Subarachnoid Hemorrhage Clinical Trial
— ONSDDynamicsOfficial 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
NCT number | NCT05818371 |
Other study ID # | ONSDTue |
Secondary ID | |
Status | Not yet recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | May 1, 2023 |
Est. completion date | March 2024 |
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.
Status | Not yet recruiting |
Enrollment | 60 |
Est. completion date | March 2024 |
Est. primary completion date | December 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
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 |
Country | Name | City | State |
---|---|---|---|
Germany | University Hospital Tuebingen | Tuebingen | Baden-Wuerttemberg |
Lead Sponsor | Collaborator |
---|---|
University Hospital Tuebingen |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Secondary | 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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