The RENOVATE Randomized Clinical Trial (JAMA, 2024)

High-flow Nasal Oxygen vs. Noninvasive Ventilation in Patients with Acute Respiratory Failure


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Trial summary

The rate of endotracheal intubation or mortality within seven days of using high-flow nasal oxygen (HFNO) was
non-inferior to noninvasive ventilation (NIV) in four of the five patient groups with acute respiratory failure (ARF).


Patient groups (n = 1766) 

  • Non-immunocompromised with hypoxemia (non-inferior)  
  • AECOPD with respiratory acidosis (non-inferior)  
  • Acute cardiogenic pulmonary edema (non-inferior)  
  • Hypoxemic COVID-19 (non-inferior)  
  • Immunocompromised with hypoxemia (stopped due to futility)  


HFNO was found to be significantly more comfortable than NIV across the entire study population.




Key takeaways 


  • This research demonstrates that HFNO is non-inferior to NIV for most causes of ARF and is significantly more comfortable for patients.



  • Building on the existing body of literature and numerous clinical practice guidelines that recommend HFNO, these insights could significantly advance the management of patients with ARF.



  • These broad findings may be particularly useful in settings where patients initially present, such as the Emergency Department (ED). 



  • Notably, 32% of HFNO initiation in the RENOVATE study took place in the ED.


HFNO may be considered a safe and effective first-line and/or bridge therapy, providing time to: 


  • Establish the diagnosis and underlying cause of respiratory failure. 



  • Select the most suitable form of treatment, which might include continuing with HFNO or transitioning to a different form of respiratory support.

“These results suggest that high flow oxygen can serve as a safe-bridge therapy while the underlying cause of acute respiratory failure is determined, and the most appropriate respiratory support is ultimately implemented.”

Jean-Pierre Frat, MD, PhD; Sylvain Le Pape, MD, PhD & Arnaud W. Thille, MD, PhD (JAMA editorial, 2024)




RENOVATE study: High-Flow Nasal Oxygen vs. Noninvasive Ventilation in Patients with Acute Respiratory Failure. RENOVATE: The Randomized Clinical Trial. JAMA, December 2024 View abstract

Frat, Le Pape & Thille, JAMA editorial:
Is high-flow nasal oxygen the standard for patients with acute respiratory conditions? JAMA, December 10, 2024
View editorial

Freund & Vromant, JAMA editorial:
Re-evaluating Respiratory Support in Acute Respiratory Failure. Insights from the RENOVATE Trial and Implications for Practice. JAMA, December 10, 2024 View editorial 

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F&P and Optiflow are trademarks of Fisher & Paykel Healthcare Limited. For patent information, see www.fphcare.com/ip

Fisher & Paykel Healthcare provided equipment for the RENOVATE Randomized Clinical Trial.
Dr Frat has received grants from Fisher & Paykel Healthcare.