LandmarkRCT

ROSE

Early Neuromuscular Blockade in the Acute Respiratory Distress Syndrome

New England Journal of Medicine, 2019 · Multicenter, randomized controlled trial, unblinded, stopped early for futility

Clinical question

Does routine early continuous neuromuscular blockade improve survival in moderate-to-severe ARDS, compared with a lighter-sedation strategy?

Population: 1006 patients with moderate-to-severe ARDS (PaO2/FiO2 < 150) at North American centers.
Inclusion criteria: Moderate-to-severe ARDS: PaO2/FiO2 < 150.
Onset within the preceding 48 hours.
Intervention: Early continuous cisatracurium plus deep sedation for 48 hours.
Comparator: A lighter-sedation strategy, with neuromuscular blockade used only as needed for dyssynchrony or refractory hypoxemia.
Primary outcome: 90-day all-cause mortality.
Secondary outcomes: Ventilator-free days.
ICU-acquired weakness.
Result: Routine early continuous paralysis showed no mortality benefit over a lighter-sedation, as-needed approach, and the trial was stopped early for futility. (42.5% vs 42.8% 90-day mortality, p = 0.93)

What the trial found

In a larger, more contemporary trial using lighter background sedation in the comparator arm, routine early continuous neuromuscular blockade did not reduce mortality in moderate-to-severe ARDS.

Current guideline position

There is no strong formal recommendation for routine early paralysis; ROSE is the more contemporary and larger trial, and current practice generally follows it over ACURASYS.

Clinical interpretation

ROSE shifted practice away from routine early paralysis for all patients with severe ARDS; current guidance favors reserving neuromuscular blockade for patients with severe ventilator dyssynchrony or refractory hypoxemia despite adequate sedation, rather than applying it by default.

Limitations

The comparator arm used a lighter-sedation strategy than ACURASYS's comparator, so the trials are not directly testing the same clinical question.
Stopped early for futility, which can sometimes overestimate the null result.

High certainty

Clinical Context & Relevant Topics (1)

Disease Reference

Acute Respiratory Distress Syndrome

Acute, diffuse inflammatory lung injury causing hypoxemia and bilateral infiltrates not fully explained by cardiac failure or fluid overload.

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