Burrell Aidan, Ng Sze, Ottosen Kelly, Bailey Michael, Buscher Hergen, Fraser John, Udy Andrew, Gattas David, Totaro Richard, Bellomo Rinaldo, Forrest Paul, Martin Emma, Reid Liadain, Ziegenfuss Marc, Eastwood Glenn, Higgins Alisa, Hodgson Carol, Litton Edward, Nair Priya, Orford Neil, Pellegrino Vince, Shekar Kiran, Trapani Tony, Pilcher David
Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University, Melbourne, VIC, Australia.
Department of Intensive Care and Hyperbaric Medicine, The Alfred, Melbourne, VIC, Australia.
Crit Care Resusc. 2023 Aug 4;25(3):118-125. doi: 10.1016/j.ccrj.2023.06.001. eCollection 2023 Sep.
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.
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.
Patients supported by VA ECMO for cardiogenic shock or cardiac arrest who are enrolled in the Australian national ECMO registry.
The study compares a conservative oxygenation strategy (target arterial saturations 92-96%) with a liberal oxygenation strategy (target 97-100%).
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.
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.
接受静脉-动脉体外膜肺氧合（VA ECMO）支持的重症患者有发生严重动脉血氧过高的风险，这与死亡率增加有关。该人群中较低的饱和度目标可能会导致严重缺氧的有害发作。本文描述了“在ECMO中混合以限制氧合：一项随机对照注册研究”（BLENDER）试验的方案和统计分析计划。
BLENDER试验是一项务实的、多中心的、注册登记式的随机临床试验，已在ClinicalTrials.gov注册（NCT03841084），并获得阿尔弗雷德医院伦理委员会批准（项目ID HREC/50486/Alfred - 2019）。
纳入澳大利亚国家ECMO注册登记的、接受VA ECMO支持的心源性休克或心脏骤停患者。
该研究将保守氧合策略（目标动脉饱和度92 - 96%）与宽松氧合策略（目标97 - 100%）进行比较。
主要结局是第60天时存活患者的无重症监护病房（ICU）天数。次要结局包括机械通气时间、ICU和医院死亡率、缺氧发作次数、神经认知结局以及卫生经济学分析。300例患者的样本量使我们能够检测出第60天时无ICU天数的3天差异，假设平均无ICU天数为11天，I型错误风险为5%，检验效能为80%。数据将根据预定义的分析计划进行分析。研究结果将在同行评审的出版物上发表。
本文详细介绍了BLENDER试验的方案和统计分析计划，这是一项注册登记式的多中心干预试验，比较了VA ECMO中宽松和保守氧合策略。
