RENOVATE
Trial question
Is high-flow nasal oxygen noninferior to noninvasive ventilation in patients with acute respiratory failure?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
40.0% female
60.0% male
N = 1766
1766 patients (707 female, 1059 male).
Inclusion criteria: adult patients with acute respiratory failure.
Key exclusion criteria: urgent need for endotracheal intubation; hemodynamic instability; contraindications to noninvasive ventilation.
Interventions
N=883 high-flow nasal oxygen (delivered through Airvo™ 2 allowing adjustable FiO2 from 21-100% and delivering flow up to 60 L/min).
N=883 noninvasive ventilation (delivered through a facial mask using either a ventilator designed primarily for invasive or noninvasive ventilation).
Primary outcome
Endotracheal intubation or death at 7 days in nonimmunocompromised patients with hypoxemia
32.5%
33.1%
33.1 %
24.8 %
16.6 %
8.3 %
0.0 %
High-flow nasal
oxygen
Noninvasive
ventilation
Difference not exceeding
non-inferiority
margin ✓
Difference not exceeding non-inferiority margin in endotracheal intubation or death at 7 days in nonimmunocompromised patients with hypoxemia (32.5% vs. 33.1%; OR 1.02, 95% CI 0 to 2.04).
Secondary outcomes
No significant difference in endotracheal intubation or death at 7 days in patients with hypoxemia due to COVID-19 infection (51.3% vs. 47%; OR 1.13, 95% CI 0 to 2.26).
Safety outcomes
No significant difference in serious adverse events.
Conclusion
In adult patients with acute respiratory failure, high-flow nasal oxygen was noninferior to noninvasive ventilation with respect to endotracheal intubation or death at 7 days in nonimmunocompromised patients with hypoxemia.
Reference
RENOVATE Investigators and the BRICNet Authors, Israel S Maia, Letícia Kawano-Dourado et al. High-Flow Nasal Oxygen vs Noninvasive Ventilation in Patients With Acute Respiratory Failure: The RENOVATE Randomized Clinical Trial. JAMA. 2025 Mar 11;333(10):875-890.
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