Cranial Ultrasound for Prehospital ICH Diagnosis

NCT05492474 | Completed

• 1 other identifier: IRB00077652
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Intracerebral Hemorrhage; Acute Ischemic Stroke

Keywords

computed tomography (CT) scan

Outcome Measures

Primary Outcomes (1)

• Success Rate for cPOCUS Exams

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

  Year 1

Study Arms (1)

Cranial Point of Care Ultrasound

EXPERIMENTAL

Cranial ultrasound involves 2-dimensional B mode imaging of the brain parenchyma in the axial plane

Procedure: Cranial Point of Care Ultrasound

Interventions

Cranial Point of Care Ultrasound PROCEDURE

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.

Cranial Point of Care Ultrasound

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Cerebral Hemorrhage; Ischemic Stroke

Condition Hierarchy (Ancestors)

Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Stroke

Study Officials

• Aarti Sarwal, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: August 4, 2022
• First Posted: August 8, 2022
• Study Start: September 1, 2022
• Primary Completion: April 24, 2023
• Study Completion: April 24, 2023
• Last Updated: September 26, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Beginning 3 months and ending 5 years following article publication
• Access Criteria: Researchers who provide a methodologically sound proposal

Locations

US (1)