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

Subarachnoid Hemorrhage Clinical Trial

— ONSDDynamics  

Official 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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05818371
• Other study ID #: ONSDTue
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 1, 2023
• Est. completion date: March 2024

Study information

• Verified date: March 2023
• Source: University Hospital Tuebingen
• Contact: Jonas Tellermann, MD
• Phone: +4970712968685
• Email: Jonas.Tellermann[@]med.uni-tuebingen.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Brain Injuries, Traumatic
• Hemorrhage
• Intracranial Hypertension
• Subarachnoid Hemorrhage
• Trauma, Brain

Intervention

Diagnostic Test:
• Sonographic determination of the optic nerve sheath diameter
Ultrasound-based determination of the optic nerve sheath diameter

Locations

Country	Name	City	State
Germany	University Hospital Tuebingen	Tuebingen	Baden-Wuerttemberg

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Tuebingen

Country where clinical trial is conducted

Germany, 

Outcome

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