FEMART-1 Pilot Study
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorEmergency Medical Service, Prague
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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).
Disqualifiers
Trauma as the probable primary cause of cardiac arrest.
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),
Trial design
Design model
Parallel
Treatments tested in this trial
Prehospital Ultrasound-Guided Femoral Arterial Sheath Placement
Procedure/SurgeryUltrasound-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.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Prehospital Femoral Arterial Sheath InsertionActive comparator 1 intervention
Group B: Standard Prehospital CareNo intervention 0 interventions
Trial outcomes
Primary outcomes
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.
Time frame
During prehospital care until hospital arrival2
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.
Time frame
From sheath insertion until hospital admission3
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.
Time frame
During prehospital care until hospital arrivalSecondary outcomes
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.
Time frame
During prehospital care until hospital arrival2
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.
Time frame
During prehospital care until hospital arrival3
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.
Time frame
During prehospital care until hospital arrival4
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.
Time frame
Within 20 minutes after hospital admissionSponsors and contacts
Click on the lead sponsor to view all of their trials.
Emergency Medical Service, Prague
Lead sponsor
General University Hospital, Prague
Collaborator
Emergency Medical Service of the Central Bohemian Region, Czech Republic
Collaborator
Source ClinicalTrials.gov