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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05558228
Other study ID # 19-0274
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date September 6, 2022
Est. completion date September 6, 2024

Study information

Verified date September 2023
Source Northwell Health
Contact Timmy Li, PhD
Phone 516-240-3933
Email tli2@northwell.edu
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 35
Est. completion date September 6, 2024
Est. primary completion date September 6, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Device:
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.

Locations

Country Name City State
United States North Shore University Hospital Manhasset New York

Sponsors (2)

Lead Sponsor Collaborator
Northwell Health Flosonics Medical

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 30 minutes
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