Cardiogenic Shock Acute, Out-of-hospital Cardiac Arrest (OHCA), Sudden Cardiac Arrest
Conditions
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
Brief 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). 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.
Interventions
PROCEDUREPrehospital Ultrasound-Guided Femoral Arterial Sheath Placement
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.
Sponsors
Emergency Medical Service, Prague
General University Hospital, Prague
Emergency Medical Service of the Central Bohemian Region, Czech Republic
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Patients With Successful and Functional Invasive Arterial Blood Pressure Monitoring | 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. |
| Percentage of Patients With Major Procedure-Related Complications | 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. |
| Procedural Time Characteristics of Prehospital Femoral Arterial Sheath Placement | 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
| Measure | Time frame | Description |
|---|---|---|
| Use of Vasopressor or Inotropic Therapy in the Prehospital Setting | During prehospital care until hospital arrival | Comparison of the number and proportion of patients receiving vasopressor or inotropic therapy during prehospital care. |
| Recognition of Impending Hemodynamic Collapse After ROSC | 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. |
| Prehospital Re-arrest Rate | 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. |
| In-Hospital Re-arrest Within 20 Minutes After Handover | 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. |
| Adequate Mean Arterial Pressure at Hospital Handover | At hospital admission | Comparison of the number and proportion of patients with mean arterial pressure above 60 mmHg at hospital handover. |
| Blood Lactate Level at Hospital Admission | At hospital admission | Comparison of median and mean lactate levels measured at hospital admission. |
| Heart Rate at Hospital Admission | At hospital admission | Comparison of median and mean heart rate measured at hospital admission. |
| Survival and Neurological Clinical Outcomes | 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. |
Countries
Czechia
Contacts
CONTACTJan Spicak, MD
CONTACTSilvie Trhlikova, MD, PhD
PRINCIPAL_INVESTIGATORJan Spicak, MD
Prague Emergency Medical Services
Outcome results
None listed