Skip to main content
Top
Published in: Intensive Care Medicine 6/2014

01-06-2014 | Editorial

Clinical trials in patients with the acute respiratory distress syndrome: Burn after reading

Authors: Jesús Villar, Robert M. Kacmarek, Claude Guérin

Published in: Intensive Care Medicine | Issue 6/2014

Login to get access

Excerpt

Burn After Reading is a film written and directed by the Coen brothers which was released in 2008 (http://​en.​wikipedia.​org/​wiki/​Burn_​After_​Reading). The plot is seemingly without direction and is based upon computer files, medical records, numerical data, money, exchange of information, and erratic behaviors. Everything ends badly. Analysts of the Central Intelligence Agency made attempts to understand what really happened in the film and concluded that although individually everything sounded important, as a whole everything was meaningless. This is exactly how we feel after reading the review by Tonelli et al. [1] of 159 randomized controlled trials (RCTs) and 29 meta-analyses of trials in patients with acute respiratory distress syndrome (ARDS). On first glance this review appeared to be an excellent summary of ARDS research which we, as clinicians involved in the field, were very keen to read, but which ultimately left us still looking for more. After 25 years and hundreds of millions of euros/dollars of clinical research funding, only three specific interventions have been found that can decrease ARDS mortality, namely, the use of low tidal volumes, prone positioning, and neuromuscular blockade early in the course of severe ARDS. According to Tonelli et al., the survival benefit of these specific interventions has only been demonstrated in a single RCT for each intervention [24], without any further validation or confirmatory trial. …
Literature
1.
go back to reference Tonelli AR, Zein J, Adams J, Ioannidis JPA (2014) Effects of interventions on survival in acute respiratory distress syndrome: an umbrella review of 159 published randomized trials and 29 meta-analyses. Intensive Care Med. doi:10.1007/s00134-014-3272-1 PubMed Tonelli AR, Zein J, Adams J, Ioannidis JPA (2014) Effects of interventions on survival in acute respiratory distress syndrome: an umbrella review of 159 published randomized trials and 29 meta-analyses. Intensive Care Med. doi:10.​1007/​s00134-014-3272-1 PubMed
2.
go back to reference The Acute Respiratory Distress Syndrome Network (2000) Ventilation with lower tidal volumes as compared with traditional tidal volumes for acute lung injury and the acute respiratory distress syndrome. N Engl J Med 342:1301–1318CrossRef The Acute Respiratory Distress Syndrome Network (2000) Ventilation with lower tidal volumes as compared with traditional tidal volumes for acute lung injury and the acute respiratory distress syndrome. N Engl J Med 342:1301–1318CrossRef
3.
go back to reference Papazian L, Forel JM, Gacouin A, Penot-Ragon C, Perrin G, Loundou A et al (2010) Neuromuscular blockers in early acute respiratory distress syndrome. N Engl J Med 363:1107–1116PubMedCrossRef Papazian L, Forel JM, Gacouin A, Penot-Ragon C, Perrin G, Loundou A et al (2010) Neuromuscular blockers in early acute respiratory distress syndrome. N Engl J Med 363:1107–1116PubMedCrossRef
4.
go back to reference Guerin C, Reignier J, Richard JC, Beuret P, Gacoiun A, Boulain T et al (2013) Prone positioning in severe acute respiratory distress syndrome. N Engl J Med 368:2159–2168PubMedCrossRef Guerin C, Reignier J, Richard JC, Beuret P, Gacoiun A, Boulain T et al (2013) Prone positioning in severe acute respiratory distress syndrome. N Engl J Med 368:2159–2168PubMedCrossRef
5.
go back to reference Villar J, Pérez-Méndez L, López J, Belda J, Blanco J, Saralegui I et al (2007) An early PEEP/FiO2 trial identifies different degrees of lung injury in patients with the acute respiratory distress syndrome. Am J Respir Crit Care Med 176:795–804PubMedCrossRef Villar J, Pérez-Méndez L, López J, Belda J, Blanco J, Saralegui I et al (2007) An early PEEP/FiO2 trial identifies different degrees of lung injury in patients with the acute respiratory distress syndrome. Am J Respir Crit Care Med 176:795–804PubMedCrossRef
6.
go back to reference Villar J, Pérez-Méndez L, Blanco J, Añón JM, Blanch L, Belda J et al (2013) A universal definition of ARDS: the PaO2/FiO2 ratio under a standard ventilatory setting: a prospective, multicenter validation study. Intensive Care Med 39:583–592PubMedCrossRef Villar J, Pérez-Méndez L, Blanco J, Añón JM, Blanch L, Belda J et al (2013) A universal definition of ARDS: the PaO2/FiO2 ratio under a standard ventilatory setting: a prospective, multicenter validation study. Intensive Care Med 39:583–592PubMedCrossRef
7.
go back to reference Hernu R, Wallet F, Thiollière F, Martin O, Richard JC, Schmitt Z et al (2013) An attempt to validate the modification of the American-European consensus definition of acute lung injury/acute respiratory distress syndrome by the Berlin definition in a university hospital. Intensive Care Med 39:2161–2170PubMedCrossRef Hernu R, Wallet F, Thiollière F, Martin O, Richard JC, Schmitt Z et al (2013) An attempt to validate the modification of the American-European consensus definition of acute lung injury/acute respiratory distress syndrome by the Berlin definition in a university hospital. Intensive Care Med 39:2161–2170PubMedCrossRef
8.
go back to reference Caser EB, Zandonade E, Pereira E, Casati-Gama AM, Barbas CSV (2014) Impact of distinct definitions of acute lung injury on its incidence and outcomes in Brazilian ICUs: prospective evaluation of 7,133 patients. Crit Care Med 42:574–582PubMedCrossRef Caser EB, Zandonade E, Pereira E, Casati-Gama AM, Barbas CSV (2014) Impact of distinct definitions of acute lung injury on its incidence and outcomes in Brazilian ICUs: prospective evaluation of 7,133 patients. Crit Care Med 42:574–582PubMedCrossRef
9.
go back to reference Villar J, Pérez-Méndez L, Aguirre-Jaime A, Kacmarek RM (2005) Why are physicians so sceptical about positive randomized controlled clinical trials in critical care medicine? Intensive Care Med 31:196–204PubMedCrossRef Villar J, Pérez-Méndez L, Aguirre-Jaime A, Kacmarek RM (2005) Why are physicians so sceptical about positive randomized controlled clinical trials in critical care medicine? Intensive Care Med 31:196–204PubMedCrossRef
10.
go back to reference De Duve C (2013) Sur la science et au-delà. Odile Jacob Science, Paris De Duve C (2013) Sur la science et au-delà. Odile Jacob Science, Paris
Metadata
Title
Clinical trials in patients with the acute respiratory distress syndrome: Burn after reading
Authors
Jesús Villar
Robert M. Kacmarek
Claude Guérin
Publication date
01-06-2014
Publisher
Springer Berlin Heidelberg
Published in
Intensive Care Medicine / Issue 6/2014
Print ISSN: 0342-4642
Electronic ISSN: 1432-1238
DOI
https://doi.org/10.1007/s00134-014-3288-6

Other articles of this Issue 6/2014

Intensive Care Medicine 6/2014 Go to the issue