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15-01-2025 | Pulmonary Emergencies | Editor's Choice | News

High-flow nasal oxygen noninferior to noninvasive ventilation for intubation and death risk

Author: Matthew Williams

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medwireNews: The use of high-flow nasal oxygen (HFNO) is no worse than noninvasive ventilation (NIV) for preventing endotracheal intubation and death in patients with different causes of acute respiratory failure (ARF), say the RENOVATE trial investigators.

They compared the two treatment options in five groups of patients, including non-immunocompromised patients with hypoxemia, immunocompromised patients with hypoxemia, and patients with chronic obstructive pulmonary disease (COPD) exacerbation and respiratory acidosis, acute cardiogenic pulmonary edema (ACPE), or hypoxemic COVID-19, at 33 hospitals in Brazil.

The noninferiority of HFNO to NIV was consistent across all the groups, except for immunocompromised patients with hypoxemic acute respiratory failure, and enrolment to this group was stopped at the first interim analysis on the grounds of futility.

While NIV is the guideline-recommended option for patients with ARF due to COPD exacerbation and ACPE, the evidence supporting its use “is based on comparison with low-flow oxygen not [HFNO],” say the investigators in JAMA.

Meanwhile, “[HFNO] is preferred over low-flow oxygen for treating patients with hypoxemic acute respiratory failure, including those with immunosuppression or COVID-19,” they add. It also offers advantages such as “being easier to use and more comfortable for the patient.” However, it “may be less effective in reducing the workload on respiratory muscles during acute respiratory failure,” the investigators point out.  

For the study, Alexandre Biasi Cavalcanti (Hcor Research Institute, São Paulo, Brazil) and colleagues randomly assigned 1800 patients (mean age 64 years; 60% men) to receive HFNO (continuous flow starting at 30–45 mL, depending on ARF cause, and titrated to highest flow tolerated) or NIV (delivered via a facemask at an inspiratory positive airway pressure 12–16 cm of H2O and expiratory positive airway pressure 4 or 8 cm of H2O, depending on ARF group).

The patients had been admitted to hospital with ARF presenting as hypoxemia (oxygen saturation on pulse oximetry [SpO2] <90% or partial pressure of oxygen [PaO2] <60 mmHg) and either respiratory effort or tachypnea. With both treatments, the fraction of inspired oxygen was titrated to maintain an SpO2 of 88–92% for the COPD exacerbation patients and 92–98% for the other groups.

Of the 1766 participants who completed the study, 39% of the 883 patients in the HFNO group either required endotracheal intubation or died within 7 days, versus 38% of the 883 patients in the NIV group.

HFNO was noninferior to NIV for the outcome in four of the ARF groups, based on a noninferior posterior probability (NPP) greater than 0.992 and an odds ratio (OR) below 1.55.

Specifically, among the 785 non-immunocompromised patients with hypoxemia, the rates of endotracheal intubation or death at 7 days were 32.5% for the 249 treated with HFNO and 33.1% for the 236 treated with NIV (OR=1.02; NPP=0.999).

The rates for the 77 patients with COPD exacerbations with respiratory acidosis, who had a respiratory rate greater than 25 breaths/min or used accessory musculature, and had paradoxical breathing and thoracoabdominal asynchrony; or had an arterial blood pH level lower than 7.35 and a PaCO2 level greater than 45 mmHg, were 28.6% among 35 treated with HFNO and 26.2% among 42 treated with NIV (OR=1.05; NPP=0.992).

In patients with ACPE (ie, sudden-onset dyspnea and diffuse crackling rales; no pulmonary aspiration, fibrosis or infection; ACPE as the primary clinical hypothesis; or a chest X-ray with bilateral alveolar infiltrates suggestive of pulmonary edema, a respiratory rate greater than 25 breaths/min, and SpO2 <95%), 10.3% of 136 HFNO-treated patients experienced the combined outcome versus 21.3% of 136 patients in the NIV group (OR=0.97; NPP= 0.997).

And in COVID-19 patients with hypoxemia the combined outcome occurred in 51.3% versus 47.0% of 435 HNFO- and 447 NIV-treated patients, respectively (OR=1.13; NPP=0.997).

In a related editorial, Yonathan Freund and Amelie Vromant, both from Assistance Publique – Hôpitaux de Paris in France, highlight that “[t]he substantial sample sizes in the hypoxemic and COVID-19 patient groups reinforce the conclusion of the noninferiority of [HFNO], which is useful clinical information because current evidence has not resulted in a recommendation of [HFNO] in these patients.”

Conversely, they flag the need for caution in considering the smaller samples of COPD and acute heart failure patients.

The editorialists also note that the noninferiority margin of an OR of 1.55 “[f]or a composite outcome as consequential as endotracheal intubation or death, […] could represent a substantial risk tolerance,” adding that “a tighter margin may have offered a clearer view of the comparative safety and effectiveness of [HFNO].”

They conclude that further research is required, including trials that prioritize the patient comfort benefits offered by HFNO, and weigh up the “procedural complexity and resource demands” of HFNO compared with “the accessibility of noninvasive ventilation.”

medwireNews is an independent medical news service provided by Springer Healthcare Ltd. © 2025 Springer Healthcare Ltd, part of the Springer Nature Group

JAMA 2024; doi:10.1001/jama.2024.26244
JAMA 2024; doi:10.1001/jama.2024.25869

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