Do we need randomized clinical trials in extracorporeal respiratory support? No

Veno-venous extracorporeal membrane oxygenation in acute respiratory distress syndrome: should the EOLIA Study results change our clinical approach?

“…13 Should we perhaps plan another ECMO RCT? The chances for a meaningful result from a RCT comparing ECMO as a rescue procedure versus conventional mechanical ventilation are very low, and the difficulties involved almost insurmountable, as discussed recently by Gattinoni et al 14 This does not mean that such a study would not be desirable, but simply that it is almost impossible to perform. We strongly believe that for time being and as we do with other rescue procedures, we should be content with the evidence we have.…”

Focus on extracorporeal life support

“…"Advocators" of RCTs argue that the highest level of evidence must be sought in high-risk and resource-intense techniques such as ECLS, as alternative designs, including observational studies, are at significant risk of confounding by indication and residual confounding [5]. On the other side, *Correspondence: mortenhylander@gmail.com 5 Department of Intensive Care 4131, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark Full author information is available at the end of the article "sceptics" argue that, under rescue conditions, including acute life-threatening hypoxia or refractory cardiogenic shock, potentially life-saving interventions should not be prone to randomization due to ethical reasons and lack of equipoise [3]. Furthermore, clinically relevant and realistic treatment effects would necessitate larger sample sizes than in ongoing and existing ECLS trials, which would likely be challenging within a reasonable time frame [3].…”

“…On the other side, *Correspondence: mortenhylander@gmail.com 5 Department of Intensive Care 4131, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark Full author information is available at the end of the article "sceptics" argue that, under rescue conditions, including acute life-threatening hypoxia or refractory cardiogenic shock, potentially life-saving interventions should not be prone to randomization due to ethical reasons and lack of equipoise [3]. Furthermore, clinically relevant and realistic treatment effects would necessitate larger sample sizes than in ongoing and existing ECLS trials, which would likely be challenging within a reasonable time frame [3]. Eventually, variabilities concerning ECLS techniques, overall management, centers, and different patient populations may furthermore hamper the interpretation of results derived from RCTs [4], according to "sceptics".…”

“…This focus editorial embraces a series of recent publications on extracorporeal life support (ECLS), including state-of-the-art reviews [1], areas of uncertainties [2], challenges in producing clinical evidence [3][4][5], as well as ethical considerations [6]. Finally, the recent EOLIA trial on the use of veno-venous extracorporeal membrane oxygenation (VV-ECMO) in patients with severe acute respiratory distress syndrome (ARDS) is discussed [7].…”

Use of ECMO in ARDS: does the EOLIA trial really help?

“…These results will split clinicians into believers and non-believers, and may prompt a request for another high-quality RCT. It is our strong belief that this is simply not possible [5].…”