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

Not Applicable

Not yet recruiting

• Conditions: Subarachnoid Hemorrhage; Intracranial Hypertension; Trauma, Brain
• Interventions: Diagnostic Test: Sonographic determination of the optic nerve sheath diameter

• Registration Number: NCT05818371
• Lead Sponsor: University Hospital Tuebingen

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 Timeline

• Status Verified: 2023-03
• Study First Submitted: 2023-03-02
• Study First Submitted QC: 2023-04-17
• Last Update Submitted: 2023-04-17
• Study First Posted: 2023-04-18
• Last Update Posted: 2023-04-18
• Study Start: 2023-05-01
• Primary Completion: 2023-12
• Study Completion: 2024-03

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Pathologic and non-pathologic intracranial pressure	Sonographic determination of the optic nerve sheath diameter	Sonographic determination of Optic nerve sheath. Parallel recording of ICP

Primary Outcome Measures

Name	Time	Method
Sonographic monitoring of optic nerve sheath	Single measurement post-trauma up to day 10	Repeated ultrasound-based measurement of optic nerve sheath in millimeter (mm)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University Hospital Tuebingen; 🇩🇪 Tuebingen, Baden-Wuerttemberg, Germany