BACKGROUND: Delayed hypothermia, initiated after hospital arrival, several hours after cardiac arrest with 8-10 hours to reach the target temperature, is likely to have limited impact on overall survival. However, the effect of ultrafast hypothermia, i.e., delivered intra-arrest or immediately after return of spontaneous circulation (ROSC), on functional neurologic outcome after out-of-hospital cardiac arrest (OHCA) is unclear. In two prior trials, prehospital trans-nasal evaporative intra-arrest cooling was safe, feasible and reduced time to target temperature compared to delayed cooling. Both studies showed trends towards improved neurologic recovery in patients with shockable rhythms. The aim of the PRINCESS2-study is to assess whether cooling, initiated either intra-arrest or immediately after ROSC, followed by in-hospital hypothermia, significantly increases survival with complete neurologic recovery as compared to standard normothermia care, in OHCA patients with shockable rhythms. METHODS/DESIGN: In this investigator-initiated, randomized, controlled trial, the emergency medical services (EMS) will randomize patients at the scene of cardiac arrest to either trans-nasal cooling within 20 minutes from EMS arrival with subsequent hypothermia at 33°C for 24 hours after hospital admission (intervention), or to standard of care with no prehospital or in-hospital cooling (control). Fever (>37,7°C) will be avoided for the first 72 hours in both groups. All patients will receive post resuscitation care and withdrawal of life support procedures according to current guidelines. Primary outcome is survival with complete neurologic recovery at 90 days, defined as modified Rankin scale (mRS) 0-1. Key secondary outcomes include survival to hospital discharge, survival at 90 days and mRS 0-3 at 90 days. In total, 1022 patients are required to detect an absolute difference of 9% (from 45 to 54%) in survival with neurologic recovery (80% power and one-sided α=0,025, β=0,2) and assuming 2,5% lost to follow-up. Recruitment starts in Q1 2024 and we expect maximum enrolment to be achieved during Q4 2024 at 20-25 European and US sites. DISCUSSION: This trial will assess the impact of ultrafast hypothermia applied on the scene of cardiac arrest, as compared to normothermia, on 90-day survival with complete neurologic recovery in OHCA patients with initial shockable rhythm. TRIAL REGISTRATION: NCT06025123.

• MeSH
• časové faktory MeSH
• elektrická defibrilace metody   MeSH
• kardiopulmonální resuscitace metody   MeSH
• lidé MeSH
• obnova funkce * MeSH
• obnovení spontánní cirukulace MeSH
• terapeutická hypotermie * metody   MeSH
• urgentní zdravotnické služby * metody   MeSH
• zástava srdce mimo nemocnici * terapie   mortalita   MeSH
• Check Tag
• lidé MeSH
• mužské pohlaví MeSH
• ženské pohlaví MeSH
• Publikační typ
• časopisecké články MeSH
• práce podpořená grantem MeSH
• protokol klinické studie MeSH
• randomizované kontrolované studie MeSH

The use of veno-arterial extracorporeal membrane oxygenation as extracorporeal cardiopulmonary resuscitation in patients suffering out-of-hospital cardiac arrest, largely increased in the last decade despite evidence supporting this practice being limited to non-randomized studies. However, between 2020 and 2023, four randomized studies were published comparing extracorporeal cardiopulmonary resuscitation to conventional cardiopulmonary resuscitation with controversial findings that triggered great debates. In this controversy, we discuss merits and pitfalls, and provide a critical interpretation of the available evidence from randomized trials on the use of extracorporeal cardiopulmonary resuscitation, with a particular focus on the recent multi-center INCEPTION trial.

• Klíčová slova
• ECLS, ECMO, ECPR, OHCA, extracorporeal cardiopulmonary resuscitation, extracorporeal life support, extracorporeal membrane oxygenation, out-of-hospital cardiac arrest,
• MeSH
• kardiopulmonální resuscitace * MeSH
• lidé MeSH
• mimotělní membránová oxygenace * škodlivé účinky   MeSH
• řeky MeSH
• retrospektivní studie MeSH
• zástava srdce mimo nemocnici * terapie   MeSH
• Check Tag
• lidé MeSH
• Publikační typ
• časopisecké články MeSH

