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

Cardiac Arrest Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05558228
• Other study ID #: 19-0274
• Status: Recruiting
• 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
• 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

Related Conditions & MeSH terms

• Cardiac Arrest
• Heart Arrest

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