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

NCT ID: NCT05558228

Last Updated: 2023-09-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

35 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-09-06

Study Completion Date

2024-09-06

Brief Summary

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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

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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

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Cardiac Arrest

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

FloPatch FP120

Intervention Type DEVICE

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.

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.

FloPatch FP120

Intervention Type DEVICE

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.

Interventions

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FloPatch 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.

Intervention Type DEVICE

Eligibility Criteria

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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

* Traumatic cardiac arrest
* Patients without bilateral lower extremities
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Flosonics Medical

UNKNOWN

Sponsor Role collaborator

Northwell Health

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Allison Cohen, MD

Role: PRINCIPAL_INVESTIGATOR

North Shore University Hospital

Locations

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North Shore University Hospital

Manhasset, New York, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Timmy Li, PhD

Role: CONTACT

516-240-3933

Facility Contacts

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Timmy Li, PhD

Role: primary

516-240-3933

Other Identifiers

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19-0274

Identifier Type: -

Identifier Source: org_study_id

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