Actively Recruiting

Phase Not Applicable
Age: 18Years - 70Years
All Genders
ID07596446

FEMART-1 Pilot Study Evaluating Prehospital Femoral Arterial Sheath Placement in Non-Traumatic Out-of-Hospital Cardiac Arrest

Led by Emergency Medical Service, Prague · Updated on 2026-05-20

60

Participants Needed

1

Research Sites

12 weeks

Total Duration

On this page

Sponsors

E

Emergency Medical Service, Prague

Lead Sponsor

G

General University Hospital, Prague

Collaborating Sponsor

AI-Summary

What this Trial Is About

The trial investigates patients who experience non-traumatic out-of-hospital cardiac arrest (OHCA) and aims to study the feasibility, safety, and timing of placing a femoral arterial sheath before they reach the hospital. This procedure allows invasive arterial blood pressure monitoring to manage blood flow and medication more precisely during emergency care. Researchers hope this approach helps prevent low blood pressure and repeated cardiac arrests, potentially improving organ function and neurological outcomes after the event. Participants receive either standard advanced emergency resuscitation and post-resuscitation care with ultrasound-guided femoral arterial sheath placement for blood pressure monitoring and possible support for ECMO treatment if needed, or standard care without the sheath insertion. The study evaluates these two groups during prehospital care until hospital arrival, focusing on procedural success, safety, and timing. During the study, researchers monitor the success of arterial blood pressure measurement, any procedure-related complications, and how quickly the sheath is placed. They also record use of medications to support heart function, rates of repeated cardiac arrest before and just after hospital arrival, blood pressure and heart rate at hospital handover, blood lactate levels, and survival with neurological outcomes up to 30 days after the event. Participation lasts from emergency care through hospital admission and early follow-up.

CONDITIONS

Brief Title

FEMART-1 Pilot Study

Who Can Participate

Age: 18Years - 70Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Non-traumatic out-of-hospital cardiac arrest (OHCA)
  • Age between 18 and 70 years
  • Effective bystander cardiopulmonary resuscitation for cardiac arrest
  • Initial heart rhythm of ventricular fibrillation, pulseless ventricular tachycardia, or pulseless electrical activity for refractory cardiac arrest group
  • Return of spontaneous circulation after OHCA for post-ROSC group
Not Eligible

You will not qualify if you...

  • Trauma as the probable primary cause of cardiac arrest
  • Known severe comorbidities including terminal incurable disease, advanced dementia, terminal pulmonary or 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 occlusion of lower limb arteries
  • Suspected pulmonary embolism needing thrombolytic therapy
  • Known severe hematological disease with severe thrombocytopenia
  • Morbid obesity
  • Known or suspected pregnancy

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - During prehospital care until hospital arrival

Participants receive prehospital advanced resuscitation care. In the intervention group, they undergo ultrasound-guided femoral arterial sheath placement during ongoing cardiopulmonary resuscitation or after return of spontaneous circulation to enable invasive blood pressure monitoring and optimize hemodynamic management.

1 prehospital procedure visit

Follow-up

Duration - Through hospital discharge (up to 30 days) and at 30 days after the index event

Participants are observed through hospital admission and up to 30 days post-event to monitor survival, neurological outcomes, and any procedure-related complications.

Visits at hospital admission and follow-up assessments up to 30 days

Trial Site Locations

Total: 1 location

1

EMS Prague

Prague, Czechia, 10100

Actively Recruiting

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Research Team

J

Jan Spicak, MD

S

Silvie Trhlikova, MD, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

Implementing prehospital invasive arterial blood pressure monitoring in critically ill patients-a prospective observational first year analysis.

Jakob Ule, Tobias Hüppe, Julian Thiel...

https://pubmed.ncbi.nlm.nih.gov/40898249

Prehospital invasive arterial blood pressure monitoring in critically ill patients attended by a UK helicopter emergency medical service- a retrospective observational review of practice.

Emma D Butterfield, James Price, Marco Bonsano...

https://pubmed.ncbi.nlm.nih.gov/38475832

Arterial line in prehospital emergency settings - A feasibility study in four physician-staffed emergency medical systems.

Gernot Wildner, Nina Pauker, Sylvia Archan...

https://pubmed.ncbi.nlm.nih.gov/21621893