Cranial Ultrasound for Prehospital ICH Diagnosis

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

Detailed Description
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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.

Official Title
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Cranial Ultrasound for Prehospital ICH Diagnosis (CUPID_EMS)

Conditions
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Intracerebral Hemorrhage, Acute Ischemic Stroke

Intervention / Treatment
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* Procedure: Cranial Point of Care Ultrasound


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Intervention Model: Single Group Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cranial Point of Care Ultrasound<br>Cranial ultrasound involves 2-dimensional B mode imaging of the brain parenchyma in the axial plane | Procedure: Cranial Point of Care Ultrasound<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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computed tomography (CT) scan