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

Primary Purpose

Trauma, Brain, Subarachnoid Hemorrhage, Intracranial Hypertension

Status
Not yet recruiting
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Sonographic determination of the optic nerve sheath diameter
Sponsored by
University Hospital Tuebingen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Trauma, Brain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • University Hospital Tuebingen

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Pathologic and non-pathologic intracranial pressure

Arm Description

Sonographic determination of Optic nerve sheath. Parallel recording of ICP

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Invasively measured intracranial pressure
Continuously recorded invasively (intra-parenchymal, intra-ventricular) determined intracranial pressure (mmHg)

Full Information

First Posted
March 2, 2023
Last Updated
April 17, 2023
Sponsor
University Hospital Tuebingen
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1. Study Identification

Unique Protocol Identification Number
NCT05818371
Brief Title
Non-invasive ONSD-based Neuromonitoring in a Neurointensive Care Setting
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
May 1, 2023 (Anticipated)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
March 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital Tuebingen

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Trauma, Brain, Subarachnoid Hemorrhage, Intracranial Hypertension

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Single center, prospective, open diagnostic study, proof-of-concept
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Pathologic and non-pathologic intracranial pressure
Arm Type
Other
Arm Description
Sonographic determination of Optic nerve sheath. Parallel recording of ICP
Intervention Type
Diagnostic Test
Intervention Name(s)
Sonographic determination of the optic nerve sheath diameter
Intervention Description
Ultrasound-based determination of the optic nerve sheath diameter
Primary Outcome Measure Information:
Title
Sonographic monitoring of optic nerve sheath
Description
Repeated ultrasound-based measurement of optic nerve sheath in millimeter (mm)
Time Frame
Single measurement post-trauma up to day 10
Secondary Outcome Measure Information:
Title
Invasively measured intracranial pressure
Description
Continuously recorded invasively (intra-parenchymal, intra-ventricular) determined intracranial pressure (mmHg)
Time Frame
Continuously from time of admission up to day 10

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jonas Tellermann, MD
Phone
+4970712968685
Email
Jonas.Tellermann@med.uni-tuebingen.de
First Name & Middle Initial & Last Name or Official Title & Degree
Martin U Schuhmann, Prof
Phone
+4907071290
Email
Martin.Schuhmann@med.uni-tuebingen.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jonas Tellermann, MD
Organizational Affiliation
University Hospital of Tuebingen
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Tuebingen
City
Tuebingen
State/Province
Baden-Wuerttemberg
ZIP/Postal Code
72076
Country
Germany
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jonas Tellermann, MD
Phone
+4970712868685
Email
Jonas.Tellermann@med.uni-tuebingen

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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