Cranial Ultrasound for Prehospital ICH Diagnosis (CUPID_EMS)

Cranial Ultrasound for Prehospital ICH Diagnosis (CUPID_EMS)

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

Study Overview

• Status: Completed
• Conditions: Acute Ischemic Stroke; Intracerebral Hemorrhage
• Intervention / Treatment: Procedure: Cranial Point of Care Ultrasound

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.

• Study Type: Interventional
• Enrollment (Actual): 81
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest University Health Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Cranial Point of Care Ultrasound; Cranial ultrasound involves 2-dimensional B mode imaging of the brain parenchyma in the axial plane

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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Investigators: Principal Investigator: Aarti Sarwal, MD, Wake Forest University Health Sciences

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2022
• Primary Completion (Actual): April 24, 2023
• Study Completion (Actual): April 24, 2023

Study Registration Dates

• First Submitted: August 4, 2022
• First Submitted That Met QC Criteria: August 4, 2022
• First Posted (Actual): August 8, 2022

Study Record Updates

• Last Update Posted (Actual): September 26, 2024
• Last Update Submitted That Met QC Criteria: September 24, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: computed tomography (CT) scan
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke; Intracranial Hemorrhages; Ischemic Stroke; Hemorrhage; Cerebral Hemorrhage
• Other Study ID Numbers: IRB00077652

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No