AzTrials
AzTrials

Sudden Cardiac ArrestFEMART-1NCT07596446

FEMART-1 Pilot Study

A study testing Prehospital Ultrasound-Guided Femoral Arterial Sheath Placement in people with Sudden Cardiac Arrest and Out-of-hospital Cardiac Arrest (OHCA), run by Emergency Medical Service, Prague at 1 site in Czechia.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

The FEMART-1 Pilot Study is focused on evaluating the feasibility, safety, and procedural timing of prehospital femoral arterial sheath placement in patients with non-traumatic out-of-hospital cardiac arrest (OHCA), both during ongoing cardiopulmonary resuscitation and after return of spontaneous circulation (ROSC). Read more about this study

Who is it for?
Ages 18 to 70 years
What is being tested?
Prehospital Ultrasound-Guided Femoral Arterial Sheath Placement
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteCzechia
Study dates
11 May 2026to 30 Mar 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

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 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Non-traumatic out-of-hospital cardiac arrest (OHCA).
  • Patients meeting criteria for one of the following clinical scenarios:
  • Group A - ECPR-like group:
  • Refractory cardiac arrest, including cardiac arrest occurring in the presence of the EMS crew.
  • Age 18-70 years.
  • Effective bystander cardiopulmonary resuscitation.
Show all 10Show fewer
  • Initial rhythm of ventricular fibrillation (VF), pulseless ventricular tachycardia (pVT), or pulseless electrical activity (PEA).
  • Group B - post-ROSC group:
  • Return of spontaneous circulation (ROSC) after non-traumatic OHCA.
  • Age 18-70 years.

Who cannot join

  • Trauma as the probable primary cause of cardiac arrest.
  • Known severe comorbidity, including:
  • terminal stage of incurable disease (advanced malignancy, advanced dementia, terminal pulmonary disease, terminal heart failure, or palliative care status),
  • established do-not-resuscitate (DNR) status,
  • severe pre-existing neurological disability (CPC 3 or CPC 4),
  • known severe peripheral arterial disease or known occlusion of lower limb arteries,
Show all 10Show fewer
  • suspected pulmonary embolism with indication for thrombolytic therapy,
  • known severe hematological disease associated with severe thrombocytopenia,
  • morbid obesity.
  • Known or suspected pregnancy.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Silvie Trhlikova, MD, PhD contact

00420607610869 ext. MD

silvie.trhlikova@zzshmp.cz

Czechia1 site, 1 recruiting
  • EMS Prague

    Prague, 10100

    Jan Spicak, MD, +420776155836, jan.spicak@zzshmp.cz

    Silvie Trhlikova, MD PhD, +420607610869, silvie.trhlikova@zzshmp.cz

    Recruiting

Other trials in Czechia

About this study

The FEMART-1 Pilot Study is focused on evaluating the feasibility, safety, and procedural timing of prehospital femoral arterial sheath placement in patients with non-traumatic out-of-hospital cardiac arrest (OHCA), both during ongoing cardiopulmonary resuscitation and after return of spontaneous circulation (ROSC).

The primary objective of the study is to enable invasive arterial blood pressure monitoring for targeted and continuous hemodynamic management using vasopressor therapy in the prehospital setting. The study evaluates the feasibility, safety, and procedural performance of invasive arterial monitoring with the aim of improving assessment of the patient's hemodynamic status and enabling more accurate titration of vasopressor support. This approach may reduce episodes of hypotension and decrease the risk of recurrent cardiac arrest while allowing safer transport to specialized cardiac arrest centers.

Read more

Femoral arterial access enables more precise monitoring of perfusion pressure, targeted vasopressor titration, and early recognition of impending circulatory collapse. The intervention may contribute to improved early organ perfusion and could be associated with more favorable neurological and overall clinical outcomes after cardiac arrest. In accordance with the ERC Guidelines 2025, which emphasize active hemodynamic optimization after ROSC and acknowledge the potential role of invasive arterial pressure monitoring during ongoing resuscitation, the study evaluates not only feasibility, safety, and procedural timing, but also the potential clinical benefit of continuous hemodynamic-guided management in the prehospital phase, including (1) early identification of hypotension, (2) targeted vasopressor administration, and (3) prevention of re-arrest.

