Cranial Ultrasound for Prehospital ICH Diagnosis | NCT05492474

Studies
Cranial Ultrasound for Prehospital ICH Diagnosis

NCT05492474

Sponsor

Wake Forest University Health Sciences

Status

Completed

Last Update Posted

Sep 26, 2024Actual

Enrollment

81Actual

Phase

Not Applicable

Conditions

Intracerebral Hemorrhage
Acute Ischemic Stroke

Interventions

Cranial Point of Care Ultrasound

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

Sep 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

Sep 1, 2022Actual

Primary Completion Date

Apr 24, 2023Actual

Completion Date

Apr 24, 2023Actual

First Submitted Date

Aug 4, 2022

First Submission Date that Met QC Criteria

Aug 4, 2022

First Posted Date

Aug 8, 2022Actual

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

Sep 24, 2024

Last Update Posted Date

Sep 26, 2024Actual

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

FDAAA801 Violation

Not provided

Description Module

Brief Summary

To evaluate the feasibility of Emergency Medical System (EMS)-performed cPOCUS in the field for diagnosis of acute Intracerebral hemorrhage (ICH)

Detailed Description

With the over-arching goal of achieving early diagnosis of Intracerebral hemorrhage (ICH) with cPOCUS, this study hypothesizes that (a) Emergency Medical System (EMS) personnel can competently perform cPOCUS in the field in a timely fashion in a large majority of stroke patients; (b) acquired POCUS images can be successfully and securely transmitted for a remote physician interpretation in a timely manner; and (c) cPOCUS will have a greater sensitivity and specificity than clinical scores as a screening tool for ICH identification in pre-hospital settings.

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

81Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Cranial Point of Care Ultrasound	Experimental	Cranial ultrasound involves 2-dimensional B mode imaging of the brain parenchyma in the axial plane	Procedure: Cranial Point of Care Ultrasound

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Cranial Point of Care Ultrasound	Procedure	Cranial ultrasound involves 2-dimensional B mode imaging of the brain parenchyma in the axial plane using a 1-2 MHz probe through the thin temporal bone. Upload of cPOCUS images will occur over DICOM® based Health Insurance Portability and Accountability Act (HIPAA) compliant platforms accessible via Cloud. Currently all handheld machines use Tricefy® or their own cloud based remote image access application.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Success Rate for cPOCUS Exams	cPOCUS will be attempted and performed on about 1000 patients over 12 months by 30 EMS providers	Year 1

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Any patient deemed to have a stroke like presentation or possibility of brain hemorrhage in the clinical judgement of the Emergency Medical Services (EMS) provider and a decision to transfer the patient to the nearest Emergency Department (ED) for further evaluation has been made will be eligible for the study
18 years old or older
transfer initiated by EMS to the ED for further evaluation
performing ultrasound will not interfere with the care or triage as part of routine care

Exclusion Criteria:

less than 18 years old
incarcerate patients
penetrating cranial/head trauma or scalp wound
any patient where performing ultrasound will interfere with the care
patients who decide not to be transported to ED

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Aarti Sarwal, MD	Wake Forest University Health Sciences	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Wake Forest University Health Sciences		Winston-Salem	North Carolina	27157	United States

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Individual participant data that underlie the results reported in this article after deidentification (text, tables, figures, and appendices)

Types

Study Protocol
Statistical Analysis Plan (SAP)

Time Frame

Beginning 3 months and ending 5 years following article publication

Access Criteria

Researchers who provide a methodologically sound proposal

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	Nov 16, 2023	Sep 24, 2024	ICF_000.pdf

Condition Browse Module

MeSH Terms

ID	Term
D002543	Cerebral Hemorrhage
D000083242	Ischemic Stroke

Ancestor Terms

ID	Term
D020300	Intracranial Hemorrhages
D002561	Cerebrovascular Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Model Description

Any patient deemed to have a stroke like presentation or possibility of brain hemorrhage in the clinical judgement of the EMS provider and a decision to transfer the patient to the nearest ED for further evaluation has been made