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Prehospital ECPR in Moravia Silesia Region (01-Pain)

U

University Hospital Ostrava

Status

Enrolling

Conditions

Cardiac Arrest, Out-Of-Hospital

Treatments

Procedure: Extracorporeal membrane oxygenation (ECMO)

Study type

Observational

Funder types

Other

Identifiers

NCT07041086
FNO-KARIM-01-Pain

Details and patient eligibility

About

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.

Full 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.

Enrollment

100 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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)

Trial design

100 participants in 1 patient group

Out-of-hospital cardiac arrest on ECMO
Description:
Patients with out-of-hospital cardiac arrest indicated for ECMO
Treatment:
Procedure: Extracorporeal membrane oxygenation (ECMO)

Trial contacts and locations

2

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Central trial contact

Jiří Hynčica

Data sourced from clinicaltrials.gov

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