PURPOSE: The optimal ventilatory settings in patients after cardiac arrest and their association with outcome remain unclear. The aim of this study was to describe the ventilatory settings applied in the first 72 h of mechanical ventilation in patients after out-of-hospital cardiac arrest and their association with 6-month outcomes. METHODS: Preplanned sub-analysis of the Target Temperature Management-2 trial. Clinical outcomes were mortality and functional status (assessed by the Modified Rankin Scale) 6 months after randomization. RESULTS: A total of 1848 patients were included (mean age 64 [Standard Deviation, SD = 14] years). At 6 months, 950 (51%) patients were alive and 898 (49%) were dead. Median tidal volume (VT) was 7 (Interquartile range, IQR = 6.2-8.5) mL per Predicted Body Weight (PBW), positive end expiratory pressure (PEEP) was 7 (IQR = 5-9) cmH20, plateau pressure was 20 cmH20 (IQR = 17-23), driving pressure was 12 cmH20 (IQR = 10-15), mechanical power 16.2 J/min (IQR = 12.1-21.8), ventilatory ratio was 1.27 (IQR = 1.04-1.6), and respiratory rate was 17 breaths/minute (IQR = 14-20). Median partial pressure of oxygen was 87 mmHg (IQR = 75-105), and partial pressure of carbon dioxide was 40.5 mmHg (IQR = 36-45.7). Respiratory rate, driving pressure, and mechanical power were independently associated with 6-month mortality (omnibus p-values for their non-linear trajectories: p < 0.0001, p = 0.026, and p = 0.029, respectively). Respiratory rate and driving pressure were also independently associated with poor neurological outcome (odds ratio, OR = 1.035, 95% confidence interval, CI = 1.003-1.068, p = 0.030, and OR = 1.005, 95% CI = 1.001-1.036, p = 0.048). A composite formula calculated as [(4*driving pressure) + respiratory rate] was independently associated with mortality and poor neurological outcome. CONCLUSIONS: Protective ventilation strategies are commonly applied in patients after cardiac arrest. Ventilator settings in the first 72 h after hospital admission, in particular driving pressure and respiratory rate, may influence 6-month outcomes.

• Klíčová slova
• Cardiac arrest, Driving pressure, Mechanical power, Mechanical ventilation, Outcome, Ventilator settings,
• MeSH
• dechový objem MeSH
• hypotermie * komplikace   MeSH
• lidé středního věku MeSH
• lidé MeSH
• mechanické ventilátory MeSH
• umělé dýchání MeSH
• zástava srdce mimo nemocnici * komplikace   MeSH
• Check Tag
• lidé středního věku MeSH
• lidé MeSH
• Publikační typ
• časopisecké články MeSH
• práce podpořená grantem MeSH

Rates of survival with functional recovery for both in-hospital and out-of-hospital cardiac arrest are notably low. Extracorporeal cardiopulmonary resuscitation (ECPR) is emerging as a modality to improve prognosis by augmenting perfusion to vital end-organs by utilizing extracorporeal membrane oxygenation (ECMO) during conventional CPR and stabilizing the patient for interventions aimed at reversing the aetiology of the arrest. Implementing this emergent procedure requires a substantial investment in resources, and even the most successful ECPR programs may nonetheless burden healthcare systems, clinicians, patients, and their families with unsalvageable patients supported by extracorporeal devices. Non-randomized and observational studies have repeatedly shown an association between ECPR and improved survival, versus conventional CPR, for in-hospital cardiac arrest in select patient populations. Recently, randomized controlled trials suggest benefit for ECPR over standard resuscitation, as well as the feasibility of performing such trials, in out-of-hospital cardiac arrest within highly coordinated healthcare delivery systems. Application of these data to clinical practice should be done cautiously, with outcomes likely to vary by the setting and system within which ECPR is initiated. ECPR introduces important ethical challenges, including whether it should be considered an extension of CPR, at what point it becomes sustained organ replacement therapy, and how to approach patients unable to recover or be bridged to heart replacement therapy. The economic impact of ECPR varies by health system, and has the potential to outstrip resources if used indiscriminately. Ideally, studies should include economic evaluations to inform health care systems about the cost-benefits of this therapy.

• Klíčová slova
• Cardiac arrest, Extracorporeal cardiopulmonary resuscitation, Extracorporeal membrane oxygenation, IHCA, OHCA,
• MeSH
• analýza nákladů a výnosů MeSH
• dospělí MeSH
• kardiopulmonální resuscitace * metody   MeSH
• lidé MeSH
• mimotělní membránová oxygenace * metody   MeSH
• zástava srdce mimo nemocnici * terapie   MeSH
• Check Tag
• dospělí MeSH
• lidé MeSH
• Publikační typ
• časopisecké články MeSH
• přehledy MeSH

