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

Recruiting

• Conditions: Cardiac Arrest
• Interventions: Device: FloPatch FP120

• Registration Number: NCT05558228
• Lead Sponsor: Northwell Health

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.

Detailed 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.

Study Timeline

• Study Start: 2022-09-06
• Study First Submitted: 2022-09-23
• Study First Submitted QC: 2022-09-23
• Study First Posted: 2022-09-28
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-26
• Last Update Posted: 2023-09-28
• Primary Completion: 2024-09-06
• Study Completion: 2024-09-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 35

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients achieving return of spontaneous circulation	FloPatch FP120	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	FloPatch FP120	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.

Primary Outcome Measures

Name	Time	Method
Number of Patients with Return of Spontaneous Circulation	30 minutes	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.

Trial Locations

Locations (1)

North Shore University Hospital; 🇺🇸 Manhasset, New York, United States