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Prehospital ECPR in Moravia Silesia Region

Prehospital ECPR in Moravia Silesia Region - Assessing the Effectiveness, Feasibility and Time of ECPR by Simulating Connections and Real Interventions.

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07041086
Acronym
01-Pain
Enrollment
100
Registered
2025-06-27
Start date
2025-06-17
Completion date
2028-12-31
Last updated
2026-01-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac Arrest, Out-Of-Hospital

Keywords

ECMO, Cardiac arrest, Cardiopulmonary resuscitation

Brief summary

Cardiopulmonary resuscitation (CPR) for out-of-hospital cardiac arrest (OHCA) in specific cases could be improved by Extracorporeal membrane oxygenation (ECMO; ECPR). ECPR could be introduced in hospital after retrieval of an OHCA patient and also faster by implantation on scene. The aim is to verify the effectiveness of ECPR on scene in the Moravian-Silesian region.

Detailed description

Patients undergoing cardiopulmonary resuscitation (CPR) for out-of-hospital cardiac arrest (OHCA) have a poor prognosis and a good long-term neurological outcome is achieved in about 10% of them. Extracorporeal membrane oxygenation (ECMO) can lead to an improvement in neurological outcome of up to 30% in a selected group of these critically ill patients. CPR for OHCA using ECMO in the hospital after patient admission (ECPR) is very demanding and depends on the best collaboration of pre-hospital care components with the hospital management. As good as the coordination of the different phases of care and transport is, patients often arrive to the hospital relatively late (over 60 minutes), and although the process of diagnosis and indication and ECMO implantation itself is rapid (approximately 15 minutes), the overall time from collapse to ECMO initiation is relatively long (over 60 minutes). It is this time, i.e. the duration of low organ perfusion during CPR, that may be the key parameter in determining the overall neurological outcome of treatment and prognosis of patients. Shortening this interval by having the ECMO team go to well-defined OHCA cases simultaneously with the ambulance car of the Emergency Department and connecting the patient to ECMO already in the field may lead to an improvement in the neurological outcome of the treatment of OHCA patients. In many locations abroad, this model is already used, and patients are connected to ECMO already in the field. Whether the model of field ECPR can be used in the Moravian-Silesian Region depends on a number of variables. These include the logic of information acquisition and selection of suitable patients, the logic of transporting the team and material to the scene, and the logic of connection with the provision of a safe and suitable environment for the ECMO implantation itself. The goal of this study is to validate the feasibility of the method on a simulated ECPR OHCA and further implant the mobile ECPR project in the Moravian-Silesian region.

Interventions

In extracorporeal membrane oxygenation (ECMO), blood is pumped outside of the body to a heart-lung machine. The machine removes carbon dioxide and sends oxygen-rich blood back to the body. Blood flows from the right side of the heart to the heart-lung machine. It's then rewarmed and sent back to the body.

Sponsors

Emergency Medical Services, Moravian-Silesian Region
CollaboratorUNKNOWN
University Hospital Ostrava
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

Inclusion criteria

* Age ≥ 18 years * Observed collapse and presumption of cardiac cause of cardiac arrest * Estimated age up to 70 years * Baseline rhythm of ventricular fibrillation or pulseless electrical activity (PEA) * Basic bystander cardiopulmonary resuscitation (CPR), bystander CPR, telephone assisted CPR (TANR)

Exclusion criteria

* Children or adults with estimated weight below 40 kg * Known major comorbidities of the patient suggesting low rehabilitation potential (e.g. chronic obstructive pulmonary disease (COPD) IV, malignancy in tertiary phase)

Design outcomes

Primary

MeasureTime frameDescription
Time from cardiac arrest (collapse) to implantation of ECMOup to 60 minutesThe time from cardiac arrest (collapse) to implantation of ECMO will be recorded and assessed
Hospital mortalityup to 3 weeksHospital mortality will be assessed for the period of 3 weeks
Cerebral Performance Category (CPC) score30 daysCerebral Performance Category (CPC) score will be observed 30 days after cardiac arrest
Neurological outcome (CPC score)6 monthsNeurological outcome will be assessed using the Cerebral Performance Category Scale (CPC) 6 months after cardiac arrest.
Neurological outcome (SF-36)6 monthsNeurological outcome will be assessed using the Short Form 36 Health Subject Questionnaire (SF-36) 6 months after cardiac arrest.
Neurological outcome (EQ-5D)6 monthsNeurological outcome will be assessed using the European Quality of Life Questionnaire (EQ-5D) 6 months after cardiac arrest.

Countries

Czechia

Contacts

Primary ContactJiří Hynčica
jiri.hyncica@fno.cz0042059737

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026