Cranial Ultrasound for Prehospital ICH Diagnosis

Wake Forest University Health Sciences81 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

SCREENING

Masking

NONE

Enrollment

Conditions

Intracerebral Hemorrhage Acute Ischemic Stroke

Interventions

Cranial Point of Care UltrasoundPROCEDURE

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Wake Forest University Health Sciences

Winston-Salem, North Carolina, United States

Outcomes

Primary Outcomes

Success Rate for cPOCUS Exams

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

Time frame: Year 1

Data from ClinicalTrials.gov

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