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evident
Original paper
2019NEJMPulmonary/Critical Care

ROSE

Early neuromuscular blockade in the acute respiratory distress syndrome

RCTARDS

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Overview

Routine early paralysis did not improve mortality versus lighter sedation in moderate-severe ARDS.

Clinical takeaway

ROSE tempered ACURASYS by showing no mortality benefit to routine early cisatracurium when compared with a modern lighter-sedation, high-PEEP strategy.

Key result

In-hospital death at 90 days was 42.5% with early cisatracurium vs 42.8% with usual care (difference -0.3 percentage points; 95% CI -6.4 to 5.9; P=0.93).

Practice impact

Reserve paralysis for selected ARDS problems rather than routine early use.

Evidence

Study design

Randomized open-label trial stopped early for futility.

Enrollment

1,006

Follow-up

90 days.

Geography

United States

Clinical question

Does early continuous neuromuscular blockade improve mortality in moderate-severe ARDS compared with usual care with lighter sedation?

Population

  • Adults with moderate-to-severe ARDS on mechanical ventilation.

Intervention

48-hour cisatracurium infusion with deep sedation.

Comparator

Usual care approach with lighter sedation targets and no routine paralysis.

Primary outcome

In-hospital death from any cause at 90 days.

Routine early neuromuscular blockade did not improve 90-day in-hospital mortality.

Absolute difference (percentage points) / -0.3 / 95% CI -6.4 to 5.9 / p=0.93

Key results

  • 90-day in-hospital mortality did not differ significantly: 42.5% with cisatracurium vs 42.8% with usual care (difference -0.3 percentage points; 95% CI -6.4 to 5.9; p=0.93).
  • The trial was stopped early for futility.
  • Cardiovascular adverse events were more common in the intervention group.

Harms

  • Deep sedation and paralysis increase immobility and monitoring burden.
  • Cardiovascular adverse events were more common with the intervention strategy.

Clinical Use

Practice impact

  • Reduced enthusiasm for routine early paralysis in all moderate-severe ARDS patients.

Applicability

  • Modern ventilated ARDS patients managed with lung-protective ventilation and lighter sedation practices.

Limitations

  • Open-label design.
  • Does not exclude rescue paralysis for severe dyssynchrony or refractory hypoxemia.

Common misinterpretations

  • ROSE does not ban neuromuscular blockers; it argues against routine early continuous infusion for everyone.

Related evidence

ACURASYS - Contrasting ResultPROSEVA - Context

Citation

National Heart, Lung, and Blood Institute PETAL Clinical Trials Network, Moss M, Huang DT, et al. Early Neuromuscular Blockade in the Acute Respiratory Distress Syndrome. N Engl J Med. 2019;380(21):1997-2008. doi:10.1056/NEJMoa1901686

Among patients with moderate-to-severe ARDS who were treated with a strategy involving a high PEEP, there was no significant difference in mortality at 90 days between patients who received an early and continuous cisatracurium infusion and those who were treated with a usual-care approach with lighter sedation targets.