The New England Journal of Medicine JUNE 06, 2013

Prone Positioning in Severe Acute Respiratory Distress Syndrome

Claude Guérin, Jean Reignier, Jean-Christophe Richard, et al.

Bottom Line

The PROSEVA trial demonstrated that early and prolonged prone positioning significantly reduces 28-day mortality in patients with severe acute respiratory distress syndrome (ARDS) when implemented in experienced centers.

Key Findings

1. The primary endpoint of 28-day mortality was significantly lower in the prone-positioning group (16.0%) compared to the supine-positioning group (32.8%), with an adjusted hazard ratio of 0.39 (95% CI, 0.25 to 0.63; P<0.001).
2. At 90 days, mortality remained significantly lower in the prone-positioning group (23.6%) compared to the supine group (41.0%; P<0.001).
3. The prone-positioning group experienced higher rates of successful extubation (adjusted HR 1.69; P=0.003) and shorter time to successful extubation compared to the supine group.
4. Incidences of life-threatening complications, including cardiac arrest and selective main-stem intubation, did not differ significantly between the two groups.

Study Design

Design
RCT
Open-Label
Sample
466
Patients
Duration
90 days
Median
Setting
Multicenter, France/Spain
Population Intubated adult patients with severe ARDS, defined as a PaO2/FiO2 ratio <150 mmHg with an FiO2 >=0.6, PEEP >=5 cm H2O, and a tidal volume of approximately 6 mL/kg, persisting after a 12-24 hour stabilization period.
Intervention Prone positioning for at least 16 consecutive hours daily.
Comparator Standard supine positioning.
Outcome All-cause mortality at 28 days.

Study Limitations

The study was conducted in centers with extensive expertise (at least 5 years of experience) in prone positioning, which may limit the generalizability of these findings to centers with less experience.
The trial was open-label, meaning clinicians were aware of the treatment allocation, potentially introducing performance bias.
A large number of patients (n=2,121) assessed for eligibility were not randomized, suggesting a potential for selection bias.
Baseline imbalances existed between groups, such as differences in the use of neuromuscular blockers at enrollment.

Clinical Significance

The PROSEVA trial established prolonged prone positioning (at least 16 hours daily) as a life-saving, evidence-based standard of care for severe ARDS, challenging previous skepticism based on earlier, short-duration trials and significantly influencing modern critical care management protocols.

Historical Context

Prior to PROSEVA, prone positioning in ARDS was widely regarded as an oxygenation-improving maneuver but lacked mortality benefit in large-scale trials, largely attributed to shorter durations of proning and less standardized lung-protective ventilation, a paradigm shifted by this landmark study.

Guided Discussion

High-yield insights from every perspective

Med Student
Medical Student

Beyond simple oxygenation improvement, what is the primary mechanotransduction-related reason that prone positioning reduces mortality in patients with severe ARDS?

Key Response

Prone positioning facilitates a more uniform distribution of transpulmonary pressure and alveolar inflation. In the supine position, the weight of the heart and the ventral-to-dorsal pressure gradient lead to dorsal atelectasis and ventral overdistension. By homogenizing lung strain and reducing regional overinflation, prone positioning mitigates Ventilator-Induced Lung Injury (VILI), which is the leading cause of multi-organ failure in ARDS.

Resident
Resident

A patient with ARDS has a P/F ratio of 130 mmHg on a PEEP of 10 and FiO2 of 0.7. According to the PROSEVA protocol, what are the specific timing and duration requirements for implementing prone positioning to achieve the mortality benefit described?

Key Response

PROSEVA targeted patients with 'severe' ARDS (P/F < 150) after a stabilization period of 12 to 24 hours. The mortality benefit was associated with 'early' application and 'prolonged' sessions, specifically lasting at least 16 consecutive hours per day, rather than short intermittent bursts.

Fellow
Fellow

Previous trials of prone positioning (such as the Prone-Supine II study) failed to show a survival benefit. What specific refinements in the PROSEVA trial design likely accounts for the significant reduction in 28-day mortality?

