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FEMART-1 Pilot Study (FEMART-1)

18 maggio 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Stimato)

60

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Backup dei contatti dello studio

Luoghi di studio

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Non randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore attivo: 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.
Procedura: 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.
Altri nomi:
  • Femoral Arterial Cannulation
  • Prehospital Arterial Access
  • Femoral Arterial Sheath Insertion
  • Ultrasound-Guided Femoral Access
Nessun intervento: Standard Prehospital Care
Patients receive standard advanced prehospital resuscitation and post-resuscitation care without prehospital femoral arterial sheath insertion.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Percentage of Patients With Successful and Functional Invasive Arterial Blood Pressure Monitoring
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Use of Vasopressor or Inotropic Therapy in the Prehospital Setting
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: At hospital admission
Comparison of median and mean lactate levels measured at hospital admission.
At hospital admission
Heart Rate at Hospital Admission
Lasso di tempo: At hospital admission
Comparison of median and mean heart rate measured at hospital admission.
At hospital admission
Survival and Neurological Clinical Outcomes
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Emergency Medical Service, Prague

Collaboratori

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

Investigatori

  • Investigatore principale: Jan Spicak, MD, Prague Emergency Medical Services

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

11 maggio 2026

Completamento primario (Stimato)

31 dicembre 2026

Completamento dello studio (Stimato)

30 marzo 2027

Date di iscrizione allo studio

Primo inviato

7 maggio 2026

Primo inviato che soddisfa i criteri di controllo qualità

12 maggio 2026

Primo Inserito (Effettivo)

19 maggio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

20 maggio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

18 maggio 2026

Ultimo verificato

1 maggio 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • ZZSHMP_001_2026

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

INDECISO

Descrizione del piano IPD

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.

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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