centre Hospitalier Universitaire Dijon
Conditions:
Intracranial Pressure
Eligibility:
All Genders
18+ years
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 fea...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 4 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 22 2021
Estimated Enrollment :
41 Patients enrolled
Trial Details
Trial ID
NCT04849221
Start Date
March 4 2021
End Date
August 22 2021
Last Update
February 24 2023
Active Locations (1)
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1
Chu Dijon Bourogne
Dijon, France, 21000