Cardiac ArrestNCT05558228
Accuracy of Doppler Ultrasound Versus Manual Palpation of Pulse in Cardiac Arrest
An observational study of Cardiac Arrest, run by Northwell Health at 1 site in United States.
Trial summary
The FloPatch FP120 device is indicated for use for the noninvasive assessment of blood flow in the carotid artery. The FloPatch FP120 device uses ultrasound and the Doppler effect to non-invasively assess the flow of flood. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Arrest
- What is being tested?
- FloPatch FP120
- Type of treatment
- Medical device
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Sep 2022to 6 Sep 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: Patients 18+ years of age in atraumatic cardiac arrest with an arterial line placed in the emergency department during resuscitation.
Who may be able to join
- 18+ years of age
- In cardiac arrest at the North Shore University Hospital emergency department
- Arterial line placed during cardiac arrest resuscitation
Who cannot join
- Traumatic cardiac arrest
- Patients without bilateral lower extremities
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
North Shore University Hospital
Manhasset, New York, 11030
Timmy Li, PhD, 516-240-3933, tli2@northwell.edu
Allison Cohen, MD
About this study
The FloPatch FP120 device is indicated for use for the noninvasive assessment of blood flow in the carotid artery. The FloPatch FP120 device uses ultrasound and the Doppler effect to non-invasively assess the flow of flood. In this study, the FloPatch FP120 will be applied to the neck at the location of the carotid artery on cardiac arrest patients in the emergency department. FloPatch FP120 data will be compared with arterial line blood pressure to assess for accuracy of pulse checks among cardiac arrest patients in the emergency department.
Read the detailed description
The FloPatch FP120 device is indicated for use for the noninvasive assessment of blood flow in the carotid artery. The FloPatch FP120 device uses ultrasound and the Doppler effect to non-invasively assess the flow of flood. In this study, the FloPatch FP120 will be applied to the neck at the location of the carotid artery on cardiac arrest patients in the emergency department. This study will determine the peak systolic velocity, as measured by the FLoPatch FP120 device, that is associated with a systolic blood pressure of ≥60 mmHg on a femoral arterial line in cardiac arrest patients during a pulse check. The associated accuracy, sensitivity, and specificity of the calculated pulse systolic velocity to detect return of spontaneous circulation with a systolic blood pressure ≥60 mmHg in cardiac arrest.
- Conditions
- Cardiac Arrest
- Being tested
- FloPatch FP120
- Medical subject headings
- Heart Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FloPatch FP120Device
FloPatch FP120 is an FDA 510(k) cleared device indicated for the non-invasive assessment of blood flow in the carotid artery by medical professionals, such as physicians and nurses. FloPatch uses ultrasound and the Doppler effect to assess blood flow.
| Study group | Role | What they receive |
|---|---|---|
| Patients achieving return of spontaneous circulation | All patients in cardiac arrest with an arterial line in place in the emergency department will be a potential subject. The FloPatch FP120 device will be placed on patients and the carotid artery peak systolic velocity associated with a systolic blood pressure ≥60 mmHg on a femoral arterial line during a pulse check will be determined. Receives: Device: FloPatch FP120 | |
| Patients not achieving return of spontaneous circulation | All patients in cardiac arrest with an arterial line in place in the emergency department will be a potential subject. The FloPatch FP120 device will be placed on patients and the carotid artery peak systolic velocity associated with a systolic blood pressure ≥60 mmHg on a femoral arterial line during a pulse check will be determined. Receives: Device: FloPatch FP120 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients with Return of Spontaneous Circulation
Any patient achieving any episode of return of spontaneous circulation during a pulse check will be considered as having the outcome. Cardiac arrest resuscitations are typically not longer than 30 minutes.
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2022
- Study start6 Sep 2022
- Primary completion6 Sep 2027 (estimated)
- Study completion6 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac ArrestStudies of the same condition, open and under way.
