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.

Study Overview

• Status: Recruiting
• Conditions: Sudden Cardiac Arrest; Out-of-hospital Cardiac Arrest (OHCA); Cardiogenic Shock Acute
• Intervention / Treatment: Procedure: Prehospital Ultrasound-Guided Femoral Arterial Sheath Placement

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jan Spicak, MD; Phone Number: 00420776155836; Email: jan.spicak@zzshmp.cz
• Study Contact Backup: Name: Silvie Trhlikova, MD, PhD; Phone Number: MD 00420607610869; Email: silvie.trhlikova@zzshmp.cz

Study Locations

• Czechia
  • Prague, Czechia, 10100
    • Recruiting
    • EMS Prague
    • Contact: Jan Spicak, MD; Phone Number: +420776155836; Email: jan.spicak@zzshmp.cz
    • Contact: Silvie Trhlikova, MD PhD; Phone Number: +420607610869; Email: silvie.trhlikova@zzshmp.cz

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Procedure: 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.; Other Names: Femoral Arterial Cannulation; Prehospital Arterial Access; Femoral Arterial Sheath Insertion; Ultrasound-Guided Femoral Access
No Intervention: Standard Prehospital Care; Patients receive standard advanced prehospital resuscitation and post-resuscitation care without prehospital femoral arterial sheath insertion.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Emergency Medical Service, Prague
• Collaborators: General University Hospital, Prague; Emergency Medical Service of the Central Bohemian Region, Czech Republic
• Investigators: Principal Investigator: Jan Spicak, MD, Prague Emergency Medical Services

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): May 11, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): March 30, 2027

Study Registration Dates

• First Submitted: May 7, 2026
• First Submitted That Met QC Criteria: May 12, 2026
• First Posted (Actual): May 19, 2026

Study Record Updates

• Last Update Posted (Actual): May 20, 2026
• Last Update Submitted That Met QC Criteria: May 18, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: ALS; Emergency Medical Services; Resuscitation; OHCA; ROSC; ECPR; Refractory Cardiac Arrest; Hemodynamic Monitoring; Prehospital Care; Femoral Arterial Sheath; Femoral Cannulation; Invasive Blood Pressure Monitoring; Ultrasound-Guided Vascular Access
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Death; Death, Sudden; Pathological Conditions, Signs and Symptoms; Heart Arrest; Death, Sudden, Cardiac; Out-of-Hospital Cardiac Arrest
• Other Study ID Numbers: ZZSHMP_001_2026

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No