FEMART-1 Pilot Study (FEMART-1)
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.
Descripción general del estudio
Estado
Intervención / Tratamiento
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Jan Spicak, MD
- Número de teléfono: 00420776155836
- Correo electrónico: jan.spicak@zzshmp.cz
Copia de seguridad de contactos de estudio
- Nombre: Silvie Trhlikova, MD, PhD
- Número de teléfono: MD 00420607610869
- Correo electrónico: silvie.trhlikova@zzshmp.cz
Ubicaciones de estudio
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Prague, Chequia, 10100
- Reclutamiento
- EMS Prague
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Contacto:
- Jan Spicak, MD
- Número de teléfono: +420776155836
- Correo electrónico: jan.spicak@zzshmp.cz
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Contacto:
- Silvie Trhlikova, MD PhD
- Número de teléfono: +420607610869
- Correo electrónico: silvie.trhlikova@zzshmp.cz
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Comparador activo: Prehospital Femoral Arterial Sheath Insertion
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.
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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.
Otros nombres:
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Sin intervención: Standard Prehospital Care
Patients receive standard advanced prehospital resuscitation and post-resuscitation care without prehospital femoral arterial sheath insertion.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Percentage of Patients With Successful and Functional Invasive Arterial Blood Pressure Monitoring
Periodo de tiempo: During prehospital care until hospital arrival
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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.
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During prehospital care until hospital arrival
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Percentage of Patients With Major Procedure-Related Complications
Periodo de tiempo: From sheath insertion until hospital admission
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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.
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From sheath insertion until hospital admission
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Procedural Time Characteristics of Prehospital Femoral Arterial Sheath Placement
Periodo de tiempo: During prehospital care until hospital arrival
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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.
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During prehospital care until hospital arrival
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Use of Vasopressor or Inotropic Therapy in the Prehospital Setting
Periodo de tiempo: During prehospital care until hospital arrival
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Comparison of the number and proportion of patients receiving vasopressor or inotropic therapy during prehospital care.
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During prehospital care until hospital arrival
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Recognition of Impending Hemodynamic Collapse After ROSC
Periodo de tiempo: During prehospital care until hospital arrival
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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.
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During prehospital care until hospital arrival
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Prehospital Re-arrest Rate
Periodo de tiempo: During prehospital care until hospital arrival
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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.
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During prehospital care until hospital arrival
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In-Hospital Re-arrest Within 20 Minutes After Handover
Periodo de tiempo: Within 20 minutes after hospital admission
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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.
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Within 20 minutes after hospital admission
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Adequate Mean Arterial Pressure at Hospital Handover
Periodo de tiempo: At hospital admission
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Comparison of the number and proportion of patients with mean arterial pressure above 60 mmHg at hospital handover.
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At hospital admission
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Blood Lactate Level at Hospital Admission
Periodo de tiempo: At hospital admission
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Comparison of median and mean lactate levels measured at hospital admission.
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At hospital admission
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Heart Rate at Hospital Admission
Periodo de tiempo: At hospital admission
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Comparison of median and mean heart rate measured at hospital admission.
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At hospital admission
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Survival and Neurological Clinical Outcomes
Periodo de tiempo: Through hospital discharge (up to 30 days) and at 30 days after the index event
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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.
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Through hospital discharge (up to 30 days) and at 30 days after the index event
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Jan Spicak, MD, Prague Emergency Medical Services
Publicaciones y enlaces útiles
Publicaciones Generales
- 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.
- 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.
- 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.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- ZZSHMP_001_2026
Plan de datos de participantes individuales (IPD)
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Descripción del plan IPD
Información sobre medicamentos y dispositivos, documentos del estudio
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