FEMART-1 Pilot Study Evaluating Prehospital Femoral Arterial Sheath Placement
for Invasive Blood Pressure Monitoring in Non-Traumatic Out-of-Hospital Cardiac Arrest
Patients Aged 18 to 70 Years
Led by Emergency Medical Service, Prague · Updated on 2026-05-20
60
Participants Needed
1
Research Sites
12 weeks
Total Duration
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
Research Team
J
Jan Spicak, MD
S
Silvie Trhlikova, MD, PhD
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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
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
Known severe hematological disease with severe thrombocytopenia
Morbid obesity
Known or suspected pregnancy
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
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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Patients Aged 18 to 70 Years
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Published Research Related To This Trial
Prehospital invasive arterial blood pressure monitoring in critically ill patients attended by a UK helicopter emergency medical service- a retrospective observational review of practice.