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NCT Number: NCT07596446

FEMART-1 Pilot 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.

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.

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Key information

Conditions

Sudden Cardiac Arrest Cardiogenic Shock Acute Cardiovascular Diseases Death Death, Sudden Death, Sudden, Cardiac Heart Arrest Heart Diseases Out-Of-Hospital Cardiac Arrest (OHCA) Out-of-Hospital Cardiac Arrest Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.
  • 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.

Exclusion criteria

  • 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,
  • suspected pulmonary embolism with indication for thrombolytic therapy,
  • known severe hematological disease associated with severe thrombocytopenia,
  • morbid obesity.
  • Known or suspected pregnancy.

Treatment and study plan

Prehospital Ultrasound-Guided Femoral Arterial Sheath Placement

Procedure

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.

Other names: Femoral Arterial Cannulation, Prehospital Arterial Access, Femoral Arterial Sheath Insertion, Ultrasound-Guided Femoral Access

Primary outcomes

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

    Time frame: During prehospital care until hospital arrival

    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.

  2. Percentage of Patients With Major Procedure-Related Complications

    Time frame: From sheath insertion until hospital admission

    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.

  3. Procedural Time Characteristics of Prehospital Femoral Arterial Sheath Placement

    Time frame: During prehospital care until hospital arrival

    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.

Secondary outcomes

  1. Use of Vasopressor or Inotropic Therapy in the Prehospital Setting

    Time frame: During prehospital care until hospital arrival

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

  2. Recognition of Impending Hemodynamic Collapse After ROSC

    Time frame: During prehospital care until hospital arrival

    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.

  3. Prehospital Re-arrest Rate

    Time frame: During prehospital care until hospital arrival

    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.

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

    Time frame: Within 20 minutes after hospital admission

    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.

  5. Adequate Mean Arterial Pressure at Hospital Handover

    Time frame: At hospital admission

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

  6. Blood Lactate Level at Hospital Admission

    Time frame: At hospital admission

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

  7. Heart Rate at Hospital Admission

    Time frame: At hospital admission

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

  8. Survival and Neurological Clinical Outcomes

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

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Jan Spicak, MD

CONTACT

[email protected]

00420776155836

Silvie Trhlikova, MD, PhD

CONTACT

[email protected]

00420607610869 ext. MD

Sponsors and collaborators

Lead sponsor

Emergency Medical Service, Prague

Other Gov

Collaborators

  • Emergency Medical Service of the Central Bohemian Region, Czech Republic
  • General University Hospital, Prague

Registry information

Acronym: FEMART-1

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
May 19, 2026
Registry last updated
May 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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