In-Field Detection of Intracranial Pressure | NCT04515212

Studies
In-Field Detection of Intracranial Pressure

NCT04515212

Sponsor

Duke University

Status

Completed

Last Update Posted

Jul 22, 2024Actual

Enrollment

53Actual

Phase

Not Applicable

Conditions

Traumatic Brain Injury

Interventions

Optic Nerve Ultrasounds

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Document Has No Statistical Analysis Plan (SAP)

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 3, 2021Actual

Primary Completion Date

Feb 7, 2024Actual

Completion Date

Feb 10, 2024Actual

First Submitted Date

Aug 13, 2020

First Submission Date that Met QC Criteria

Aug 13, 2020

First Posted Date

Aug 17, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 18, 2024

Last Update Posted Date

Jul 22, 2024Actual

Name	Class
United States Department of Defense	FED

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

53Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Healthy Volunteers	Active Comparator		Other: Optic Nerve Ultrasounds
Traumatic Brain Injury Patients	Experimental		Other: Optic Nerve Ultrasounds

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Optic Nerve Ultrasounds	Other	Patients will have up to four ultrasounds of the optic nerve.	Healthy Volunteers Traumatic Brain Injury Patients

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Optic nerve sheath diameter	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.	Approximately 10 minutes at the time of ultrasounds

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

99 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Sean Montgomery	Duke University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Duke University Medical Center		Durham	North Carolina	27710	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
ICF	No	No	Yes	Informed Consent Form	Feb 1, 2023	Jul 18, 2024	ICF_000.pdf

Condition Browse Module

MeSH Terms

ID	Term
D000070642	Brain Injuries, Traumatic

Ancestor Terms

ID	Term
D001930	Brain Injuries
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided