Hyperinvasive Approach in Cardiac Arrest

Conditions

Out-of Hospital Cardiac Arrest

Keywords

cardiac arrest, mechanical chest compressions, intraarrest cooling, ECLS

Brief summary

Prague out-of Hospital Cardiac Arrest (OHCA) study is a prospective randomized multicenter clinical study comparing use of prehospital intraarrest hypothermia, mechanical chest compression device, extracorporeal life support (ECLS) and early invasive investigation and treatment (coronary angiography/percutaneous coronary intervention \[PCI\]; pulmonary angiography/percutaneous embolectomy; aortography) in all patients with OHCA of presumed cardiac origin compared to standard of care. It is hypothesized, that above stated hyperinvasive approach might improve outcome of out-of hospital cardiac arrest victims.

Detailed description

Background: Out of hospital cardiac arrest (OHCA) has a poor outcome. Recent non-randomized study of ECLS (extracorporeal life support) in OHCA suggested further prospective multicenter studies to define population with OHCA that would benefit from ECLS. Aim: to perform a prospective randomized multicenter clinical study comparing use of prehospital intraarrest hypothermia, mechanical chest compression device, ECLS and early invasive investigation and treatment (coronary angiography/percutaneous coronary intervention \[PCI\]; pulmonary angiography/percutaneous embolectomy; aortography) in all patients with OHCA of presumed cardiac origin compared to standard of care. Planned intervention: patients with witnessed OHCA without ROSC (return of spontaneous circulation) after a minimum of 5 minutes of ACLS by emergency medical service (EMS) team will be after fulfilling of inclusion/exclusion criteria for the study randomized in a 1:1 design to standard vs. hyperinvasive arm. Patients in standard arm will be further managed as per recent guidelines. In hyperinvasive arm, mechanical compression device together with intranasal cooling will be immediately instituted and patients will be transferred to cardiac center directly to cathlab under ongoing CPR. After admission to cathlab, overall status, ROSC and ECLS inclusion/exclusion criteria will be evaluated and in case of no contraindications to ECLS and no ROSC or ROSC with shock, veno-arterial ECLS will be started as soon as possible, not later than 60 minutes after cardiac arrest onset. After ECLS institution, mild hypothermia will be continued by means of ECLS cooling and immediate invasive investigation will be performed in all patients. Standard postresuscitation care will follow.

Smalcova J, Suen J, Huptych M, Franek O, Kavalkova P, Brodska HL, Balik M, Malik J, Pudil J, Smid O, Fajkus M, McInerney MR, Belohlavek J.

2025-05-151 citations

10.1016/j.resuscitation.2025.110642

Effect of intra-arrest transport, extracorporeal cardiopulmonary resuscitation and immediate invasive assessment in refractory out-of-hospital cardiac arrest: a long-term follow-up of the Prague OHCA trial.

Rob D, Farkasovska K, Kreckova M, Smid O, Kavalkova P, Macoun J, Huptych M, Havrankova P, Gallo J, Pudil J, Dusik M, Havranek S, Linhart A, Belohlavek J.

2024-04-1613 citations

10.1186/s13054-024-04901-7

Extracorporeal cardiopulmonary resuscitation-based approach to refractory out-of-hospital cardiac arrest: A focus on organ donation, a secondary analysis of a Prague OHCA randomized study

Jana Šmalcová, Štěpán Havránek, Eva Pokorná, Ondřej Franěk, Michal Huptych et al. (10 authors)

Resuscitation2023-10-0639 citations

10.1016/j.resuscitation.2023.109993

Serum lactate in refractory out-of-hospital cardiac arrest: Post-hoc analysis of the Prague OHCA study

Milan Dusík, Daniel Rob, Jana Šmalcová, Štěpán Havránek, Jiří Karásek et al. (11 authors)

Resuscitation2023-08-1124 citations

10.1016/j.resuscitation.2023.109935

Intraarrest transport, extracorporeal cardiopulmonary resuscitation, and early invasive management in refractory out-of-hospital cardiac arrest: an individual patient data pooled analysis of two randomised trials.

