NCT06249893

Brief Summary

The goal of this prospective observational study is to investigate the feasibility of using doppler point-of-care ultrasound on the femoral artery with a portable device to assess the presence of a pulse in patients suffering from cardiac arrest in the out-of-hospital environment. The main question is how often researchers are successful in acquiring the necessary ultrasound signal in the out-of-hospital environment.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 2, 2024

Completed
2 days until next milestone

Study Start

First participant enrolled

January 4, 2024

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 8, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 18, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 18, 2024

Completed
Last Updated

August 7, 2024

Status Verified

August 1, 2024

Enrollment Period

4 months

First QC Date

January 2, 2024

Last Update Submit

August 6, 2024

Conditions

Keywords

Cardiac ArrestOut-Of-Hospital Cardiac ArrestOHCAUltrasoundPoint-Of-Care UltrasoundPOCUSPulse CheckPOCUS Pulse CheckDoppler UltrasoundFemoral Artery

Outcome Measures

Primary Outcomes (1)

  • Feasibility of femoral artery doppler ultrasound

    If an ultrasound image of the femoral artery of sufficient quality for Doppler ultrasound can be obtained, the primary outcome will be considered to be positive.

    During cardiac arrest, up to 45 minutes

Secondary Outcomes (5)

  • Time until ultrasound signal acquisition

    During cardiac arrest, up to 45 minutes

  • Discordance between doppler ultrasound and manual pulse checks.

    During cardiac arrest, up to 45 minutes

  • Correlation of the result of manual pulse checks with doppler peak systolic velocity

    During cardiac arrest, up to 45 minutes

  • Patient factors influencing probability of successful doppler ultrasound image acquisition

    After cardiac arrest, through study completion (a maximum of 1 year)

  • Inter-observer variability in determining the quality of the doppler ultrasound signal.

    After cardiac arrest, through study completion (a maximum of 1 year)

Study Arms (1)

Included patients

Other: Point-of-care vascular ultrasound

Interventions

Point-of-care ultrasound will be used to image the femoral vessels and to perform a pulsed-wave doppler measurement of blood flow during chest compressions and during pauses for rhythm and manual pulse checks.

Included patients

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Emergency Medical Service of Vienna

Vienna, 1030, Austria

Location

MeSH Terms

Conditions

Out-of-Hospital Cardiac ArrestHeart Arrest

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Philipp Metelka, MD

    Medical University of Vienna

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr., Resident

Study Record Dates

First Submitted

January 2, 2024

First Posted

February 8, 2024

Study Start

January 4, 2024

Primary Completion

April 18, 2024

Study Completion

April 18, 2024

Last Updated

August 7, 2024

Record last verified: 2024-08

Locations