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Cranial Ultrasound for Prehospital ICH Diagnosis (CUPID_EMS)

Primary Purpose

Intracerebral Hemorrhage, Acute Ischemic Stroke

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Cranial Point of Care Ultrasound

About this trial

This is an interventional screening trial for Intracerebral Hemorrhage focused on measuring computed tomography (CT) scan

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Wake Forest University Health SciencesRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Cranial Point of Care Ultrasound

Arm Description

Cranial ultrasound involves 2-dimensional B mode imaging of the brain parenchyma in the axial plane

Outcomes

Primary Outcome Measures

Success Rate for cPOCUS Exams

cPOCUS will be attempted and performed on about 1000 patients over 12 months by 30 EMS providers

Secondary Outcome Measures

Full Information

NCT ID

NCT05492474

First Posted

August 4, 2022

Last Updated

August 10, 2023

Sponsor

Wake Forest University Health Sciences

1. Study Identification

Unique Protocol Identification Number

NCT05492474

Brief Title

Cranial Ultrasound for Prehospital ICH Diagnosis

Acronym

CUPID_EMS

Official Title

Cranial Ultrasound for Prehospital ICH Diagnosis (CUPID_EMS)

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Recruiting

Study Start Date

September 1, 2022 (Actual)

Primary Completion Date

June 2024 (Anticipated)

Study Completion Date

July 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Wake Forest University Health Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Intracerebral Hemorrhage, Acute Ischemic Stroke

Keywords

computed tomography (CT) scan

7. Study Design

Primary Purpose

Screening

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

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

Masking

None (Open Label)

Allocation

N/A

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Cranial Point of Care Ultrasound

Arm Type

Experimental

Arm Description

Cranial ultrasound involves 2-dimensional B mode imaging of the brain parenchyma in the axial plane

Intervention Type

Procedure

Intervention Name(s)

Cranial Point of Care Ultrasound

Intervention Description

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.

Primary Outcome Measure Information:

Title

Success Rate for cPOCUS Exams

Description

cPOCUS will be attempted and performed on about 1000 patients over 12 months by 30 EMS providers

Time Frame

Year 1

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Sahil Kapoor

Phone

336.716.2357

skapoor@wakehealth.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Cara Everhart

Phone

336-716-5371

ceverhar@wakehealth.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Aarti Sarwal, MD

Organizational Affiliation

Wake Forest University Health Sciences

Official's Role

Principal Investigator

Facility Information:

Facility Name

Wake Forest University Health Sciences

City

Winston-Salem

State/Province

North Carolina

ZIP/Postal Code

27157

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Sahil Kapoor

Phone

336-716-2357

skapoor@wakehealth.edu

First Name & Middle Initial & Last Name & Degree

Cara Everhart

Phone

336-716-5371

ceverhar@wakehealth.edu

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

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

IPD Sharing Time Frame

Beginning 3 months and ending 5 years following article publication

IPD Sharing Access Criteria

Researchers who provide a methodologically sound proposal

Learn more about this trial

Cranial Ultrasound for Prehospital ICH Diagnosis

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