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Completed

NCT Number: NCT05492474

Cranial Ultrasound for Prehospital ICH Diagnosis

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Success Rate for cPOCUS Exams

    Time frame: Year 1

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

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Registry information

Official study title

Cranial Ultrasound for Prehospital ICH Diagnosis (CUPID_EMS)

Acronym: CUPID_EMS

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Aug 8, 2022
Registry last updated
Sep 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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