Key Response

Key differences included the selection of a more severely ill cohort (P/F < 150 vs higher thresholds in earlier studies), a longer duration of prone sessions (16+ hours vs 7-8 hours), and the requirement that participating centers be highly experienced in the technique. This suggests that the 'dose' of prone positioning and the severity of lung injury are critical determinants of efficacy.

Attending
Attending

The PROSEVA trial showed a staggering absolute mortality reduction of 16% at 28 days. In an era of 'open lung' ventilation and high PEEP strategies, does the prone position act as a replacement for high PEEP or a synergistic adjunct, and how should this change bedside teaching?

Key Response

Prone positioning and PEEP work synergistically but via different mechanisms. While PEEP maintains alveolar recruitment, prone positioning improves the recruitment-to-inflation ratio and reduces the recruitability threshold. Bedside teaching should emphasize that prone positioning is a potent 'biotrauma' intervention that stabilizes the lung parenchyma rather than just a rescue maneuver for refractory hypoxemia.

Scholarly Review

Critical appraisal through the lens of expert reviewers and guideline development

PhD
PhD

The PROSEVA trial was stopped early by the data and safety monitoring board for efficacy. Critically evaluate how early termination affects the precision of the point estimate for the Hazard Ratio (0.39) and the risk of overestimating the treatment effect.

Key Response

Truncated trials are notorious for 'random highs' where the observed effect size is larger than the true population effect. With a Hazard Ratio of 0.39 and an extremely low p-value (<0.001), the effect is likely real, but the magnitude may be exaggerated. Future meta-analyses must account for this 'over-optimism' when pooling PROSEVA with smaller or non-significant trials.

Journal Editor
Journal Editor

Given that the clinical staff could not be blinded to the intervention (proning), what measures were taken in PROSEVA to mitigate observer bias, and how concerning is the lack of a standardized weaning protocol across centers for the primary endpoint?

Key Response

The primary endpoint was all-cause mortality, which is a 'hard' objective outcome less susceptible to observer bias than subjective measures like 'clinical improvement.' However, the lack of a strictly mandated weaning protocol across all centers could introduce bias in how long patients remained on ventilators, potentially confounding secondary outcomes like ventilator-free days.

Guideline Committee
Guideline Committee

The 2017 ATS/ESICM/SCCM Clinical Practice Guideline gives a 'Strong Recommendation' for prone positioning in severe ARDS based largely on PROSEVA. Should this recommendation remain 'Strong' if a center lacks the specific 'proning team' infrastructure utilized in the trial?

Key Response

The strength of the recommendation is tied to the evidence of benefit, but the quality of implementation is a safety concern. Guidelines should specify that the 16-hour/day protocol should be the standard of care for P/F < 150, but emphasize that centers must undergo rigorous training to avoid complications like unplanned extubation or pressure ulcers, which were notably low in the PROSEVA trial due to staff expertise.

Clinical Landscape

Noteworthy Related Trials

2001

Gattinoni et al.

n = 304 · NEJM

Tested

Prone positioning

Population

Patients with acute respiratory failure

Comparator

Supine positioning

Endpoint

6-month mortality

Key result: Prone positioning improved oxygenation but did not significantly reduce mortality in the overall study population.
2006

Mancebo et al.

n = 130 · AJRCCM

Tested

Prone positioning for at least 7 hours daily

Population

Patients with acute lung injury or ARDS

Comparator

Supine positioning

Endpoint

Mortality at ICU discharge

Key result: Prone positioning did not significantly decrease mortality compared to supine positioning in patients with ALI or ARDS.
2013

Guérin et al.

n = 466 · NEJM

Tested

Early prone positioning (at least 16 hours)

Population

Patients with severe ARDS (PaO2/FiO2 < 150 mmHg)

Comparator

Supine positioning

Endpoint

28-day mortality

Key result: Early application of prolonged prone positioning significantly reduced 28-day mortality in patients with severe ARDS.

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