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PURPOSE: Patients receiving venoarterial extracorporeal membrane oxygenation (VA-ECMO) frequently develop arterial hyperoxaemia, which may be harmful. However, lower oxygen saturation targets may also lead to harmful episodes of hypoxaemia. METHODS: In this registry-embedded, multicentre trial, we randomly assigned adult patients receiving VA-ECMO in an intensive care unit (ICU) to either a conservative (target SaO2 92-96%) or to a liberal oxygen strategy (target SaO2 97-100%) through controlled oxygen administration via the ventilator and ECMO gas blender. The primary outcome was the number of ICU-free days to day 28. Secondary outcomes included ICU-free days to day 60, mortality, ECMO and ventilation duration, ICU and hospital lengths of stay, and functional outcomes at 6 months. RESULTS: From September 2019 through June 2023, 934 patients who received VA-ECMO were reported to the EXCEL registry, of whom 300 (192 cardiogenic shock, 108 refractory cardiac arrest) were recruited. We randomised 149 to a conservative and 151 to a liberal oxygen strategy. The median number of ICU-free days to day 28 was similar in both groups (conservative: 0 days [interquartile range (IQR) 0-13.7] versus liberal: 0 days [IQR 0-13.7], median treatment effect: 0 days [95% confidence interval (CI) - 3.1 to 3.1]). Mortality at day 28 (59/159 [39.6%] vs 59/151 [39.1%]) and at day 60 (64/149 [43%] vs 62/151 [41.1%] were similar in conservative and liberal groups, as were all other secondary outcomes and adverse events. The conservative group experienced 44 (29.5%) major protocol deviations compared to 2 (1.3%) in the liberal oxygen group (P < 0.001). CONCLUSIONS: In adults receiving VA-ECMO in ICU, a conservative compared to a liberal oxygen strategy, did not affect the number of ICU-free days to day 28.

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Oxigenación por Membrana Extracorpórea , Humanos , Oxigenación por Membrana Extracorpórea/métodos , Oxigenación por Membrana Extracorpórea/efectos adversos , Masculino , Femenino , Persona de Mediana Edad , Anciano , Adulto , Unidades de Cuidados Intensivos/estadística & datos numéricos , Saturación de Oxígeno/fisiología , Sistema de Registros/estadística & datos numéricos , Oxígeno , Choque Cardiogénico/terapia , Choque Cardiogénico/mortalidad , Paro Cardíaco/terapia , Paro Cardíaco/mortalidad

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[This corrects the article DOI: 10.1016/j.ccrj.2023.06.001.].

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BACKGROUND: Medication errors in the intensive care setting continue to occur at significant rates and are often associated with adverse events and potentially life-threatening repercussions. AIM/OBJECTIVE: The aim of this study was to (i) determine the frequency and severity of medication errors reported in the incident management reporting system; (ii) examine the antecedent events, their nature, the circumstances, risk factors, and contributing factors leading to medication errors; and (iii) identify strategies to improve medication safety in the intensive care unit (ICU). METHOD: A retrospective, exploratory, descriptive design was selected. Retrospective data were collected from the incident report management system and electronic medical records over a 13-month period from a major metropolitan teaching hospital ICU. RESULTS: A total of 162 medication errors were reported during a 13-month period, of which, 150 were eligible for inclusion. Most medication errors occurred during the administration (89.4%) and dispensing phases (23.3%). The highest reported errors included incorrect doses (25.3%), incorrect medications (12.7%), omissions (10.7%), and documentation errors (9.3%). Narcotic analgesics (20%), anaesthetics (13.3%), and immunomodifiers (10.7%) were the most frequently reported medication classes associated with medication errors. Prevention strategies were found to be focussed on active errors (67.7%) as opposed to latent errors (32.3%) and included various and infrequent levels of education and follow-up. Active antecedent events included action-based errors (39%) and rule-based errors (29.5%), whereas latent antecedent events were most associated with a breakdown in system safety (39.3%) and education (25%). CONCLUSION: This study presents an epidemiological view and understanding of medication errors in an Australian ICU. This study highlighted the preventable nature of most medication errors in this study. Improving administration-checking procedures would prevent the occurrence of many medication errors. Approaches aimed at both individual- and organisational-level improvements are recommended to address administration errors and inconsistent medication-checking procedures. Areas for further research include determining the most effective system developments for improving administration-checking procedures and verifying the risk and prevalence of immunomodifier administration errors in the ICU as this is an area not reported previously in the literature. In addition, the impact of single- versus two-person checking procedures on medication errors in the ICU should be prioritised to address current evidence gaps.

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Unidades de Cuidados Intensivos , Errores de Medicación , Humanos , Estudios Retrospectivos , Australia , Errores de Medicación/prevención & control , Hospitales de Enseñanza

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Introduction: Critically ill patients supported with venoarterial extracorporeal membrane oxygenation (VA ECMO) are at risk of developing severe arterial hyperoxia, which has been associated with increased mortality. Lower saturation targets in this population may lead to deleterious episodes of severe hypoxia. This manuscript describes the protocol and statistical analysis plan for the Blend to Limit OxygEN in ECMO: A RanDomised ControllEd Registry (BLENDER) Trial. Design: The BLENDER trial is a pragmatic, multicentre, registry-embedded, randomised clinical trial., registered at ClinicalTrials.gov (NCT03841084) and approved by The Alfred Hospital Ethics Committee project ID HREC/50486/Alfred-2019. Participants and setting: Patients supported by VA ECMO for cardiogenic shock or cardiac arrest who are enrolled in the Australian national ECMO registry. Intervention: The study compares a conservative oxygenation strategy (target arterial saturations 92-96%) with a liberal oxygenation strategy (target 97-100%). Main Outcome Measures: The primary outcome is the number of intensive care unit (ICU)-free days for patients alive at day 60. Secondary outcomes include duration of mechanical ventilation, ICU and hospital mortality, the number of hypoxic episodes, neurocognitive outcomes, and health economic analyses. The 300-patient sample size enables us to detect a 3-day difference in ICU-free days at day 60, assuming a mean ICU-free days of 11 days, with a risk of type 1 error of 5% and power of 80%. Data will be analysed according to a predefined analysis plan. Findings will be disseminated in peer-reviewed publications. Conclusions: This paper details the protocol and statistical analysis plan for the BLENDER trial, a registry-embedded, multicentre interventional trial comparing liberal and conservative oxygenation strategies in VA ECMO.