In-Field Detection of Intracranial Pressure

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.

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Key information

Conditions

Traumatic Brain Injury Brain Diseases Brain Injuries Brain Injuries, Traumatic Central Nervous System Diseases Craniocerebral Trauma Nervous System Diseases Trauma, Nervous System Wounds and Injuries

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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 Exclusion Criteria:

Significant bilateral ocular trauma

Treatment and study plan

Optic Nerve Ultrasounds

Other

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

Primary outcomes

Optic nerve sheath diameter

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

United States Department of Defense

Registry information

Official study title

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

Important dates

Study start: 2021
Primary completion: 2024
Study completion: 2024
First posted: Aug 17, 2020
Registry last updated: Jul 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed