NCT05818371

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: University Hospital Tuebingen · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Trauma, Brain
• Subarachnoid Hemorrhage
• Intracranial Hypertension

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Sonographic determination of the optic nerve sheath diameter	Ultrasound-based determination of the optic nerve sheath diameter

Timeline

• Start date: 2023-05-01
• Primary completion: 2023-12-01
• Completion: 2024-03-01
• First posted: 2023-04-18
• Last updated: 2023-04-18

Locations

1 site across 1 country: Germany