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Clinical Trials/NCT05818371
NCT05818371
Not yet recruiting
Not Applicable

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

University Hospital Tuebingen1 site in 1 country60 target enrollmentMay 1, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Trauma, Brain
Sponsor
University Hospital Tuebingen
Enrollment
60
Locations
1
Primary Endpoint
Sonographic monitoring of optic nerve sheath
Status
Not yet recruiting
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 1, 2023
End Date
March 2024
Last Updated
3 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Sonographic monitoring of optic nerve sheath

Time Frame: Single measurement post-trauma up to day 10

Repeated ultrasound-based measurement of optic nerve sheath in millimeter (mm)

Secondary Outcomes

  • Invasively measured intracranial pressure(Continuously from time of admission up to day 10)

Study Sites (1)

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