Belohlavek J, Yannopoulos D, Smalcova J, Rob D, Bartos J, Huptych M, Kavalkova P, Kalra R, Grunau B, Taccone FS, Aufderheide TP.

2023-05-0555 citations

10.1016/j.eclinm.2023.101988

Extracorporeal versus conventional cardiopulmonary resuscitation for refractory out-of-hospital cardiac arrest: a secondary analysis of the Prague OHCA trial

Daniel Rob, Jana Šmalcová, Ondřej Šmíd, Aleš Král, Tomáš Kovárník et al. (13 authors)

Critical Care2022-10-2784 citations

10.1186/s13054-022-04199-3

German Cardiac Arrest Registry: rationale and design of G-CAR

Janine Pöss, Christoph Sinning, Isabelle Schreiner, Christian Apfelbacher, Karl Philipp Drewitz et al. (22 authors)

Clinical Research in Cardiology2022-06-218 citations

10.1007/s00392-022-02044-9

Effect of Intra-arrest Transport, Extracorporeal Cardiopulmonary Resuscitation, and Immediate Invasive Assessment and Treatment on Functional Neurologic Outcome in Refractory Out-of-Hospital Cardiac Arrest

Jan Bělohlávek, Jana Šmalcová, Daniel Rob, Ondřej Franěk, Ondřej Šmíd et al. (42 authors)

JAMA2022-02-22616 citations

10.1001/jama.2022.1025

Sub30: Protocol for the Sub30 feasibility study of a pre-hospital Extracorporeal membrane oxygenation (ECMO) capable advanced resuscitation team at achieving blood flow within 30 min in patients with refractory out-of-hospital cardiac arrest.

Singer B, Reynolds JC, Davies GE, Wrigley F, Whitbread M, Faulkner M, O'Brien B, Proudfoot AG, Mathur A, Evens T, Field J, Monk V, Finney SJ, International ECMO Network (ECMONet).

2020-10-0824 citations

10.1016/j.resplu.2020.100029

Hyperinvasive approach to out-of hospital cardiac arrest using mechanical chest compression device, prehospital intraarrest cooling, extracorporeal life support and early invasive assessment compared to standard of care. A randomized parallel groups comparative study proposal. "Prague OHCA study".

Belohlavek J, Kucera K, Jarkovsky J, Franek O, Pokorna M, Danda J, Skripsky R, Kandrnal V, Balik M, Kunstyr J, Horak J, Smid O, Valasek J, Mrazek V, Schwarz Z, Linhart A.

2012-08-1095 citations

10.1186/1479-5876-10-163

Interventions

DEVICEPrehospital mechanical compressions, intraarrest cooling and in hospital ECLS

ECLS states for extracorporeal life support.

OTHERStandard care

Standard care as per recent guidelines will be provided.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

No

Inclusion criteria

* minimum of 18 and maximum of 65 years * witnessed out-of-hospital cardiac arrest of presumed cardiac cause * minimum of 5 minutes of ACLS performed by emergency medical service team without sustained ROSC * unconsciousness (Glasgow Coma Score \< 8) * ECMO team and bed-capacity in cardiac center available.

Exclusion criteria

* OHCA of presumed non-cardiac cause * unwitnessed collapse * pregnancy * sustained ROSC within 5 minutes of ACLS performed by EMS team * conscious patient * known bleeding diathesis or suspected or confirmed acute or recent intracranial bleeding * suspected or confirmed acute stroke * known severe chronic organ dysfunction or other limitations in therapy * do not resuscitate order or other circumstances making 180 day survival unlikely * known pre-arrest cerebral performance category CPC ≥ 3.

Design outcomes

Primary

Measure	Time frame
Composite endpoint of survival with good neurological outcome (CPC 1-2).	6 months

Secondary

Measure	Time frame	Description
Neurological recovery	30 days	Neurological recovery will be defined as no or minimal neurological impairment (CPC 1 or 2) at any timepoint within first 30 days after initial cardiac arrest.
Cardiac recovery	30 days	Cardiac recovery will be assessed by the clinical status of hemodynamic stability defined as no need for pharmacological or mechanical cardiac support. Systolic function will be measured by echocardiography .

Countries

Czechia

Outcome results

None listed