Intracranial PressureTYMPICNCT04849221
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
An observational study of Intracranial Pressure, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Intracranial Pressure
- What is being tested?
- Tympanometry measurement in both ears, Collection of clinical and paraclinical data and Intracranial pressure reading (ICP)
- How many people
- 41 participants
- Where
- 1 siteFrance
- Study dates
- 4 Mar 2021to 22 Aug 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Head trauma patient operated on for an intracranial lesion or other condition (hemorrhagic stroke)
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Tympanometry measurement in both ears, Collection of clinical and paraclinical data, Intracranial pressure reading (ICP)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tympanometry measurement in both earsOther
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 dataOther
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)Other
a single measure
| Study group | Role | What they receive |
|---|---|---|
| Patients | Head trauma, patient operated on for an intracranial lesion, or other condition (hemorrhagic stroke) Receives: 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 Receives: Other: Collection of clinical and paraclinical data; Other: Intracranial pressure reading (ICP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Volume of the ear canal as a function of intracranial pressure
Measured: Approximately on the 10th day
Width between conductance peaks of tympanometry at 2kHz as a function of intracranial pressure
Measured: Approximately on the 10th day
Middle ear resonance frequency as a function of intracranial pressure
Measured: Approximately on the 10th day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2021
- Study start4 Mar 2021
- Primary completion22 Aug 2021
- Study completion22 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intracranial PressureStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire DijonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04849221
- Sponsor's protocol ID
- BOZORG NOURRISSON 2020
- Acronym
- TYMPIC
- Status last verified
- Feb 2023
- First submitted
- 13 Apr 2021
- Last updated
- 24 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04849221
- Acronym / sponsor ID
- TYMPIC / BOZORG NOURRISSON 2020
- Conditions
- Intracranial Pressure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- 4 Mar 2021 (actual)
- Primary completion
- 22 Aug 2021 (actual)
- Study completion
- 22 Aug 2021 (actual)
- First posted
- 19 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients | – | Other: Tympanometry measurement in both ears, Other: Collection of clinical and paraclinical data, Other: Intracranial pressure reading (ICP)Head trauma, patient operated on for an intracranial lesion, or other condition (hemorrhagic stroke) |
| healthy subjects | – | Other: Collection of clinical and paraclinical data, Other: Intracranial pressure reading (ICP)No otologic or neurological history |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Head trauma patient operated on for an intracranial lesion or other condition (hemorrhagic stroke)
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tympanometry measurement in both earsMeasurement 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 | Patients |
| Collection of clinical and paraclinical dataPatient: 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 | Patients, healthy subjects |
| Intracranial pressure reading (ICP)a single measure | Other | Patients, healthy subjects |
Primary outcome
Volume of the ear canal 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
Middle ear resonance frequency as a function of intracranial pressure
Time frame: Approximately on the 10th day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intracranial Pressure, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Volume of the ear canal as a function of intracranial pressure (time frame: Approximately on the 10th day). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2023.