Trauma, BrainONSDDynamicsNCT05818371
Non-invasive ONSD-based Neuromonitoring in a Neurointensive Care Setting
A study testing Sonographic determination of the optic nerve sheath diameter in people with Trauma, Brain and Subarachnoid Hemorrhage, run by University Hospital Tuebingen at 1 site in Germany.
Trial summary
Intensive care patients with established invasive intracranial neuromonitoring due to neurotrauma are subjected to a repeated non-invasive sonographic recording of the optic-nerve-sheath-diameter (ONSD). The recorded images are analyzed through a machine-learning-algorithm and an experienced ultrasound operator. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Trauma, Brain, Subarachnoid Hemorrhage, Intracranial Hypertension
- What is being tested?
- Sonographic determination of the optic nerve sheath diameter
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteGermany
- Study dates
- 1 May 2023to Mar 2024
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Traumatic or non-traumatic (e.g. SAH) brain injury
- Established invasive intracranial pressure monitoring (either intraparenchymal or Intraventricular)
Who cannot join
- Soft tissue damage to orbital or periorbital region
- Fracture of the Orbita
- Status post decompressive craniectomy
Trial locations and contacts
1 site in 1 country.
Germany1 site
University Hospital Tuebingen
Tübingen, Baden-Wurttemberg, 72076
Jonas Tellermann, MD, +4970712868685, Jonas.Tellermann@med.uni-tuebingen
About this study
Official title: Non-invasive Neuromonitoring Through Point-of-care Determination of ONSD and Assessment of Dynamic Properties of the Optic Nerve Sheath in a Neurointensive Care Setting
Intensive care patients with established invasive intracranial neuromonitoring due to neurotrauma are subjected to a repeated non-invasive sonographic recording of the optic-nerve-sheath-diameter (ONSD). The recorded images are analyzed through a machine-learning-algorithm and an experienced ultrasound operator. Results are correlated to the parallel recorded intracranial pressure (ICP). The study aims to establish ONSD as a supplementary for raised ICP.
Read the detailed description
During the intensive care stay, patients with implemented invasive intracranial pressure monitoring will have sonographic recording of the optic nerve sheath (video clip) with a parallel recording of the underlying ICP. The obtained image material is then i) analyzed by a machine-learning algorithm and ii) manually by 2 blinded differently experienced examiners (expert, novice) with respect to the ONSD. For the manual procedure, three individual measurements are made for each eye and the mean value is determined.
Subsequently, the measured values of the two examiners and the automated procedure are correlated with the ICP recorded during the sonographic examination.
- Being tested
- Sonographic determination of the optic nerve sheath diameter
- Medical subject headings
- Brain Injuries, Traumatic, Subarachnoid Hemorrhage, Intracranial Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sonographic determination of the optic nerve sheath diameterDiagnostic test
Ultrasound-based determination of the optic nerve sheath diameter
| Study group | Role | What they receive |
|---|---|---|
| Pathologic and non-pathologic intracranial pressure | Other | Sonographic determination of Optic nerve sheath. Parallel recording of ICP Receives: Diagnostic Test: Sonographic determination of the optic nerve sheath diameter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sonographic monitoring of optic nerve sheath
Repeated ultrasound-based measurement of optic nerve sheath in millimeter (mm)
Measured: Single measurement post-trauma up to day 10
Secondary outcomes (1)
Invasively measured intracranial pressure
Continuously recorded invasively (intra-parenchymal, intra-ventricular) determined intracranial pressure (mmHg)
Measured: Continuously from time of admission up to day 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2023
- Study start1 May 2023 (estimated)
- Primary completionDec 2023 (estimated)
- Study completionMar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Trauma, BrainStudies of the same condition, open and under way.
- More trials run by University Hospital TuebingenThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single center, prospective, open diagnostic study, proof-of-concept
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jonas Tellermann, MD, Principal investigator, University Hospital of Tuebingen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05818371
- Sponsor's protocol ID
- ONSDTue
- Acronym
- ONSDDynamics
- Status last verified
- Mar 2023
- First submitted
- 2 Mar 2023
- Last updated
- 18 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-invasive Neuromonitoring Through Point-of-care Determination of ONSD and Assessment of Dynamic Properties of the Optic Nerve Sheath in a Neurointensive Care Setting
- ClinicalTrials.gov ID
- NCT05818371
- Acronym / sponsor ID
- ONSDDynamics / ONSDTue
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Study start
- 1 May 2023 (estimated)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Mar 2024 (estimated)
- First posted
- 18 Apr 2023 (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.
Intensive care patients with established invasive intracranial neuromonitoring due to neurotrauma are subjected to a repeated non-invasive sonographic recording of the optic-nerve-sheath-diameter (ONSD). The recorded images are analyzed through a machine-learning-algorithm and an experienced ultrasound operator. Results are correlated to the parallel recorded intracranial pressure (ICP). The study aims to establish ONSD as a supplementary for raised ICP.
Detailed description
During the intensive care stay, patients with implemented invasive intracranial pressure monitoring will have sonographic recording of the optic nerve sheath (video clip) with a parallel recording of the underlying ICP. The obtained image material is then i) analyzed by a machine-learning algorithm and ii) manually by 2 blinded differently experienced examiners (expert, novice) with respect to the ONSD. For the manual procedure, three individual measurements are made for each eye and the mean value is determined.
Subsequently, the measured values of the two examiners and the automated procedure are correlated with the ICP recorded during the sonographic examination.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single center, prospective, open diagnostic study, proof-of-concept
| Arm | Type | Receives |
|---|---|---|
| Pathologic and non-pathologic intracranial pressure | Other | Diagnostic Test: Sonographic determination of the optic nerve sheath diameterSonographic determination of Optic nerve sheath. Parallel recording of ICP |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Traumatic or non-traumatic (e.g. SAH) brain injury
- Established invasive intracranial pressure monitoring (either intraparenchymal or Intraventricular)
Key exclusion criteria (3 listed)
- Soft tissue damage to orbital or periorbital region
- Fracture of the Orbita
- Status post decompressive craniectomy
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 |
|---|---|---|
| Sonographic determination of the optic nerve sheath diameterUltrasound-based determination of the optic nerve sheath diameter | Diagnostic test | Pathologic and non-pathologic intracranial pressure |
Primary outcome
Sonographic monitoring of optic nerve sheath
Time frame: Single measurement post-trauma up to day 10
Repeated ultrasound-based measurement of optic nerve sheath in millimeter (mm)
1 secondary outcome
Invasively measured intracranial pressure
Time frame: Continuously from time of admission up to day 10
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2023.
- Individual participant dataSharing planned: No
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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.
Jonas Tellermann, MD principal investigator
University Hospital of Tuebingen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sonographic determination of the optic nerve sheath diameter in people with Trauma, Brain and Subarachnoid Hemorrhage, run by University Hospital Tuebingen at 1 site in Germany.
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 2 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 18 Apr 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 Germany. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jonas Tellermann, MD (+4970712968685, Jonas.Tellermann@med.uni-tuebingen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sonographic monitoring of optic nerve sheath (time frame: Single measurement post-trauma up to day 10). 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 18 Apr 2023.