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

• Sponsor: University Hospital Tuebingen (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05818371
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 10
• Patients Per Site Per Month: 6

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Trauma, Brain; Subarachnoid Hemorrhage; Intracranial Hypertension	Diagnostic Test: Sonographic determination of the optic nerve sheath diameter	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 60 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: Single center, prospective, open diagnostic study, proof-of-conceptSingle center, prospective, open diagnostic study, proof-of-concept
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• 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
• Anticipated Study Start Date: May 1, 2023
• Anticipated Primary Completion Date: Dec 1, 2023
• Anticipated Study Completion Date: Mar 1, 2024

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Sonographic monitoring of optic nerve sheath [Single measurement post-trauma up to day 10]

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

Secondary Outcome Measures

1. Invasively measured intracranial pressure [Continuously from time of admission up to day 10]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospital Tuebingen	Tuebingen	Baden-Wuerttemberg	Germany	72076

Sponsors and Collaborators

• University Hospital Tuebingen

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University Hospital Tuebingen
• ClinicalTrials.gov Identifier: NCT05818371
• Other Study ID Numbers: ONSDTue
• First Posted: Apr 18, 2023
• Last Update Posted: Apr 18, 2023
• Last Verified: Mar 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Subarachnoid Hemorrhage; Intracranial Hypertension; Brain Injuries, Traumatic; Hemorrhage

Study Results

No Results Posted as of Apr 18, 2023