The study is conducted by the Prague Air Rescue Service Kryštof 01 (Prague Emergency Medical Services) in collaboration with the Central Bohemian Emergency Medical Service, the Second Department of Internal Medicine - Cardiology and Angiology of the General University Hospital in Prague and First Faculty of Medicine, Charles University, and the Department of Anesthesiology, Resuscitation and Intensive Care Medicine of the General University Hospital in Prague and First Faculty of Medicine, Charles University.

FEMART-1 is designed as a prospective pilot study without external funding.

Being tested
Prehospital Ultrasound-Guided Femoral Arterial Sheath Placement
Keywords
ECPR, Femoral Arterial Sheath, Femoral Cannulation, Invasive Blood Pressure Monitoring, Prehospital Care, Emergency Medical Services, Resuscitation, Ultrasound-Guided Vascular Access, OHCA, ROSC, Hemodynamic Monitoring, Refractory Cardiac Arrest, ALS
Medical subject headings
Death, Sudden, Cardiac, 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.

  • Prehospital Ultrasound-Guided Femoral Arterial Sheath PlacementProcedure or surgery

    Also called Femoral Arterial Cannulation, Prehospital Arterial Access, Femoral Arterial Sheath Insertion, Ultrasound-Guided Femoral Access

    Ultrasound-guided placement of a femoral arterial sheath in the prehospital setting during ongoing cardiopulmonary resuscitation or after return of spontaneous circulation. The procedure is performed to enable invasive arterial blood pressure monitoring, optimization of hemodynamic management during ongoing cardiopulmonary resuscitation or post-resuscitation care, prevention of re-arrest, and to facilitate rapid transition to potential VA-ECMO cannulation if clinically indicated.

Study groups in NCT07596446
Study groupRoleWhat they receive
Prehospital Femoral Arterial Sheath InsertionActive comparatorPatients receive standard advanced prehospital resuscitation and post-resuscitation care including ultrasound-guided femoral arterial sheath insertion for invasive blood pressure monitoring and potential facilitation of subsequent VA-ECMO cannulation if clinically indicated.
Receives: Procedure: Prehospital Ultrasound-Guided Femoral Arterial Sheath Placement
Standard Prehospital CareNo interventionPatients receive standard advanced prehospital resuscitation and post-resuscitation care without prehospital femoral arterial sheath insertion.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Patients With Successful and Functional Invasive Arterial Blood Pressure Monitoring

    Feasibility of prehospital femoral arterial sheath placement expressed as the percentage of patients with successfully established and functional invasive arterial blood pressure monitoring among patients in whom prehospital femoral arterial sheath placement was attempted following a clinical decision to perform the procedure.

    Measured: During prehospital care until hospital arrival

  2. Percentage of Patients With Major Procedure-Related Complications

    Safety of prehospital femoral arterial sheath placement expressed as the percentage of patients with major procedure-related complications among patients in whom prehospital femoral arterial sheath placement was attempted following a clinical decision to perform the procedure. Major complications include clinically significant bleeding, vascular injury, distal limb ischemia, or sheath-related complications requiring therapeutic intervention.

    Measured: From sheath insertion until hospital admission

  3. Procedural Time Characteristics of Prehospital Femoral Arterial Sheath Placement

    Assessment of procedural time characteristics of prehospital femoral arterial sheath placement among patients in whom the procedure was attempted following a clinical decision to perform the intervention. Time intervals are assessed using predefined procedural time points recorded during the intervention.

    Measured: During prehospital care until hospital arrival

Secondary outcomes (8)
  1. Use of Vasopressor or Inotropic Therapy in the Prehospital Setting

    Comparison of the number and proportion of patients receiving vasopressor or inotropic therapy during prehospital care.

    Measured: During prehospital care until hospital arrival

  2. Recognition of Impending Hemodynamic Collapse After ROSC

    Comparison of the number and proportion of patients with return of spontaneous circulation who develop hypotension (MAP below 50 mmHg) associated with re-initiation of cardiopulmonary resuscitation, initiation of vasopressor therapy, or escalation of ongoing vasopressor therapy during prehospital care.

    Measured: During prehospital care until hospital arrival

  3. Prehospital Re-arrest Rate

    Comparison of the number and proportion of patients requiring defibrillation or manual/mechanical cardiopulmonary resuscitation after previously achieved return of spontaneous circulation during prehospital care.