BACKGROUND: Targeted temperature management is recommended for patients after cardiac arrest, but the supporting evidence is of low certainty. METHODS: In an open-label trial with blinded assessment of outcomes, we randomly assigned 1900 adults with coma who had had an out-of-hospital cardiac arrest of presumed cardiac or unknown cause to undergo targeted hypothermia at 33°C, followed by controlled rewarming, or targeted normothermia with early treatment of fever (body temperature, ≥37.8°C). The primary outcome was death from any cause at 6 months. Secondary outcomes included functional outcome at 6 months as assessed with the modified Rankin scale. Prespecified subgroups were defined according to sex, age, initial cardiac rhythm, time to return of spontaneous circulation, and presence or absence of shock on admission. Prespecified adverse events were pneumonia, sepsis, bleeding, arrhythmia resulting in hemodynamic compromise, and skin complications related to the temperature management device. RESULTS: A total of 1850 patients were evaluated for the primary outcome. At 6 months, 465 of 925 patients (50%) in the hypothermia group had died, as compared with 446 of 925 (48%) in the normothermia group (relative risk with hypothermia, 1.04; 95% confidence interval [CI], 0.94 to 1.14; P = 0.37). Of the 1747 patients in whom the functional outcome was assessed, 488 of 881 (55%) in the hypothermia group had moderately severe disability or worse (modified Rankin scale score ≥4), as compared with 479 of 866 (55%) in the normothermia group (relative risk with hypothermia, 1.00; 95% CI, 0.92 to 1.09). Outcomes were consistent in the prespecified subgroups. Arrhythmia resulting in hemodynamic compromise was more common in the hypothermia group than in the normothermia group (24% vs. 17%, P<0.001). The incidence of other adverse events did not differ significantly between the two groups. CONCLUSIONS: In patients with coma after out-of-hospital cardiac arrest, targeted hypothermia did not lead to a lower incidence of death by 6 months than targeted normothermia. (Funded by the Swedish Research Council and others; TTM2 ClinicalTrials.gov number, NCT02908308.).

• MeSH
• horečka etiologie   terapie   MeSH
• jednoduchá slepá metoda MeSH
• Kaplanův-Meierův odhad MeSH
• kardiopulmonální resuscitace metody   MeSH
• kóma etiologie   terapie   MeSH
• lidé středního věku MeSH
• lidé MeSH
• senioři MeSH
• tělesná teplota MeSH
• terapeutická hypotermie * škodlivé účinky   MeSH
• výsledek terapie MeSH
• zástava srdce mimo nemocnici komplikace   mortalita   terapie   MeSH
• Check Tag
• lidé středního věku MeSH
• lidé MeSH
• mužské pohlaví MeSH
• senioři MeSH
• ženské pohlaví MeSH
• Publikační typ
• časopisecké články MeSH
• hodnocení ekvivalence MeSH
• multicentrická studie MeSH
• práce podpořená grantem MeSH
• randomizované kontrolované studie MeSH
• srovnávací studie MeSH

Adequate extracorporeal membrane oxygenation support in the adult requires cannulae permitting blood flows up to 6-8 L/minute. In accordance with Poiseuille's law, flow is proportional to the fourth power of cannula inner diameter and inversely proportional to its length. Poiseuille's law can be applied to obtain the pressure drop of an incompressible, Newtonian fluid (such as water) flowing in a cylindrical tube. However, as blood is a pseudoplastic non-Newtonian fluid, the validity of Poiseuille's law is questionable for prediction of cannula properties in clinical practice. Pressure-flow charts with non-Newtonian fluids, such as blood, are typically not provided by the manufacturers. A standardized laboratory test of return (arterial) cannulae for extracorporeal membrane oxygenation was performed. The aim was to determine pressure-flow data with human whole blood in addition to manufacturers' water tests to facilitate an appropriate choice of cannula for the desired flow range. In total, 14 cannulae from three manufacturers were tested. Data concerning design, characteristics, and performance were graphically presented for each tested cannula. Measured blood flows were in most cases 3-21% lower than those provided by manufacturers. This was most pronounced in the narrow cannulae (15-17 Fr) where the reduction ranged from 27% to 40% at low flows and 5-15% in the upper flow range. These differences were less apparent with increasing cannula diameter. There was a marked disparity between manufacturers. Based on the measured results, testing of cannulae including whole blood flows in a standardized bench test would be recommended.

• Klíčová slova
• arterial, blood, cannula, extracorporeal life support, extracorporeal membrane oxygenation, pressure flow, return, water,
• MeSH
• design vybavení přístrojové vybavení   MeSH
• hemodynamika fyziologie   MeSH
• kanyla * MeSH
• katetrizace metody   MeSH
• lidé MeSH
• mimotělní membránová oxygenace přístrojové vybavení   MeSH
• Check Tag
• lidé MeSH
• Publikační typ
• časopisecké články MeSH

This review summarizes the European rules to control the market when introducing new products. In particular, it shows all the steps to achieve the European Conformity (CE Mark), a certification that all new medical products must achieve before being used in Europe. Extracorporeal membrane oxygenation (ECMO) devices are exposed to the same procedures. Hereby, we present some regulatory issues regarding pumps and oxygenators, providing technical details as released by the manufacturers on their websites and information charts.

