NCT03643939: RENOVATE

High-Flow Nasal Oxygen Cannula Compared to Non-Invasive Ventilation in Adult Patients With AcuTE Respiratory Failure

Completed NA Last updated 20 May 2024

What this trial tests

NA trial testing High Flow Nasal Catheter in Respiratory Insufficiency in 1,801 participants. Completed in 28 February 2024.

Timeline

1 November 2019

Primary endpoint
30 November 2023

28 February 2024

Quick facts

Lead sponsor	Hospital do Coracao
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	1,801
Start date	1 November 2019
Primary completion	30 November 2023
Estimated completion	28 February 2024
Sites	1 location across Brazil

Drugs / interventions tested

• High Flow Nasal Catheter
• Noninvasive ventilation

Conditions studied

• Respiratory Insufficiency — all drugs for Respiratory Insufficiency →
• Respiratory Failure — all drugs for Respiratory Failure →

Sponsor

Hospital do Coracao

Who can join

18 and older, any sex, with Respiratory Insufficiency or Respiratory Failure. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

RENOVATE study aims to investigate if the respiratory support device called High-Flow Nasal Oxygen Cannula (HFNC) acts similarly (non-inferior) to another respiratory support device called Non-Invasive positive-pressure Ventilation (NIPPV) in preventing endotracheal intubation in adult patients with Acute Respiratory Failure (ARF) from different causes. HFNC is a somewhat new method of respiratory support in adults that has been used in neonatal ARF for some years. The reason this study is necessary is that, even though NIPPV has been demonstrated to prevent endotracheal intubation (and its associated complications) in a broad range of ARF patients, HFNC has been proposed to have the same beneficial effect of NIPPV while being easier tolerated, allowing patients to talk, eat and drink through mouth while on HFNC. RENOVATE will recruit between 800 to 2000 patients (adaptive design) with different types of ARF in Brazil. Patients will be randomized to HFNC or NIPPV and the rate of endotracheal intubation will be compared between groups as well as other parameters such as vital status and other health care related complications.

\[IMPORTANT NOTE\] On April 13, 2021, on the first interim analysis, the DSMB recommended the interruption of the immunocompromised hypoxemic ARF subgroup.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. High-flow nasal cannulae for respiratory support in adult intensive care patients.
   Corley A, Rickard CM, Aitken LM, Johnston A, et al · · 2017 · cited 44× · PMID 28555461 · DOI 10.1002/14651858.cd010172.pub2
2. High-flow nasal cannulae for respiratory support in adult intensive care patients.
   Lewis SR, Baker PE, Parker R, Smith AF. · · 2021 · cited 43× · PMID 33661521 · DOI 10.1002/14651858.cd010172.pub3
3. High-Flow Nasal Oxygen vs Noninvasive Ventilation in Patients With Acute Respiratory Failure: The RENOVATE Randomized Clinical Trial.
   RENOVATE Investigators and the BRICNet Authors, Maia IS, Kawano-Dourado L, Tramujas L, et al · · 2025 · cited 35× · PMID 39657981 · DOI 10.1001/jama.2024.26244
4. High flow nasal catheter therapy versus non-invasive positive pressure ventilation in acute respiratory failure (RENOVATE trial): protocol and statistical analysis plan.
   Maia IS, Kawano-Dourado L, Zampieri FG, Damiani LP, et al · · 2022 · cited 7× · PMID 38046839 · DOI 10.51893/2022.1.oa8
5. Update in statistical analysis plan of the RENOVATE trial.
   Maia IS, Kawano-Dourado L, Damiani LP, Fitzgerald M, et al · · 2023 · cited 2× · PMID 37876375 · DOI 10.1016/j.ccrj.2023.06.008
6. Brazilian Research in Intensive Care Network (BRICNet): shaping the landscape of critical care research in Brazil and beyond.
   Ferreira JC, Pereira AJ, Pereira AJ, Cavalcanti AB, et al · · 2025 · cited 1× · PMID 40561345 · DOI 10.62675/2965-2774.20250284
7. Sequential likelihood ratios and e-processes in the analysis of the RENOVATE trial.
   Zampieri FG, Cavalcanti AB, Cahusac PMB, Kawano-Dourado L, et al · · 2026 · PMID 41734013 · DOI 10.1093/annalsats/aaoag042
8. Supportive Care in Patients with Critical Coronavirus Disease 2019.
   Sweeney DA, Malhotra A. · · 2022 · PMID 36328636 · DOI 10.1016/j.idc.2022.08.003