Respiratory failure & ventilation
High-Flow Nasal Oxygen vs Noninvasive Ventilation in Patients With Acute Respiratory Failure: The RENOVATE Randomized Clinical Trial
Authors' conclusion
Compared with NIV, HFNO met prespecified criteria for noninferiority for the primary outcome of endotracheal intubation or death within 7 days in 4 of the 5 patient groups with ARF.
Study context
- Population
- Hospitalised adults with acute respiratory failure (ARF) in 5 groups (nonimmunocompromised with hypoxemia, immunocompromised with hypoxemia, COPD exacerbation with respiratory acidosis, ACPE, hypoxemic COVID-19), 33 hospitals in Brazil, 2019–20231,766 completed
- Participants
- 1,800 adults
- Comparison
- High-flow nasal oxygen (HFNO) vs noninvasive ventilation (NIV)
- HFNOn = 883
- NIVn = 883reference
- Primary endpoint
- Endotracheal intubation or death (noninferiority: posterior probability ≥0.992 for OR <1.55)
- Follow-up
- 7 days
Methodological detailsnoninferiority, multicentre, bayesian hierarchical model with dynamic borrowing
- Noninferiority
- Multicentre
- Bayesian hierarchical model with dynamic borrowing
Primary result
As reported in the abstract
Endotracheal intubation or death, by patient group (overall and 5 groups)
HFNO vs NIVOdds ratio (95% CrI)
Immunocompromised with hypoxemia: 57.1% (16/28) vs 36.4% (8/22); NPP 0.989; enrollment stopped for futility
1.07(0.81–1.39)
Nonimmunocompromised with hypoxemia: 32.5% (81/249) vs 33.1% (78/236); NPP 0.999
1.02(0.81–1.26)
ACPE: 10.3% (14/136) vs 21.3% (29/136); NPP 0.997
0.97(0.73–1.23)
Hypoxemic COVID-19: 51.3% (223/435) vs 47.0% (210/447); NPP 0.997
1.13(0.94–1.38)
COPD exacerbation with respiratory acidosis: 28.6% (10/35) vs 26.2% (11/42); NPP 0.992
1.05(0.79–1.36)
Dotted line: non-inferiority margin 0.992
Further findings
Post hoc analysis without dynamic borrowing
- Some qualitatively different results in COPD, immunocompromised and ACPE patients
- Post hoc
Safety
Serious adverse events
Serious adverse events
- Similar incidence
Original publication
High-Flow Nasal Oxygen vs Noninvasive Ventilation in Patients With Acute Respiratory Failure: The RENOVATE Randomized Clinical Trial. JAMA. Published 11 March 2025. doi:10.
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