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

Sponsor
Northwell Health (Other)
Overall Status
Recruiting
CT.gov ID
NCT05558228
Collaborator
Flosonics Medical (Other)
35
1
24
1.5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: FloPatch FP120

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 Design

Study Type:
Observational
Anticipated Enrollment :
35 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Accuracy of Doppler Ultrasound Versus Manual Palpation of Pulse in Cardiac Arrest
Actual Study Start Date :
Sep 6, 2022
Anticipated Primary Completion Date :
Sep 6, 2023
Anticipated Study Completion Date :
Sep 6, 2024

Arms and Interventions

Arm Intervention/Treatment
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
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 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
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.

Outcome Measures

Primary Outcome Measures

  1. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 North Shore University Hospital Manhasset New York United States 11030

Sponsors and Collaborators

  • Northwell Health
  • Flosonics Medical

Investigators

  • Principal Investigator: Allison Cohen, MD, North Shore University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Northwell Health
ClinicalTrials.gov Identifier:
NCT05558228
Other Study ID Numbers:
  • 19-0274
First Posted:
Sep 28, 2022
Last Update Posted:
Sep 28, 2022
Last Verified:
Sep 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 28, 2022