In-Field Detection of Intracranial Pressure

Duke University

Status: Completed

Conditions: Traumatic Brain Injury

Treatments: Other: Optic Nerve Ultrasounds

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT04515212

Pro00104100

Details and patient eligibility

About

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.

Enrollment: 53 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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 Exclusion Criteria:

• Significant bilateral ocular trauma

Trial design

Primary purpose: Screening

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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53 participants in 2 patient groups

Healthy Volunteers

Active Comparator group

Treatment:

Other: Optic Nerve Ultrasounds

Traumatic Brain Injury Patients

Experimental group

Treatment:

Other: Optic Nerve Ultrasounds