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

NCT05558228 | Unknown

• 1 other identifier: 19-0274
• Study Type: observational
• Target: 35
• Locations: 1 country
• Sites: 1

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

Outcome Measures

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.

  30 minutes

Study Arms (2)

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

FloPatch FP120 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 achieving return of spontaneous circulation; Patients not achieving return of spontaneous circulation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• Traumatic cardiac arrest
• Patients without bilateral lower extremities

Sponsors & Collaborators

• Northwell Health: lead
• Flosonics Medical: collaborator

Study Sites (1)

North Shore University Hospital

Manhasset, New York, 11030, United States

RECRUITING

MeSH Terms

Conditions

Heart Arrest

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Allison Cohen, MD

  North Shore University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Timmy Li, PhD

CONTACT

516-240-3933; tli2@northwell.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2022
• First Posted: September 28, 2022
• Study Start: September 6, 2022
• Primary Completion: September 6, 2024
• Study Completion: September 6, 2024
• Last Updated: September 28, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)