Cardiac Arrest, Out-Of-HospitalNCT06491186
Pulse Checks Using Femoral Artery B-Mode Ultrasound With Compressibility Assessment
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 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. 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 Ultrasound
- How many people
- 69 participants
- Where
- 1 siteAustria
- Study dates
- 2 May 2024to 31 Dec 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.
Christina Hafner, MD, PhD contact
Austria1 site, 1 recruiting
- Recruiting
Emergency Medical Service of Vienna
Vienna, 1030
Daniel Grassmann, MD, +43 664 9138434, daniel.grassmann@wien.gv.at
About this study
Official title: 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.
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 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.
- Conditions
- Cardiac Arrest, Out-Of-Hospital
- Being tested
- Point of Care Ultrasound
- Keywords
- Cardiac Arrest, Out-of-hospital Cardiac Arrest, OHCA, Ultrasound, Point-Of-Care Ultrasound, POCUS, Pulse Check, POCUS Pulse Check, B-mode Ultrasound, Femoral Artery, Arterial Compressibility Assessment
- 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 UltrasoundOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Included patients | Not described Receives: Other: Point of Care Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Results of POCUS pulse check
If the femoral artery is both non-compressible and pulsatile, the POCUS pulse check will be considered positive
Measured: 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.
Measured: During cardiac arrest, up to 45 minutes
Secondary outcomes (4)
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.
Measured: 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
Measured: 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
Measured: 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
Measured: During cardiac arrest, up to 45 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2024
- Study start2 May 2024
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
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
- 69 participants (estimated)
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
- NCT06491186
- Sponsor's protocol ID
- 1236/2024
- Status last verified
- Jun 2024
- First submitted
- 1 May 2024
- Last updated
- 9 Jul 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 9 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Femoral Artery Ultrasound With Compressibility Assessment as a Method for Pulse Checks in Out-of-Hospital Cardiac Arrest: A Prospective Exploratory Study.
- ClinicalTrials.gov ID
- NCT06491186
- Acronym / sponsor ID
- 1236/2024
- 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
- Unknown status
- Enrolment
- 69 participants (estimated)
- 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
- 2 May 2024 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 9 Jul 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 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.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Included patients | – | Other: Point of Care 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 UltrasoundPoint-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. | Other | Included patients |
Primary outcome
Results of POCUS pulse check
Time frame: During cardiac arrest, up to 45 minutes
If the femoral artery is both non-compressible and pulsatile, the POCUS pulse check will be considered positive
Results of the concurrently conducted manual pulse check
Time frame: During cardiac arrest, up to 45 minutes
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.
4 secondary outcomes
Arterial compressibility during chest compressions
Time frame: During cardiac arrest, up to 45 minutes
Arterial compressibility during rhythm checks
Time frame: During cardiac arrest, up to 45 minutes
Arterial pulsatility during rhythm checks
Time frame: During cardiac arrest, up to 45 minutes
Time needed for POCUS pulse checks
Time frame: During cardiac arrest, up to 45 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 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.
Christina Hafner, MD, PhD contact
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: status not confirmed, as of the sponsor's last update on 9 Jul 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Philipp Metelka, MD (+43 699 10659528, philipp.metelka@meduniwien.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Results of POCUS pulse check (time frame: During cardiac arrest, up to 45 minutes). The study lists 2 primary outcomes in all. 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 9 Jul 2024.