Recruiting

FloPatch FP120

Sponsor:

Northwell Health

Code:

NCT05558228

Conditions

Cardiac Arrest

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

FloPatch FP120

Study Details

Brief 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.

Conditions

Cardiac Arrest

Study ID

NCT05558228

Start date

Sep 6, 2022

Status verified date

Sep, 2023

Completion date

Sep 6, 2024

Anticipated

Primary completion date

Sep 6, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

35 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

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.

Interventions

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.

Primary outcome measure

  • Number of Patients with Return of Spontaneous Circulation [ Time Frame: 30 minutes ]

Central Contacts and Locations

Central contacts

Timmy Li, PhD

516-240-3933tli2@northwell.edu

Locations

North Shore University Hospital

Recruiting

Manhasset, New York, United States, 11030

Contacts

Timmy Li, PhD

516-240-3933tli2@northwell.edu

Principal Investigator:

Allison Cohen, MD

More Information

Sponsor

Northwell Health

Last update posted

Sep 28, 2023

Last verified

Sep, 2023

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Northwell Health on 2023-09-28.