Cardiac Arrest, Out-Of-HospitalNCT06249893
Feasibility of Doppler Ultrasound for Pulse Detection in Out-of-Hospital Cardiac Arrest Patients
An observational study of Cardiac Arrest, Out-Of-Hospital, run by Medical University of Vienna at 1 site in Austria.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Arrest, Out-Of-Hospital
- What is being tested?
- Point-of-care vascular ultrasound
- How many people
- 75 participants
- Where
- 1 siteAustria
- Study dates
- 4 Jan 2024to 18 Apr 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
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.
Who may be able to join
- Out-of-hospital cardiac arrest treated by EMS
- Minimum age of 18 years
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Cardiac Arrest, Out-Of-Hospital
- Being tested
- Point-of-care vascular ultrasound
- Keywords
- Cardiac Arrest, Out-Of-Hospital Cardiac Arrest, OHCA, Ultrasound, Point-Of-Care Ultrasound, POCUS, Pulse Check, POCUS Pulse Check, Doppler Ultrasound, Femoral Artery
- Medical subject headings
- Out-of-Hospital Cardiac Arrest, Heart Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Point-of-care vascular ultrasoundOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Included patients | Not described Receives: Other: Point-of-care vascular ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: During cardiac arrest, up to 45 minutes
Secondary outcomes (5)
Time until ultrasound signal acquisition
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).
Measured: During cardiac arrest, up to 45 minutes
Discordance between doppler ultrasound and manual pulse checks.
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.
Measured: During cardiac arrest, up to 45 minutes
Correlation of the result of manual pulse checks with doppler peak systolic velocity
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.
Measured: During cardiac arrest, up to 45 minutes
Patient factors influencing probability of successful doppler ultrasound image acquisition
Patient factors sex, age, approximated bodyweight and suspected cause of cardiac arrest will be analyzed for correlation with successful doppler ultrasound image acquisition.
Measured: After cardiac arrest, through study completion (a maximum of 1 year)
Inter-observer variability in determining the quality of the doppler ultrasound signal.
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.
Measured: After cardiac arrest, through study completion (a maximum of 1 year)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2024
- Study start4 Jan 2024
- Primary completion18 Apr 2024
- Study completion18 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac Arrest, Out-Of-HospitalStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Collaborators
- Ludwig Boltzmann Institute Digital Health and Patient Safety, Emergency Medical Service of Vienna
- Responsible party
- Principal investigator, Philipp Metelka, Medical University of Vienna
- Investigators
- Philipp Metelka, MD, Principal investigator, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06249893
- Sponsor's protocol ID
- 1549/2023
- Status last verified
- Aug 2024
- First submitted
- 2 Jan 2024
- Last updated
- 7 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Doppler Ultrasound Pulse Detection in Out-of-Hospital Cardiac Arrest Patients: A Feasibility Study.
- ClinicalTrials.gov ID
- NCT06249893
- Acronym / sponsor ID
- 1549/2023
- Conditions
- Cardiac Arrest, Out-Of-Hospital
- Keywords
- Cardiac Arrest, Out-Of-Hospital Cardiac Arrest, OHCA, Ultrasound, Point-Of-Care Ultrasound, POCUS, Pulse Check, POCUS Pulse Check
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Collaborators
- Ludwig Boltzmann Institute Digital Health and Patient Safety, Emergency Medical Service of Vienna
- Study start
- 4 Jan 2024 (actual)
- Primary completion
- 18 Apr 2024 (actual)
- Study completion
- 18 Apr 2024 (actual)
- First posted
- 8 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Included patients | – | Other: Point-of-care vascular ultrasound |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Out-of-hospital cardiac arrest treated by EMS
- Minimum age of 18 years
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Point-of-care vascular ultrasoundPoint-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. | Other | Included patients |
Primary outcome
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.
5 secondary outcomes
Time until ultrasound signal acquisition
Time frame: During cardiac arrest, up to 45 minutes
Discordance between doppler ultrasound and manual pulse checks.
Time frame: 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
Patient factors influencing probability of successful doppler ultrasound image acquisition
Time frame: 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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philipp Metelka, MD principal investigator
Medical University of Vienna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Arrest, Out-Of-Hospital, run by Medical University of Vienna at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of femoral artery doppler ultrasound (time frame: During cardiac arrest, up to 45 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2024.