Cranial Ultrasound for Prehospital ICH Diagnosis

Acute Ischemic Stroke Clinical Trial

— CUPID_EMS  

Official title:

Cranial Ultrasound for Prehospital ICH Diagnosis (CUPID_EMS)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05492474
• Other study ID #: IRB00077652
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2022
• Est. completion date: July 2024

Study information

• Verified date: August 2023
• Source: Wake Forest University Health Sciences
• Contact: Sahil Kapoor
• Phone: 336.716.2357
• Email: skapoor[@]wakehealth.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: July 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Ischemic Stroke
• Cerebral Hemorrhage
• Hemorrhage
• Intracerebral Hemorrhage
• Ischemic Stroke

Intervention

Procedure:
• Cranial 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.

Locations

Country	Name	City	State
United States	Wake Forest University Health Sciences	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences

Country where clinical trial is conducted

United States, 

Outcome

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