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| Name | Class |
|---|---|
| General University Hospital, Prague | OTHER |
| Emergency Medical Service of the Central Bohemian Region, Czech Republic | OTHER |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prehospital Femoral Arterial Sheath Insertion | Active Comparator | Patients 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. |
|
| Standard Prehospital Care | No Intervention | Patients receive standard advanced prehospital resuscitation and post-resuscitation care without prehospital femoral arterial sheath insertion. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | During prehospital care until hospital arrival |
| 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. | From sheath insertion until hospital admission |
| 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. | During prehospital care until hospital arrival |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | During prehospital care until hospital arrival |
| Recognition of Impending Hemodynamic Collapse After ROSC |
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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:
Group B - post-ROSC group:
Exclusion Criteria:
Trauma as the probable primary cause of cardiac arrest.
Known severe comorbidity, including:
Known or suspected pregnancy.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jan Spicak, MD | Contact | 00420776155836 | jan.spicak@zzshmp.cz | |
| Silvie Trhlikova, MD, PhD | Contact | 00420607610869 | MD | silvie.trhlikova@zzshmp.cz |
| Name | Affiliation | Role |
|---|---|---|
| Jan Spicak, MD | Prague Emergency Medical Services | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| EMS Prague | Recruiting | Prague | 10100 | Czechia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40898249 | Background | 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. | |
| 38475832 | Background |
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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.
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| ID | Term |
|---|---|
| D016757 | Death, Sudden, Cardiac |
| D058687 | Out-of-Hospital Cardiac Arrest |
| D006323 | Heart Arrest |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D003645 | Death, Sudden |
| D003643 | Death |
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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.
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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. |
| During prehospital care until hospital arrival |
| 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. | During prehospital care until hospital arrival |
| 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. | Within 20 minutes after hospital admission |
| 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. | At hospital admission |
| Blood Lactate Level at Hospital Admission | Comparison of median and mean lactate levels measured at hospital admission. | At hospital admission |
| Heart Rate at Hospital Admission | Comparison of median and mean heart rate measured at hospital admission. | At hospital admission |
| 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. | Through hospital discharge (up to 30 days) and at 30 days after the index event |
| 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. |
| 21621893 | Background | 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. |
| D010335 |
| Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |