A randomized trial of expedited intra-arrest transfer versus more extended on-scene resuscitation for refractory out of hospital cardiac arrest: Rationale and design of the EVIDENCE trial - 07/12/23
on behalf of the
EVIDENCE Investigators
ABSTRACT |
Background |
Refractory Out of Hospital Cardiac Arrest (r-OHCA) is common and the benefit versus harm of intra-arrest transport of patients to hospital is not clear.
Objective |
To assess the rate of survival to hospital discharge in adult patients with r-OHCA, initial rhythm pulseless ventricular tachycardia (VT)/ventricular fibrillation (VF) or Pulseless Electrical Activity (PEA) treated with 1 of 2 locally accepted standards of care:1 expedited transport from scene; or2 ongoing advanced life support (ALS) resuscitation on-scene.
Hypothesis |
We hypothesize that expedited transport from scene in r-OHCA improves survival with favorable neurological status/outcome.
Methods/Design |
Phase III, multi-center, partially blinded, prospective, intention-to-treat, safety and efficacy clinical trial with contemporaneous registry of patient ineligible for the clinical trial. Eligible patients for inclusion are adults with witnessed r-OHCA; estimated age 18 to 70, assumed medical cause with immediate bystander cardiopulmonary resuscitation (CPR); initial rhythm of VF/pulseless VT, or PEA; no return of spontaneous circulation following 3 shocks and/or 15 minutes of professional on-scene resuscitation; with mechanical CPR available. Two hundred patients will be randomized in a 1:1 ratio to either expedited transport from scene or ongoing ALS at the scene of cardiac arrest.
Setting |
Two urban regions in NSW Australia.
Outcomes |
Primary: survival to hospital discharge with cerebral performance category (CPC) 1 or 2. Secondary: safety, survival, prognostic factors, use of ECMO supported CPR and functional assessment at hospital discharge and 4 weeks and 6 months, quality of life, healthcare use and cost-effectiveness.
Conclusions |
The EVIDENCE trial will determine the potential risks and benefits of an expedited transport from scene of cardiac arrest.
Il testo completo di questo articolo è disponibile in PDF.Abbreviations : AED, ALS, AR-DRGs, ARR, CCL, CEACs, CHeReL, CPC, CPR, ECG, ECPR, ED, EMS, EQ-5D-5L, ETCO2, hpCPR, ICU, IDSMB, ILCOR, MCPR, MOCA, NNT, NSW, OHCA, PAPA, PCI, PEA, PROCAT, QALYs, REDCap, r-OHCA, ROSC, TRGS, VAS, VF, VT
Mappa
The trial is registered at the Australian Clinical Trial Registry (ACTRN12621000668808). |
Vol 267
P. 22-32 - Gennaio 2024 Ritorno al numeroBenvenuto su EM|consulte, il riferimento dei professionisti della salute.
L'accesso al testo integrale di questo articolo richiede un abbonamento.
Già abbonato a @@106933@@ rivista ?