FEMART-1 Pilot Study

NCT07596446 | Recruiting

• 1 other identifier: ZZSHMP_001_2026
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Sudden Cardiac Arrest; Out-of-hospital Cardiac Arrest (OHCA); Cardiogenic Shock Acute

Keywords

ECPR; Femoral Arterial Sheath; Femoral Cannulation; Invasive Blood Pressure Monitoring; Prehospital Care; Emergency Medical Services; Resuscitation; Ultrasound-Guided Vascular Access; OHCA; ROSC; Hemodynamic Monitoring; Refractory Cardiac Arrest; ALS

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (8)

• 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

Study Arms (2)

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.

Procedure: Prehospital Ultrasound-Guided Femoral Arterial Sheath Placement

Standard Prehospital Care

NO INTERVENTION

Patients receive standard advanced prehospital resuscitation and post-resuscitation care without prehospital femoral arterial sheath insertion.

Interventions

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.

Also known as: Femoral Arterial Cannulation, Prehospital Arterial Access, Femoral Arterial Sheath Insertion, Ultrasound-Guided Femoral Access

Prehospital Femoral Arterial Sheath Insertion

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \* 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Emergency Medical Service, Prague: lead
• General University Hospital, Prague: collaborator
• Emergency Medical Service of the Central Bohemian Region, Czech Republic: collaborator

Study Sites (1)

EMS Prague

Prague, 10100, Czechia

RECRUITING

Related Publications (3)

• 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 BACKGROUND

• 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 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.

  PMID: 21621893 BACKGROUND

MeSH Terms

Conditions

Death, Sudden, Cardiac; Out-of-Hospital Cardiac Arrest; Heart Arrest

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Death, Sudden; Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jan Spicak, MD

  Prague Emergency Medical Services

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jan Spicak, MD

CONTACT

00420776155836; jan.spicak@zzshmp.cz

Silvie Trhlikova, MD, PhD

CONTACT

00420607610869; silvie.trhlikova@zzshmp.cz

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 7, 2026
• First Posted: May 19, 2026
• Study Start: May 11, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): March 30, 2027
• Last Updated: May 20, 2026

Record last verified: 2026-05

Locations

CZ (1)