Intracerebral HemorrhageCUPID_EMSNCT05492474
Cranial Ultrasound for Prehospital ICH Diagnosis
A study testing Cranial Point of Care Ultrasound in people with Intracerebral Hemorrhage and Acute Ischemic Stroke, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
To evaluate the feasibility of Emergency Medical System (EMS)-performed cPOCUS in the field for diagnosis of acute Intracerebral hemorrhage (ICH) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intracerebral Hemorrhage, Acute Ischemic Stroke
- What is being tested?
- Cranial Point of Care Ultrasound
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2022to 24 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
About this study
Official title: 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)
Read the 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.
- Conditions
- Intracerebral Hemorrhage, Acute Ischemic Stroke
- Being tested
- Cranial Point of Care Ultrasound
- Keywords
- computed tomography (CT) scan
- Medical subject headings
- Cerebral Hemorrhage, Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cranial Point of Care UltrasoundProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Cranial Point of Care Ultrasound | Experimental | Cranial ultrasound involves 2-dimensional B mode imaging of the brain parenchyma in the axial plane Receives: Procedure: Cranial Point of Care Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success Rate for cPOCUS Exams
cPOCUS will be attempted and performed on about 1000 patients over 12 months by 30 EMS providers
Measured: Year 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2022
- Study start1 Sep 2022
- Primary completion24 Apr 2023
- Study completion24 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intracerebral HemorrhageStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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
- Masking
- None (open label)
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aarti Sarwal, MD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05492474
- Sponsor's protocol ID
- IRB00077652
- Acronym
- CUPID_EMS
- Status last verified
- Sep 2024
- First submitted
- 4 Aug 2022
- Last updated
- 26 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article after deidentification (text, tables, figures, and appendices)
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cranial Ultrasound for Prehospital ICH Diagnosis (CUPID_EMS)
- ClinicalTrials.gov ID
- NCT05492474
- Acronym / sponsor ID
- CUPID_EMS / IRB00077652
- Conditions
- Intracerebral Hemorrhage, Acute Ischemic Stroke
- Keywords
- computed tomography (CT) scan
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 24 Apr 2023 (actual)
- Study completion
- 24 Apr 2023 (actual)
- First posted
- 8 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| Cranial Point of Care Ultrasound | Experimental | Procedure: Cranial Point of Care UltrasoundCranial ultrasound involves 2-dimensional B mode imaging of the brain parenchyma in the axial plane |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cranial Point of Care UltrasoundCranial 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. | Procedure or surgery | Cranial Point of Care Ultrasound |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2024.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article after deidentification (text, tables, figures, and appendices)
Related trials for Intracerebral Hemorrhage
Not yet recruiting
BrainGate2: Feasibility Study of an Intracortical Neural Interface System for Persons With Aphasia (BG-Aphasia-01)
Expressive Aphasia, Aphasia Following Cerebral Infarction
RecruitingObservational study
Smartphone Enabled Detection of Cognitive Motor Dissociation in the ICU
Traumatic Brain Injury (TBI) Patients, Intracerebral Hemorrhage
Not yet recruitingObservational study
Integrating Wearable Monitoring and Clinical Data for Stroke Early Warning
Stroke, Ischemic Stroke
Recruiting
Stereotactic Thrombolysis With Tenecteplase for Supratentorial Intracerebral Hemorrhage
Intracerebral Haemorrhage, Minimally Invasive Treatment
RecruitingObservational study
Sleep to Predict Recovery In Unconscious Patients With Acute Brain Injury
Traumatic Brain Injury (TBI) Patients, Intracerebral Hemorrhage (ICH)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aarti Sarwal, MD principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cranial Point of Care Ultrasound in people with Intracerebral Hemorrhage and Acute Ischemic Stroke, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Success Rate for cPOCUS Exams (time frame: Year 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2024.