Pulse Checks Using Femoral Artery B-Mode Ultrasound With Compressibility Assessment

Femoral Artery Ultrasound With Compressibility Assessment as a Method for Pulse Checks in Out-of-Hospital Cardiac Arrest: A Prospective Exploratory Study.

The goal of this prospective observational study is to investigate B-mode point-of care ultrasound with arterial compressibility assessment on the femoral artery as a method to determine the presence of a pulse and to compare it with concurrently conducted manual pulse checks.

Study Overview

• Status: Recruiting
• Conditions: Cardiac Arrest, Out-Of-Hospital
• Intervention / Treatment: Other: Point of Care Ultrasound

Detailed Description

In this prospective observational study, a dedicated research team will be dispatched to cardiac arrest patients treated in the prehospital environment by emergency medical services (EMS). The team will use a portable ultrasound device to identify the femoral artery and employ B-mode ultrasound during rhythm checks. These ultrasound pulse checks will be conducted in parallel with the normal treatment of the patient, including manual pulse checks, and will only be conducted if ultrasound is possible without interference in the resuscitation. All treatment decisions will rest with the treating EMS team.

• Study Type: Observational
• Enrollment (Estimated): 69

Contacts and Locations

• Study Contact: Name: Christina Hafner, MD, PhD; Email: christina.hafner@meduniwien.ac.at
• Study Contact Backup: Name: Philipp Metelka, MD; Phone Number: +43 699 10659528; Email: philipp.metelka@meduniwien.ac.at

Study Locations

• Austria
  • Vienna, Austria, 1030
    • Recruiting
    • Emergency Medical Service of Vienna
    • Contact: Daniel Grassmann, MD; Phone Number: +43 664 9138434; Email: daniel.grassmann@wien.gv.at

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

The study population comprises non-pregnant adults suffering out-of-hospital cardiac arrest of any cause who are treated with CPR by emergency medical services.

Description

Inclusion Criteria:

• Out-of-hospital cardiac arrest treated by EMS
• Minimum age of 18 years

Exclusion Criteria:

• Pregnancy or suspected pregnancy
• Disapproval of the treating EMS team
• Adults under legal guardianship
• Inability to perform femoral artery doppler ultrasound due to limited access to the patient and possible interference with the treating EMS team
• Inability to perform femoral artery doppler ultrasound due to injuries or anatomic abnormalities in the femoral region or necessary emergent medical interventions in the femoral region
• Decision to transfer the patient to the hospital with ongoing CPR for emergent procedures such as extracorporeal CPR before femoral artery doppler ultrasound could be attempted
• Inability to safely perform femoral artery doppler ultrasound due to environmental hazards

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Included patients	Other: Point of Care Ultrasound; Point-of-care ultrasound will be used to image the femoral vessels and to assess the presence or absence of a pulse and the compressibility of the artery during rhythm checks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Results of POCUS pulse check	If the femoral artery is both non-compressible and pulsatile, the POCUS pulse check will be considered positive	During cardiac arrest, up to 45 minutes
Results of the concurrently conducted manual pulse check	Parallel to our study team the treating team will conduct standard care, consisting of determining the presence or absence of a pulse by palpation. The results of these manual pulse checks will be recorded by our study team.	During cardiac arrest, up to 45 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Arterial compressibility during chest compressions	Before each pulse check, during the last 30 seconds of cardiac compressions, the research team will apply pressure with the ultrasound probe until complete collapse of the femoral vein and visually assess if the neighbouring femoral is compressible as well.	During cardiac arrest, up to 45 minutes
Arterial compressibility during rhythm checks	The compressibility of the femoral artery during rhythm checks (part of the "POCUS pulse check" primary outcome) will be recorded and analysed, independently of pulsatility	During cardiac arrest, up to 45 minutes
Arterial pulsatility during rhythm checks	The pulsatility of the femoral artery during rhythm checks (part of the "POCUS pulse check" primary outcome) will be recorded and analysed, independently of compressibility	During cardiac arrest, up to 45 minutes
Time needed for POCUS pulse checks	The POCUS pulse checks will be recorded and the time until presence or absence of a pulse could be determined will be recorded in seconds	During cardiac arrest, up to 45 minutes

Collaborators and Investigators

• Sponsor: Medical University of Vienna
• Collaborators: Ludwig Boltzmann Institute Digital Health and Patient Safety; Emergency Medical Service of Vienna
• Investigators: Principal Investigator: Philipp Metelka, MD, Medical University of Vienna

Study record dates

Study Major Dates

• Study Start (Actual): May 2, 2024
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: May 1, 2024
• First Submitted That Met QC Criteria: June 29, 2024
• First Posted (Actual): July 9, 2024

Study Record Updates

• Last Update Posted (Actual): July 9, 2024
• Last Update Submitted That Met QC Criteria: June 29, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: Ultrasound; Cardiac Arrest; OHCA; Femoral Artery; POCUS; Out-of-hospital Cardiac Arrest; Point-Of-Care Ultrasound; Pulse Check; POCUS Pulse Check; B-mode Ultrasound; Arterial Compressibility Assessment
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Arrest; Out-of-Hospital Cardiac Arrest
• Other Study ID Numbers: 1236/2024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No