Prehospital ECPR in Moravia Silesia Region
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Extracorporeal membrane oxygenation (ECMO).
- Who it may be relevant to
- Registry conditions: Cardiac Arrest, Out-Of-Hospital. Basic parameters: 18 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Czechia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Prehospital ECPR in Moravia Silesia Region - Assessing the Effectiveness, Feasibility and Time of ECPR by Simulating Connections and Real Interventions.
Overview
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
- Procedure Extracorporeal membrane oxygenation (ECMO)
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.
Primary outcome measures
- Time from cardiac arrest (collapse) to implantation of ECMO [Time frame: up to 60 minutes]
- Hospital mortality [Time frame: up to 3 weeks]
- Cerebral Performance Category (CPC) score [Time frame: 30 days]
- Neurological outcome (CPC score) [Time frame: 6 months]
- Neurological outcome (SF-36) [Time frame: 6 months]
- Neurological outcome (EQ-5D) [Time frame: 6 months]
Eligibility criteria
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
Czechia · 2 centers
- Emergency Medical Services, Moravian-Silesian Region — Ostrava
- University Hospital Ostrava — Ostrava
Identifiers
NCT: NCT07041086 · FNO-KARIM-01-Pain