    Measured: During prehospital care until hospital arrival

  4. In-Hospital Re-arrest Within 20 Minutes After Handover

    Comparison of the number and proportion of patients transferred to the receiving hospital with return of spontaneous circulation who subsequently require defibrillation or manual/mechanical cardiopulmonary resuscitation within 20 minutes after hospital handover.

    Measured: Within 20 minutes after hospital admission

  5. Adequate Mean Arterial Pressure at Hospital Handover

    Comparison of the number and proportion of patients with mean arterial pressure above 60 mmHg at hospital handover.

    Measured: At hospital admission

  6. Blood Lactate Level at Hospital Admission

    Comparison of median and mean lactate levels measured at hospital admission.

    Measured: At hospital admission

  7. Heart Rate at Hospital Admission

    Comparison of median and mean heart rate measured at hospital admission.

    Measured: At hospital admission

  8. Survival and Neurological Clinical Outcomes

    Comparison of the number and percentage of patients surviving to hospital discharge, surviving with favorable neurological outcome defined as Cerebral Performance Category (CPC) 1-2 at hospital discharge, and surviving 30 days after the index event.

    Measured: Through hospital discharge (up to 30 days) and at 30 days after the index event

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 May 2026
  2. Study start11 May 2026 (estimated)
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion30 Mar 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
FEMART-1 is a prospective observational pilot study focused exclusively on non-traumatic out-of-hospital cardiac arrest (OHCA). The study compares two parallel prehospital management strategies: an invasive strategy including ultrasound-guided femoral arterial sheath placement and a standard non-invasive strategy. Allocation is non-randomized and organizationally determined according to the availability of a trained investigator qualified to perform the procedure. Patients are categorized into two clinical scenarios: (A) refractory cardiac arrest with consideration for ECPR ("ECPR-like" group) and (B) post-ROSC patients after OHCA. Post hoc exploratory stratification according to clinical scenario and management strategy creates four analytical subgroups (1A, 1B, 2A, 2B) for pilot data evaluation and future FEMART-2 trial planning. The study will continue until at least 20 patients are enrolled in the invasive arm.
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07596446
Sponsor's protocol ID
ZZSHMP_001_2026
Acronym
FEMART-1
Status last verified
May 2026
First submitted
7 May 2026
Last updated
20 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: Individual participant data sharing has not yet been determined. Future data sharing decisions will depend on data protection requirements, institutional policies, ethical considerations, and the feasibility of adequate anonymization of prehospital and hospital clinical data.

Publications

  • Ule J, Huppe T, Thiel J, Berwanger U, Schlechtriemen T, Conrad D, Merscher B. Implementing prehospital invasive arterial blood pressure monitoring in critically ill patients-a prospective observational first year analysis. Scand J Trauma Resusc Emerg Med. 2025 Sep 2;33(1):145. doi: 10.1186/s13049-025-01461-9.

    PubMed 40898249
  • Butterfield ED, Price J, Bonsano M, Lachowycz K, Starr Z, Edmunds C, Barratt J, Major R, Rees P, Barnard EBG. Prehospital invasive arterial blood pressure monitoring in critically ill patients attended by a UK helicopter emergency medical service- a retrospective observational review of practice. Scand J Trauma Resusc Emerg Med. 2024 Mar 12;32(1):20. doi: 10.1186/s13049-024-01193-2.

    PubMed 38475832
  • Wildner G, Pauker N, Archan S, Gemes G, Rigaud M, Pocivalnik M, Prause G. Arterial line in prehospital emergency settings - A feasibility study in four physician-staffed emergency medical systems. Resuscitation. 2011 Sep;82(9):1198-201. doi: 10.1016/j.resuscitation.2011.05.002. Epub 2011 May 11.

    PubMed 21621893

Questions about this trial

What is this clinical trial studying?

A study testing Prehospital Ultrasound-Guided Femoral Arterial Sheath Placement in people with Sudden Cardiac Arrest and Out-of-hospital Cardiac Arrest (OHCA), run by Emergency Medical Service, Prague at 1 site in Czechia.

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 10 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 20 May 2026. 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 Czechia. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Jan Spicak, MD (00420776155836, jan.spicak@zzshmp.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Patients With Successful and Functional Invasive Arterial Blood Pressure Monitoring (time frame: During prehospital care until hospital arrival). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07596446, which also lists 3 linked publications.

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 20 May 2026.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in