Cranial Ultrasound for Prehospital ICH Diagnosis

Not Applicable

Recruiting

• Conditions: Intracerebral Hemorrhage; Acute Ischemic Stroke
• Interventions: Procedure: Cranial Point of Care Ultrasound

• Registration Number: NCT05492474
• Lead Sponsor: Wake Forest University Health Sciences

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.

Study Timeline

• Study First Submitted: 2022-08-04
• Study First Submitted QC: 2022-08-04
• Study First Posted: 2022-08-08
• Study Start: 2022-09-01
• Status Verified: 2023-08
• Last Update Submitted: 2024-06-27
• Last Update Posted: 2024-06-28
• Primary Completion: 2024-08
• Study Completion: 2024-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cranial Point of Care Ultrasound	Cranial Point of Care Ultrasound	Cranial ultrasound involves 2-dimensional B mode imaging of the brain parenchyma in the axial plane

Primary Outcome Measures

Name	Time	Method
Success Rate for cPOCUS Exams	Year 1	cPOCUS will be attempted and performed on about 1000 patients over 12 months by 30 EMS providers

Trial Locations

Locations (1)

Wake Forest University Health Sciences; 🇺🇸 Winston-Salem, North Carolina, United States