FEMART-1 Pilot Study

Обзор

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.

Вмешательства

• Процедура Prehospital 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.

Первичные конечные точки

• Percentage of Patients With Successful and Functional Invasive Arterial Blood Pressure Monitoring [Срок оценки: During prehospital care until hospital arrival]
• Percentage of Patients With Major Procedure-Related Complications [Срок оценки: From sheath insertion until hospital admission]
• Procedural Time Characteristics of Prehospital Femoral Arterial Sheath Placement [Срок оценки: During prehospital care until hospital arrival]

Вторичные конечные точки (8)

• Use of Vasopressor or Inotropic Therapy in the Prehospital Setting [Срок оценки: During prehospital care until hospital arrival]
• Recognition of Impending Hemodynamic Collapse After ROSC [Срок оценки: During prehospital care until hospital arrival]
• Prehospital Re-arrest Rate [Срок оценки: During prehospital care until hospital arrival]
• In-Hospital Re-arrest Within 20 Minutes After Handover [Срок оценки: Within 20 minutes after hospital admission]
• Adequate Mean Arterial Pressure at Hospital Handover [Срок оценки: At hospital admission]
• Blood Lactate Level at Hospital Admission [Срок оценки: At hospital admission]
• Heart Rate at Hospital Admission [Срок оценки: At hospital admission]
• Survival and Neurological Clinical Outcomes [Срок оценки: Through hospital discharge (up to 30 days) and at 30 days after the index event]

Критерии участия

Критерии включения

\* 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Чехия · 1 центр

• EMS Prague — Prague

Публикации

• 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. PMID 40898249
• 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. PMID 38475832
• 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. PMID 21621893

Идентификаторы

NCT: NCT07596446 · ZZSHMP_001_2026

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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