Non-invasive ONSD-based Neuromonitoring in a Neurointensive Care Setting (ONSDDynamics)

University Hospital Tuebingen

Status: Not yet enrolling

Conditions: Subarachnoid Hemorrhage; Intracranial Hypertension; Trauma, Brain

Treatments: Diagnostic Test: Sonographic determination of the optic nerve sheath diameter

Study type: Interventional

Funder types: Other

Identifiers

NCT05818371

ONSDTue

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 1 patient group

Pathologic and non-pathologic intracranial pressure

Other group

Description:

Sonographic determination of Optic nerve sheath. Parallel recording of ICP

Treatment:

Diagnostic Test: Sonographic determination of the optic nerve sheath diameter