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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pathologic and non-pathologic intracranial pressure | Other | Sonographic determination of Optic nerve sheath. Parallel recording of ICP |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sonographic determination of the optic nerve sheath diameter | Diagnostic Test | Ultrasound-based determination of the optic nerve sheath diameter |
|
| Measure | Description | Time Frame |
|---|---|---|
| Sonographic monitoring of optic nerve sheath | Repeated ultrasound-based measurement of optic nerve sheath in millimeter (mm) | Single measurement post-trauma up to day 10 |
| Measure | Description | Time Frame |
|---|---|---|
| Invasively measured intracranial pressure | Continuously recorded invasively (intra-parenchymal, intra-ventricular) determined intracranial pressure (mmHg) | Continuously from time of admission up to day 10 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jonas Tellermann, MD | Contact | +4970712968685 | Jonas.Tellermann@med.uni-tuebingen.de | |
| Martin U Schuhmann, Prof | Contact | +4907071290 | Martin.Schuhmann@med.uni-tuebingen.de |
| Name | Affiliation | Role |
|---|---|---|
| Jonas Tellermann, MD | University Hospital of Tuebingen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Tuebingen | Tübingen | Baden-Wurttemberg | 72076 | Germany |
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| ID | Term |
|---|---|
| D000070642 | Brain Injuries, Traumatic |
| D013345 | Subarachnoid Hemorrhage |
| D019586 | Intracranial Hypertension |
| ID | Term |
|---|---|
| D001930 | Brain Injuries |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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Single center, prospective, open diagnostic study, proof-of-concept
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| D006259 |
| Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
| D020300 | Intracranial Hemorrhages |
| D002561 | Cerebrovascular Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |