In-Field Detection of Intracranial Pressure

NCT ID: NCT04515212

Last Updated: 2024-07-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

53 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-03

Study Completion Date

2024-02-10

Brief Summary

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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.

Detailed Description

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Conditions

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Traumatic Brain Injury

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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Healthy Volunteers

Group Type ACTIVE_COMPARATOR

Optic Nerve Ultrasounds

Intervention Type OTHER

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

Traumatic Brain Injury Patients

Group Type EXPERIMENTAL

Optic Nerve Ultrasounds

Intervention Type OTHER

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

Interventions

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Optic Nerve Ultrasounds

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Adults 18 or older
* Able to provide legally effective consent


* Adults age 18 or older
* Confirmed or suspected severe traumatic brain injury
* Able to provide legally effective consent

Exclusion Criteria

* Intracranial disease, neurologic symptoms, or eye pathology


* Significant bilateral ocular trauma
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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United States Department of Defense

FED

Sponsor Role collaborator

Duke University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sean Montgomery

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

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Duke University Medical Center

Durham, North Carolina, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Informed Consent Form

View Document

Other Identifiers

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Pro00104100

Identifier Type: -

Identifier Source: org_study_id

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