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Clinical Trials/NCT04849221
NCT04849221CompletedNot Applicable

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

Centre Hospitalier Universitaire Dijon1 site in 1 country41 target enrollmentStarted: March 4, 2021Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
41
Locations
1
Primary Endpoint
Volume of the ear canal as a function of intracranial pressure

Study Overview

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°.

Study Design

Study Type
Observational
Observational Model
Case Control
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • 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
  • 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
  • Fracture of the petrosal bone, abnormality of the bilateral middle or inner ear or canal preventing tympanometry

Outcomes

Primary Outcomes

Volume of the ear canal as a function of intracranial pressure

Time Frame: Approximately on the 10th day

Middle ear resonance frequency as a function of intracranial pressure

Time Frame: Approximately on the 10th day

Width between conductance peaks of tympanometry at 2kHz as a function of intracranial pressure

Time Frame: Approximately on the 10th day

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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