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Status unknownNCT05558228Updated Sep 28, 2023

Accuracy of Doppler Ultrasound Versus Manual Palpation of Pulse in Cardiac Arrest

An observational study in Cardiac Arrest, sponsored by Northwell Health. Status unknown at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-09-28.

Sponsored by Northwell Health · Observational

The sponsor has not verified this record recently (last verified Sep 2023), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
35
Ages
18 Years and older
Sex
All
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Study 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. 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.

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Conditions studied

  • Cardiac Arrest

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03

In context

Heart Arrest

984 studies on the registry are indexed under Heart Arrest; 227 are open to participants now.

This study's planned enrollment of 35 is below the median of 196 across 394 observational studies indexed under Heart Arrest.

Browse Heart Arrest studies →

Lead sponsor

Northwell Health is the lead sponsor of 473 studies on the registry; 106 are open to participants now.

Of its 43 completed or terminated interventional studies of FDA-regulated products, 22 (51%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients 18+ years of age in atraumatic cardiac arrest with an arterial line placed in the emergency department during resuscitation.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 18+ years of age
  • In cardiac arrest at the North Shore University Hospital emergency department
  • Arterial line placed during cardiac arrest resuscitation

Exclusion criteria

Exclusion Criteria:

  • Traumatic cardiac arrest
  • Patients without bilateral lower extremities
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
35 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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.

    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.

    Device: FloPatch FP120

Interventions

  • DeviceFloPatch FP120

    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.

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: 30 minutes

07

Study locations

1 of 1 sites recruiting
  • North Shore University Hospital
    Manhasset, New York 11030, United States
    • Timmy Li, PhD · Contact · tli2@northwell.edu · 516-240-3933
    • Allison Cohen, MD · Principal investigator
    • Daniel Rolston, MD · Principal investigator
    • Daniel Jafari, MD · Sub investigator
    Recruiting
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 28, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05558228
Lead sponsor
Northwell Health
Collaborators
Flosonics Medical
Responsible party
Sponsor
First posted
Sep 28, 2022
Start date
Sep 6, 2022
Primary completion
Sep 6, 2024 (estimated)
Completion
Sep 6, 2024 (estimated)
Last update
Sep 28, 2023

Study contacts

Timmy Li, PhD
Contact
tli2@northwell.edu
516-240-3933
Allison Cohen, MD
principal investigator · North Shore University Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.

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