Intracranial Hypertension, Subarachnoid Hemorrhage, Trauma, Brain
Conditions
Brief 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. 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.
Interventions
Ultrasound-based determination of the optic nerve sheath diameter
Sponsors
Study design
Intervention model description
Single center, prospective, open diagnostic study, proof-of-concept
Eligibility
Inclusion criteria
* Traumatic or non-traumatic (e.g. SAH) brain injury * Established invasive intracranial pressure monitoring (either intraparenchymal or Intraventricular)
Exclusion criteria
* Soft tissue damage to orbital or periorbital region * Fracture of the Orbita * Status post decompressive craniectomy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sonographic monitoring of optic nerve sheath | Single measurement post-trauma up to day 10 | Repeated ultrasound-based measurement of optic nerve sheath in millimeter (mm) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Invasively measured intracranial pressure | Continuously from time of admission up to day 10 | Continuously recorded invasively (intra-parenchymal, intra-ventricular) determined intracranial pressure (mmHg) |
Countries
Germany