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Optimization of Transport and Use of a Mobile ECMO Team in Patients With Sudden Cardiac Arrest in the Moravian-Silesian Region

NCT07009652 — Recruiting, 100 participants, University Hospital Ostrava

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Proposal for the Organisation of the Procedure for Extracorporeal Cardiopulmonary Resuscitation of Patients With Sudden Cardiac Arrest in the Pre-hospital Environment of the Moravian-Silesian Region

RegistryNCT07009652
StatusRecruiting
Study typeObservational
Enrollment100 (Estimated)
SponsorUniversity Hospital Ostrava (Other); collaborators: Emergency Medical Services, Moravian-Silesian Region
ConditionsCardiac Arrest With Successful Resuscitation, Cardiac Arrest, Cause Unspecified
InterventionsExtracorporeal cardiopulmonary resuscitation (ECPR) (Procedure)
Datesstart 2025-05-01, primary completion 2026-05-01 (estimated), completion 2028-05-01 (estimated), first posted 2025-06-06, last updated 2025-06-06
Locations2 sites in Czechia

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-Summary

This study evaluates the feasibility of implementing a mobile extracorporeal membrane oxygenation (ECMO) team and optimizing patient transport logistics.

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+Detailed description

The aim of the study is to improve neurological outcomes in out-of-hospital cardiac arrest (OHCA) cases in the Moravian-Silesian Region. By analysing regional epidemiological and demographic data, the project aims to identify key factors for reducing the time from collapse to the initiation of ECMO and to support the development of effective protocols for extracorporeal cardiopulmonary resuscitation (ECPR).

+Arms and interventions

ArmTypeInterventionsDescription
ECPR and ECMOProcedure: Extracorporeal cardiopulmonary resuscitation (ECPR)Patients undergoing extracorporeal cardiopulmonary resuscitation (ECPR).
  • Extracorporeal cardiopulmonary resuscitation (ECPR) (Procedure): Extracorporeal cardiopulmonary resuscitation (commonly known as ECPR) is a method of cardiopulmonary resuscitation (CPR) that passes the patient's blood through a machine in a process to oxygenate the blood supply.

+Outcome measures

Primary outcomes

  • Neurological outcome after 30 days (CPC score) [30 days]: Assessment of the neurological status of patients 30 days after the event using the Cerebral Performance Category (CPC) scale, which measures the extent of neurological impairment: * CPC 1 = good neurological condition * CPC 2 = mild impairment * CPC 3-5 = serious impairment, vegetative state or death The primary endpoint of the study is the proportion of patients with a favourable neurological outcome (CPC 1-2).

Secondary outcomes

  • Time from collapse to initiation of ECMO [Up to 2 hours]: Measuring the time (in minutes) from patient collapse to ECMO initiation. The aim is to analyse how this time affects neurological outcome.
  • Transport time to the ECMO centre [Up to 2 hours]: Measurement of the time (in minutes) from the arrival of the Emergency Medical Services (EMS) at the scene to the admission of the patient to the ECMO centre.
  • Arrival time for the mobile ECMO team to the scene [Up to 2 hours]: Time interval (in minutes) from activation of the mobile ECMO team to its arrival at the scene. The aim is to evaluate the effectiveness of the model and the potential time benefit of intervention in the field.

+Eligibility

Sex: All, ages: 3 Years to 60 Years

Inclusion Criteria:

* out-of-hospital cardiac arrest
* indication for ECPR

Exclusion Criteria:

* death at the scene of the accident
* withdrawal of the informed consent

+Locations (2)

FacilityCityCountryStatus
Emergency Medial Services, Moravian-Silesian RegionOstrava, Moravian-Silesian RegionCzechiaRecruiting
University Hospital OstravaOstrava, Moravian-Silesian RegionCzechiaRecruiting

+Investigators

  • Nela Walachová, Mgr., Principal investigator, University Hospital Ostravs

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