Skip to content

Cranial Ultrasound for Prehospital ICH Diagnosis

Cranial Ultrasound for Prehospital ICH Diagnosis (CUPID_EMS)

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05492474
Acronym
CUPID_EMS
Enrollment
81
Registered
2022-08-08
Start date
2022-09-01
Completion date
2023-04-24
Last updated
2024-09-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Ischemic Stroke, Intracerebral Hemorrhage

Keywords

computed tomography (CT) scan

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.

Interventions

PROCEDURECranial Point of Care Ultrasound

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.

Sponsors

Wake Forest University Health Sciences
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE

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

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Success Rate for cPOCUS ExamsYear 1cPOCUS will be attempted and performed on about 1000 patients over 12 months by 30 EMS providers

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026