• Klíčová slova
• ECLS, ECMO, ISO, centrifugal pumps, oxygenators,
• MeSH
• lidé MeSH
• mimotělní membránová oxygenace metody   MeSH
• podpůrné srdeční systémy normy   MeSH
• Check Tag
• lidé MeSH
• Publikační typ
• časopisecké články MeSH
• přehledy MeSH
• Geografické názvy
• Evropa MeSH

Monitoring brain integrity and neurocognitive function is a new and important target for the management of a patient treated with extracorporeal membrane oxygenation (ECMO), in particular because of the increasing awareness of cerebral abnormalities that may potentially occur in this setting. Continuous regular monitoring, as well as repeated assessment for cerebral complications has become an essential element of the ECMO patient management. Besides well-known complications, like bleeding, ischemic stroke, seizures, and brain hypoperfusion, other less defined yet relevant injury and clinical manifestations are increasingly reported and impacting on ECMO patient prognosis at short term. Furthermore, it is becoming more evident that neurologic complication may not occur only in the early phase. Indeed, other potential adverse events related to the long-term neurocognitive function have been also recently documented either in children or adult ECMO patients. Despite increasing awareness of these aspects, generally accepted protocols and clinical management strategies in this respect are still lacking. Current means to monitor brain perfusion or detecting ongoing cerebral tissue injury are rather limited, and most techniques provide indirect or post-insult recognition of irreversible tissue injury. Continuous monitoring of brain perfusion, serial assessment of brain-derived serum biomarkers, timely neuro-imaging, and post-discharge counselling for neurocognitive dysfunction, particularly in pediatric patients, are novel pathways focusing on neurologic assessment with important implications in daily practice to assess brain function and integrity not only during the ECMO-related hospitalization, but also at long-term to re-evaluate the neuropsychological integrity, although well designed studies will be necessary to elucidate the cost-effectiveness of these management strategies.

• MeSH
• časové faktory MeSH
• intraoperační neurofyziologická monitorace metody   MeSH
• lidé MeSH
• mimotělní membránová oxygenace * MeSH
• mozek fyziologie   MeSH
• Check Tag
• lidé MeSH
• Publikační typ
• časopisecké články MeSH
• přehledy MeSH

INTRODUCTION: The use of extracorporeal CO2 removal (ECCO2R) is increasingly employed in critically ill patients. However, the clinical evidence supporting its efficacy remains currently poor. EVIDENCE ACQUISITION: A systematic review using MEDLINE via PubMed was performed to identify eligible studies (until 30th September 2016). The amount of CO2 reduction, the effect on the duration of mechanical ventilation and weaning, the impact on patients' outcome and the occurrence of complications were evaluated. The quality of evidence was evaluated according to the GRADE (Grading of Recommendations Assessment, Development and Evaluation) criteria. EVIDENCE SYNTHESIS: Six studies were included (three evaluating patients with chronic obstructive pulmonary disease [COPD]; three evaluating patients with acute respiratory distress syndrome [ARDS]), involving 279 adult patients; 142 treated with ECCO2R and 137 controls. No study on pediatric population met the inclusion criteria for analysis. The overall quality of evidence of the two randomized trials and four case-control studies varied from moderate to very low. PaCO2 was generally reduced by 25-33% within a few hours following ECCO2R initiation. One ARDS study showed a significant decrease in the duration of mechanical ventilation, although this result was only found by post-hoc analysis. The three studies on COPD demonstrated that some patients supported by ECCO2R devices could avoid endotracheal intubation, however the ICU-LOS and survival was not influenced by ECCO2R when compared to controls. CONCLUSIONS: In COPD patients, a significantly reduced need for endotracheal intubation was reported. However, the use of ECCO2R has not shown significant improvement on the outcome of critically ill patients in the reviewed studies. Therefore appropriately powered, randomized, controlled studies are urgently needed.

• MeSH
• chronická obstrukční plicní nemoc terapie   MeSH
• kritický stav MeSH
• lidé MeSH
• mimotělní oběh metody   MeSH
• oxid uhličitý * MeSH
• syndrom dechové tísně terapie   MeSH
• výsledek terapie MeSH
• Check Tag
• lidé MeSH
• Publikační typ
• časopisecké články MeSH
• systematický přehled MeSH
• Názvy látek
• oxid uhličitý * MeSH