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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Enrollment
- 60
- Locations
- 2
- Primary Endpoint
- Sonographic monitoring of optic nerve sheath
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
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)
Secondary Outcomes
- Invasively measured intracranial pressure(Continuously from time of admission up to day 10)