In-Field Detection of Intracranial Pressure

In-Field Detection of Acute Intracranial Hemorrhage Requiring Urgent, Life-Saving Treatment in Severe Traumatic Brain Injury (TBI) Patients

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04515212

Enrollment

Registered

2020-08-17

Start date

2021-02-03

Completion date

2024-02-10

Last updated

2024-07-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Traumatic Brain Injury

Brief summary

This is a research study to develop a noninvasive test using ultrasound to determine when urgent, life-saving treatment is needed for those with severe traumatic brain injuries.

Interventions

OTHEROptic Nerve Ultrasounds

Patients will have up to four ultrasounds of the optic nerve.

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

SCREENING

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 99 Years

Healthy volunteers

Yes

Inclusion criteria

Healthy Volunteer Inclusion Criteria: * Adults 18 or older * Able to provide legally effective consent Healthy Volunteer

Exclusion criteria

* Intracranial disease, neurologic symptoms, or eye pathology Patient Inclusion Criteria: * Adults age 18 or older * Confirmed or suspected severe traumatic brain injury * Able to provide legally effective consent Patient

Design outcomes

Primary

Measure	Time frame	Description
Optic nerve sheath diameter	Approximately 10 minutes at the time of ultrasounds	Develop software that will automatically measure optic nerve sheath diameter by analyzing the radio frequency data from an ultrasound probe intervention from those that do not, we will measure the optic nerve sheath diameter manually in the cross-sectional images.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026