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

April 17, 2023 updated by: University Hospital Tuebingen

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Germany
    • Baden-Wuerttemberg
      • Tuebingen, Baden-Wuerttemberg, Germany, 72076

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Pathologic and non-pathologic intracranial pressure
Sonographic determination of Optic nerve sheath. Parallel recording of ICP
Diagnostic test: Sonographic determination of the optic nerve sheath diameter
Ultrasound-based determination of the optic nerve sheath diameter

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Single measurement post-trauma up to day 10

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Invasively measured intracranial pressure
Time Frame: Continuously from time of admission up to day 10
Continuously recorded invasively (intra-parenchymal, intra-ventricular) determined intracranial pressure (mmHg)
Continuously from time of admission up to day 10

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Tuebingen

Investigators

  • Principal Investigator: Jonas Tellermann, MD, University Hospital Of Tuebingen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

May 1, 2023

Primary Completion (Anticipated)

December 1, 2023

Study Completion (Anticipated)

March 1, 2024

Study Registration Dates

First Submitted

March 2, 2023

First Submitted That Met QC Criteria

April 17, 2023

First Posted (Actual)

April 18, 2023

Study Record Updates

Last Update Posted (Actual)

April 18, 2023

Last Update Submitted That Met QC Criteria

April 17, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ONSDTue

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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