- More trials run by Northwell HealthThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northwell Health
- Sponsor type
- University, hospital or other
- Collaborators
- Flosonics Medical
- Responsible party
- Sponsor
- Investigators
- Allison Cohen, MD, Principal investigator, North Shore University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05558228
- Sponsor's protocol ID
- 19-0274
- Status last verified
- Oct 2026
- First submitted
- 23 Sep 2022
- Last updated
- 29 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accuracy of Doppler Ultrasound Versus Manual Palpation of Pulse in Cardiac Arrest
- ClinicalTrials.gov ID
- NCT05558228
- Acronym / sponsor ID
- 19-0274
- Conditions
- Cardiac Arrest
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Northwell HealthUniversity, hospital or other
- Collaborators
- Flosonics Medical
- Study start
- 6 Sep 2022 (actual)
- Primary completion
- 6 Sep 2027 (estimated)
- Study completion
- 6 Sep 2027 (estimated)
- First posted
- 28 Sep 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.
The FloPatch FP120 device is indicated for use for the noninvasive assessment of blood flow in the carotid artery. The FloPatch FP120 device uses ultrasound and the Doppler effect to non-invasively assess the flow of flood. In this study, the FloPatch FP120 will be applied to the neck at the location of the carotid artery on cardiac arrest patients in the emergency department. FloPatch FP120 data will be compared with arterial line blood pressure to assess for accuracy of pulse checks among cardiac arrest patients in the emergency department.
Detailed description
The FloPatch FP120 device is indicated for use for the noninvasive assessment of blood flow in the carotid artery. The FloPatch FP120 device uses ultrasound and the Doppler effect to non-invasively assess the flow of flood. In this study, the FloPatch FP120 will be applied to the neck at the location of the carotid artery on cardiac arrest patients in the emergency department. This study will determine the peak systolic velocity, as measured by the FLoPatch FP120 device, that is associated with a systolic blood pressure of ≥60 mmHg on a femoral arterial line in cardiac arrest patients during a pulse check. The associated accuracy, sensitivity, and specificity of the calculated pulse systolic velocity to detect return of spontaneous circulation with a systolic blood pressure ≥60 mmHg in cardiac arrest.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients achieving return of spontaneous circulation | – | Device: FloPatch FP120All patients in cardiac arrest with an arterial line in place in the emergency department will be a potential subject. The FloPatch FP120 device will be placed on patients and the carotid artery peak systolic velocity associated with a systolic blood pressure ≥60 mmHg on a femoral arterial line during a pulse check will be determined. |
| Patients not achieving return of spontaneous circulation | – | Device: FloPatch FP120All patients in cardiac arrest with an arterial line in place in the emergency department will be a potential subject. The FloPatch FP120 device will be placed on patients and the carotid artery peak systolic velocity associated with a systolic blood pressure ≥60 mmHg on a femoral arterial line during a pulse check will be determined. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients 18+ years of age in atraumatic cardiac arrest with an arterial line placed in the emergency department during resuscitation.
Key inclusion criteria (3 listed)
- 18+ years of age
- In cardiac arrest at the North Shore University Hospital emergency department
- Arterial line placed during cardiac arrest resuscitation
Key exclusion criteria (2 listed)
- Traumatic cardiac arrest
- Patients without bilateral lower extremities
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 |
|---|---|---|
| FloPatch FP120FloPatch FP120 is an FDA 510(k) cleared device indicated for the non-invasive assessment of blood flow in the carotid artery by medical professionals, such as physicians and nurses. FloPatch uses ultrasound and the Doppler effect to assess blood flow. | Device | Patients achieving return of spontaneous circulation, Patients not achieving return of spontaneous circulation |
Primary outcome
Number of Patients with Return of Spontaneous Circulation
Time frame: 30 minutes
Any patient achieving any episode of return of spontaneous circulation during a pulse check will be considered as having the outcome. Cardiac arrest resuscitations are typically not longer than 30 minutes.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
- Individual participant dataSharing planned: No
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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.
Allison Cohen, MD principal investigator
North Shore University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Arrest, run by Northwell Health 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 3 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 29 Oct 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Timmy Li, PhD (516-240-3933, tli2@northwell.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Patients with Return of Spontaneous Circulation (time frame: 30 minutes). 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 29 Oct 2026.