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FEMART-1 Pilot Study (FEMART-1)

18. Mai 2026 aktualisiert von: Emergency Medical Service, Prague

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.

Studienübersicht

Status

Rekrutierung

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Geschätzt)

60

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studieren Sie die Kontaktsicherung

Studienorte

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Nicht randomisiert
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Aktiver Komparator: 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.
Verfahren: 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.
Andere Namen:
  • Femoral Arterial Cannulation
  • Prehospital Arterial Access
  • Femoral Arterial Sheath Insertion
  • Ultrasound-Guided Femoral Access
Kein Eingriff: Standard Prehospital Care
Patients receive standard advanced prehospital resuscitation and post-resuscitation care without prehospital femoral arterial sheath insertion.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Percentage of Patients With Successful and Functional Invasive Arterial Blood Pressure Monitoring
Zeitfenster: 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.
During prehospital care until hospital arrival
Percentage of Patients With Major Procedure-Related Complications
Zeitfenster: 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.
From sheath insertion until hospital admission
Procedural Time Characteristics of Prehospital Femoral Arterial Sheath Placement
Zeitfenster: 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.
During prehospital care until hospital arrival

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Use of Vasopressor or Inotropic Therapy in the Prehospital Setting
Zeitfenster: During prehospital care until hospital arrival
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
Zeitfenster: During prehospital care until hospital arrival
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
Zeitfenster: During prehospital care until hospital arrival
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
Zeitfenster: Within 20 minutes after hospital admission
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
Zeitfenster: At hospital admission
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
Zeitfenster: At hospital admission
Comparison of median and mean lactate levels measured at hospital admission.
At hospital admission
Heart Rate at Hospital Admission
Zeitfenster: At hospital admission
Comparison of median and mean heart rate measured at hospital admission.
At hospital admission
Survival and Neurological Clinical Outcomes
Zeitfenster: Through hospital discharge (up to 30 days) and at 30 days after the index event
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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Emergency Medical Service, Prague

Mitarbeiter

General University Hospital, Prague
Emergency Medical Service of the Central Bohemian Region, Czech Republic

Ermittler

  • Hauptermittler: Jan Spicak, MD, Prague Emergency Medical Services

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

11. Mai 2026

Primärer Abschluss (Geschätzt)

31. Dezember 2026

Studienabschluss (Geschätzt)

30. März 2027

Studienanmeldedaten

Zuerst eingereicht

7. Mai 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

12. Mai 2026

Zuerst gepostet (Tatsächlich)

19. Mai 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

20. Mai 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

18. Mai 2026

Zuletzt verifiziert

1. Mai 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • ZZSHMP_001_2026

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

UNENTSCHIEDEN

Beschreibung des IPD-Plans

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.

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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