FEMART-1 Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Percentage of Patients With Successful and Functional Invasive Arterial Blood Pressure Monitoring
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •* 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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Prehospital Ultrasound-Guided Femoral Arterial Sheath Placement (Procedure)
Standard Prehospital Care
Patients receive standard advanced prehospital resuscitation and post-resuscitation care without prehospital femoral arterial sheath insertion.
结局指标
主要结局
Percentage of Patients With Successful and Functional Invasive Arterial Blood Pressure Monitoring
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
- Use of Vasopressor or Inotropic Therapy in the Prehospital Setting(During prehospital care until hospital arrival)
- Recognition of Impending Hemodynamic Collapse After ROSC(During prehospital care until hospital arrival)
- Prehospital Re-arrest Rate(During prehospital care until hospital arrival)
- In-Hospital Re-arrest Within 20 Minutes After Handover(Within 20 minutes after hospital admission)
- Adequate Mean Arterial Pressure at Hospital Handover(At hospital admission)
- Blood Lactate Level at Hospital Admission(At hospital admission)
- Heart Rate at Hospital Admission(At hospital admission)
- Survival and Neurological Clinical Outcomes(Through hospital discharge (up to 30 days) and at 30 days after the index event)