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

NCT05818371 | Unknown

• 1 other identifier: ONSDTue
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Trauma, Brain; Subarachnoid Hemorrhage; Intracranial Hypertension

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Invasively measured intracranial pressure

  Continuously from time of admission up to day 10

Study Arms (1)

Pathologic and non-pathologic intracranial pressure

OTHER

Sonographic determination of Optic nerve sheath. Parallel recording of ICP

Diagnostic Test: Sonographic determination of the optic nerve sheath diameter

Interventions

Sonographic determination of the optic nerve sheath diameter DIAGNOSTIC_TEST

Ultrasound-based determination of the optic nerve sheath diameter

Pathologic and non-pathologic intracranial pressure

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Traumatic or non-traumatic (e.g. SAH) brain injury
• Established invasive intracranial pressure monitoring (either intraparenchymal or Intraventricular)

You may not qualify if:

• Soft tissue damage to orbital or periorbital region
• Fracture of the Orbita
• Status post decompressive craniectomy

Sponsors & Collaborators

• University Hospital Tuebingen: lead

Study Sites (1)

University Hospital Tuebingen

Tübingen, Baden-Wurttemberg, 72076, Germany

Location

MeSH Terms

Conditions

Brain Injuries, Traumatic; Subarachnoid Hemorrhage; Intracranial Hypertension

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Intracranial Hemorrhages; Cerebrovascular Disorders; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jonas Tellermann, MD

  University Hospital of Tuebingen

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jonas Tellermann, MD

CONTACT

+4970712968685; Jonas.Tellermann@med.uni-tuebingen.de

Martin U Schuhmann, Prof

CONTACT

+4907071290; Martin.Schuhmann@med.uni-tuebingen.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single center, prospective, open diagnostic study, proof-of-concept

Study Record Dates

• First Submitted: March 2, 2023
• First Posted: April 18, 2023
• Study Start: May 1, 2023
• Primary Completion: December 1, 2023
• Study Completion: March 1, 2024
• Last Updated: April 18, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)