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Non-invasive ONSD-based Neuromonitoring in a Neurointensive Care Setting

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05818371
Acronym
ONSDDynamics
Enrollment
60
Registered
2023-04-18
Start date
2023-05-01
Completion date
2024-03-31
Last updated
2023-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intracranial Hypertension, Subarachnoid Hemorrhage, Trauma, Brain

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

DIAGNOSTIC_TESTSonographic determination of the optic nerve sheath diameter

Ultrasound-based determination of the optic nerve sheath diameter

Sponsors

University Hospital Tuebingen
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Intervention model description

Single center, prospective, open diagnostic study, proof-of-concept

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
Sonographic monitoring of optic nerve sheathSingle measurement post-trauma up to day 10Repeated ultrasound-based measurement of optic nerve sheath in millimeter (mm)

Secondary

MeasureTime frameDescription
Invasively measured intracranial pressureContinuously from time of admission up to day 10Continuously recorded invasively (intra-parenchymal, intra-ventricular) determined intracranial pressure (mmHg)

Countries

Germany

Contacts

Primary ContactJonas Tellermann, MD
Jonas.Tellermann@med.uni-tuebingen.de+4970712968685
Backup ContactMartin U Schuhmann, Prof
Martin.Schuhmann@med.uni-tuebingen.de+4907071290

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026