Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
50 participants
OBSERVATIONAL
2021-10-25
2028-01-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Out-of-hospital cardiac arrest
Patients with out-of-hospital cardiac arrest which occured in the predefined area of the city of Wroclaw.
ECMO assisted CPR in out-of-hospital cardiac arrest
Patients included in the registry will be transferred during LUCAS assisted CPR by the Wroclaw Emergency Medical Services to the Emergency Department of the Wroclaw University Hospital where blood gasses will be assessed. If two or more of the following: end-tidal carbon dioxide (CO2) \> 10 mm Hg, arterial partial pressure of oxygen (PaO2) \>50 mm Hg or oxygen saturation \>85%, and lactic acid \<18 mmol/L will be fulfilled patient will be further transferred to the Cardiac Catheterization Laboratory for V-A ECMO implantation followed by coronary/pulmonary artery angiography and intervention.
Interventions
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ECMO assisted CPR in out-of-hospital cardiac arrest
Patients included in the registry will be transferred during LUCAS assisted CPR by the Wroclaw Emergency Medical Services to the Emergency Department of the Wroclaw University Hospital where blood gasses will be assessed. If two or more of the following: end-tidal carbon dioxide (CO2) \> 10 mm Hg, arterial partial pressure of oxygen (PaO2) \>50 mm Hg or oxygen saturation \>85%, and lactic acid \<18 mmol/L will be fulfilled patient will be further transferred to the Cardiac Catheterization Laboratory for V-A ECMO implantation followed by coronary/pulmonary artery angiography and intervention.
Eligibility Criteria
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Inclusion Criteria
* witnessed sudden cardiac arrest with immediate CPR
* supposed cardiac cause of the event
* ventricular fibrillation (VF) or pulseless ventricular tachycardia (VT) at first medical contact with 3 unsuccessful defibrillations (no ROSC)
* CPR conducted with Lund University Cardiopulmonary Assist System (LUCAS™)
* Estimated transfer time from the scene to the Emergency Department \< 30 minutes.
* End tidal carbon dioxide (ETCO2) \> 10 mmHg
Exclusion Criteria
* Age \< 18 years old or \> 60 years old;
* Non-shockable initial rhythm
* Unavailability of the automated CPR device
* Unavailability of the catheterisation laboratory
* Severe concomitant illness with decreased life expectancy
* Severe body injury
* Severe active bleeding
* Drowning
* Terminal cancer
18 Years
60 Years
ALL
No
Sponsors
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Wroclaw Emergency Medical Services
UNKNOWN
Wroclaw Medical University
OTHER
Responsible Party
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Wiktor Kuliczkowski
Head of the Cardiac Catheterisation Laboratory
Principal Investigators
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Wiktor Kuliczkowski, MD
Role: PRINCIPAL_INVESTIGATOR
Wroclaw Medical University
Locations
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Wroclaw University Hostpital
Wroclaw, , Poland
Countries
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Central Contacts
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Facility Contacts
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References
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Sip M, Puslecki M, Klosiewicz T, Zalewski R, Dabrowski M, Ligowski M, Goszczynska E, Paprocki C, Grygier M, Lesiak M, Jemielity M, Perek B. A concept for the development of a pioneer regional Out-of-Hospital Cardiac Arrest Program to improve patient outcomes. Kardiol Pol. 2020 Sep 25;78(9):875-881. doi: 10.33963/KP.15433. Epub 2020 Jun 16.
Yannopoulos D, Bartos J, Raveendran G, Walser E, Connett J, Murray TA, Collins G, Zhang L, Kalra R, Kosmopoulos M, John R, Shaffer A, Frascone RJ, Wesley K, Conterato M, Biros M, Tolar J, Aufderheide TP. Advanced reperfusion strategies for patients with out-of-hospital cardiac arrest and refractory ventricular fibrillation (ARREST): a phase 2, single centre, open-label, randomised controlled trial. Lancet. 2020 Dec 5;396(10265):1807-1816. doi: 10.1016/S0140-6736(20)32338-2. Epub 2020 Nov 13.
Other Identifiers
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327/2021
Identifier Type: -
Identifier Source: org_study_id
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