Feasibility of Doppler Ultrasound for Pulse Detection in Out-of-Hospital Cardiac Arrest Patients

August 6, 2024 updated by: Philipp Metelka, Medical University of Vienna

Doppler Ultrasound Pulse Detection in Out-of-Hospital Cardiac Arrest Patients: A Feasibility Study.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 conduct a pulsed wave (PW) doppler measurement during chest compressions as well as during chest compression pauses for rhythm analysis and save the recorded images. 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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
75

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Austria
      • Vienna, Austria, 1030
        • Emergency Medical Service of Vienna

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Included patients
Other: Point-of-care vascular ultrasound
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Feasibility of femoral artery doppler ultrasound
Time Frame: During cardiac arrest, up to 45 minutes
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Time until ultrasound signal acquisition
Time Frame: During cardiac arrest, up to 45 minutes
The time until successful acquisition of the doppler ultrasound signal will be measured in 2-minute CPR-intervals and 30-second intervals (e.g. second CPR-interval, first 30 seconds).
During cardiac arrest, up to 45 minutes
Discordance between doppler ultrasound and manual pulse checks.
Time Frame: During cardiac arrest, up to 45 minutes
The presence of a doppler ultrasound flow signal during rhythm analysis and the result of the manual pulse check that is performed in parallel by the treating EMS team will be evaluated and analyzed for discordance.
During cardiac arrest, up to 45 minutes
Correlation of the result of manual pulse checks with doppler peak systolic velocity
Time Frame: During cardiac arrest, up to 45 minutes
The correlation of the result of manual pulse checks performed by the treating EMS team with the peak systolic velocity measured by doppler ultrasound will be analyzed.
During cardiac arrest, up to 45 minutes
Patient factors influencing probability of successful doppler ultrasound image acquisition
Time Frame: After cardiac arrest, through study completion (a maximum of 1 year)
Patient factors sex, age, approximated bodyweight and suspected cause of cardiac arrest will be analyzed for correlation with 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.
Time Frame: After cardiac arrest, through study completion (a maximum of 1 year)
The sonographer on site will assess the quality of the acquired doppler ultrasound images, as well as two ultrasound experts who will be blinded to the performing sonographer. The difference between these assessments will be analyzed.
After cardiac arrest, through study completion (a maximum of 1 year)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Medical University of Vienna

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Ludwig Boltzmann Institute Digital Health and Patient Safety
Emergency Medical Service of Vienna

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Philipp Metelka, MD, Medical University of Vienna

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 4, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 18, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 18, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 2, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 31, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 8, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 7, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 6, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1549/2023

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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