Chest
EditorialsPoint/Counterpoint EditorialsCounterpoint: Efficacy of Extracorporeal Membrane Oxygenation in 2009 Influenza A(H1N1): Sufficient Evidence?
Section snippets
Treatments Should Do More Good Than Harm
Ethical considerations demand convincing evidence that treatments produce more good than harm and that patients thus benefit overall from the applied treatment.15 The common practice of framing such treatments as “rescue” or “salvage” therapies raises ethical issues and risks biasing decisions and damaging the principle of autonomy (self-determination).15 Framing a therapeutic decision as a rescue or salvage treatment implies that the intervention offers the promise of well-known rescue
Treatment Decisions Should Be Based on Credible Evidence
The evidence-based clinical decision-making movement has produced widespread acceptance of the superiority of systematically acquired evidence over clinician opinion. This conclusion is based on many branches of study, including human short-term memory limitations, sources of decision-making bias, and the recognition that appearances can be deceiving.
The Most Credible Evidence Comes From Rigorous Experiments (eg, Clinical Trials)
A clear and explicit research protocol, a prerequisite for reproducibility of results, is required of all scientifically rigorous experiments.16, 17 Reproducibility, here, means detail at a level that achieves or approaches that necessary for closed-loop control of a device or system (see “Methods,” and Tables 2 and 3 in 9, 18, 19, respectively). A clear and explicit research protocol for the experimental intervention, as well as explicit patient selection criteria, are essential for the
Favorable Results From Efficacy Clinical Trials Should Precede Effectiveness or Pragmatic Clinical Trials
Efficacy clinical trials provide the most compelling clinical experimental evidence. Efficacy clinical trials are conducted in environments more favorable for conducting research and typically require sizable resources for each study subject.23 Effectiveness and pragmatic clinical trials are conducted under less favorable research environments with more limited resources for each study patient.17, 23 Internal validity is emphasized in efficacy clinical trials and external validity in
Credible and Compelling Evidence That ECLS Benefits Adults With Hypoxemic Respiratory Failure Due to A(H1N1) Influenza Is Lacking
Reports of ECMO for patients with A(H1N1) influenza have been retrospective and generally include demographic, treatment, and outcome data without detailed methods. The largest of those reports (Australia and New Zealand ECMO) described 68 patients undergoing ECMO among 194 patients with A(H1N1) who required mechanical ventilation.2 ICU mortality in the ECMO-treated group was 21%. The lack of a prospective and rigorous trial design limits their relevance to general application of ECMO to
Summary
We believe current evidence does not support the widespread or routine application of extracorporeal treatment to adults with severe hypoxemic respiratory failure, including that due to A(H1N1) influenza infection. We believe the best clinical trial data are those provided by the first two clinical trials in spite of the differences in treatment between current and past eras.8, 9 We conclude that the benefits of ECMO treatment in A(H1N1)-related hypoxemic lung failure are unproven and therefore
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Cited by (36)
Extracorporeal life support for adult cardiopulmonary failure
2015, Best Practice and Research: Clinical AnaesthesiologyCitation Excerpt :Several retrospective cohorts from the 2009–2010 H1N1 influenza experience demonstrated outcomes favoring the use of ECMO in patients with severe acute respiratory distress syndrome (ARDS) (median PaO2 to FiO2 ratio <60) [8–11]. However, the efficacy of ECMO in H1N1-related ARDS remains uncertain as patients with similar disease severity managed without ECMO had comparable outcomes in some studies [12–14]. Even after the H1N1 pandemic subsided, the use of ECMO support continued to rise, possibly spurred by the availability of a new dual-lumen cannula (Avalon Elite®, Maquet, Wayne, NJ, USA) as well as the results of the multicenter, randomized controlled trial comparing conventional ventilatory support versus ECMO for severe adult respiratory failure (CESAR) [15,16].
Effectiveness of extracorporeal membrane oxygenation when conventional ventilation fails: Valuable option or vague remedy?
2012, Journal of Critical CareCitation Excerpt :The increasing reports and reviews on successful use of ECMO in the 2009 H1N1 pandemic [31,36,39,40] were matched with reviews questioning the efficacy of ECMO in patients with severe respiratory failure [21,22,41]. Some argued that there is no evidence to support the use of ECMO [41]. Some argued for further probing into the acceptable physiologic end points and management thresholds in patients with severe ARDS such as ventilating with higher plateau pressures (>30 cm H2O) and accepting lower O2 saturations (80%) [22] instead of instituting ECMO.
Mechanical Ventilation in ARDS: Quo Vadis?
2022, Respiratory CareIndications for extracorporeal support: why do we need the results of the EOLIA trial?
2018, Medizinische Klinik - Intensivmedizin und NotfallmedizinTrends in Extracorporeal Membrane Oxygenation for the Treatment of Acute Respiratory Distress Syndrome in the United States
2017, Journal of Intensive Care Medicine
Financial/nonfinancial disclosures: The authors have reported to CHEST the following conflicts of interest: Dr Morris received grant monies from Agency for Health Care Policy and Research for the initial work. Dr Hite is a shareholder of Discover Laboratories and a member of the Data Safety and Monitoring Board, Cumberland Pharmaceuticals, 2006 to present. Drs Hirshberg, Miller, and Statler have reported to CHEST that no potential conflicts of interest exist with any companies/organizations whose products or services may be discussed in this article.
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