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A Randomized Controlled Trial

Alain Mercat, MD; Jean-Christophe M. Richard, MD; Bruno Vielle, MD; Samir Jaber, MD; David Osman, MD; Jean-Luc Diehl, MD; Jean-Yves Lefrant, MD; Gwenaël Prat, MD; Jack Richecoeur, MD; Ania Nieszkowska, MD; Claude Gervais, MD; Jérôme Baudot, MD; Lila Bouadma, MD; Laurent Brochard, MD; for the Expiratory Pressure (Express) Study Group

JAMA. 2008;299(6):646-655.

Context  The need for lung protection is universally accepted, but the optimal level of positive end-expiratory pressure (PEEP) in patients with acute lung injury (ALI) or acute respiratory distress syndrome remains debated.

Objective  To compare the effect on outcome of a strategy for setting PEEP aimed at increasing alveolar recruitment while limiting hyperinflation to one aimed at minimizing alveolar distension in patients with ALI.

Design, Setting, and Patients  A multicenter randomized controlled trial of 767 adults (mean [SD] age, 59.9 [15.4] years) with ALI conducted in 37 intensive care units in France from September 2002 to December 2005.

Intervention  Tidal volume was set at 6 mL/kg of predicted body weight in both strategies. Patients were randomly assigned to a moderate PEEP strategy (5-9 cm H₂O) (minimal distension strategy; n = 382) or to a level of PEEP set to reach a plateau pressure of 28 to 30 cm H₂O (increased recruitment strategy; n = 385).

Main Outcome Measures  The primary end point was mortality at 28 days. Secondary end points were hospital mortality at 60 days, ventilator-free days, and organ failure–free days at 28 days.

Results  The 28-day mortality rate in the minimal distension group was 31.2% (n = 119) vs 27.8% (n = 107) in the increased recruitment group (relative risk, 1.12 [95% confidence interval, 0.90-1.40]; P = .31). The hospital mortality rate in the minimal distension group was 39.0% (n = 149) vs 35.4% (n = 136) in the increased recruitment group (relative risk, 1.10 [95% confidence interval, 0.92-1.32]; P = .30). The increased recruitment group compared with the minimal distension group had a higher median number of ventilator-free days (7 [interquartile range {IQR}, 0-19] vs 3 [IQR, 0-17]; P = .04) and organ failure–free days (6 [IQR, 0-18] vs 2 [IQR, 0-16]; P = .04). This strategy also was associated with higher compliance values, better oxygenation, less use of adjunctive therapies, and larger fluid requirements.

Conclusions  A strategy for setting PEEP aimed at increasing alveolar recruitment while limiting hyperinflation did not significantly reduce mortality. However, it did improve lung function and reduced the duration of mechanical ventilation and the duration of organ failure.

Trial Registration  clinicaltrials.gov Identifier: NCT00188058

Author Affiliations: Département de Réanimation Médicale et Médecine Hyperbare, CHU d’Angers, Angers, France (Dr Mercat); Service de Réanimation Médicale et UPRES EA 38-30, CHU de Rouen (Dr Richard); Service de Biostatistiques et Modélisation Informatique, CHU d’Angers (Dr Vielle); Service d’Anesthésie-Réanimation B, CHU de Montpellier (Dr Jaber); Service de Réanimation Médicale, Assistance Publique–Hôpitaux de Paris, CHU de Bicêtre (Dr Osman); Service de Réanimation Médicale, Hôpital Européen Georges Pompidou, Assistance Publique–Hôpitaux de Paris (Dr Diehl); Division Anesthésie Réanimation Douleur Urgences, Unités de Réanimation Chirurgicale et Médicale, CHU de Nîmes (Drs Lefrant and Gervais); Service de Réanimation Médicale, CHU de Brest (Dr Prat); Service de Réanimation Polyvalente, CH de Pontoise (Dr Richecoeur); Service de Réanimation Médicale, CHU Pitié-Salpétrière, Assistance Publique–Hôpitaux de Paris (Dr Nieszkowska); Service de Réanimation Polyvalente, CH de Nevers (Dr Baudot); Service de Réanimation Médicale, CHU Bichat-Claude Bernard, Assistance Publique–Hôpitaux de Paris (Dr Bouadma); and Service de Réanimation Médicale, CHU Henri Mondor, Assistance Publique–Hôpitaux de Paris, Créteil, INSERM Unit 841 et Université Paris 12 (Dr Brochard).

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