High-flow nasal oxygen was found to be noninferior to noninvasive ventilation in reducing the rates of intubation or death within seven days in four of the five patient groups with acute respiratory failure, although the trial was halted for futility in the immunocompromised group, according to a recent study.
The RENOVATE randomized clinical trial, conducted between November 2019 and November 2023 (final follow-up: April 26, 2024), aimed to evaluate whether high-flow nasal oxygen (HFNO) was noninferior to noninvasive ventilation (NIV) in reducing the rates of endotracheal intubation or death within 7 days in patients with acute respiratory failure (ARF). The study, published in JAMA, enrolled 1,800 hospitalized adults from 33 Brazilian hospitals, with 1,766 completing the study. The participant population had a mean age of 64 years (SD, 17), and 40% were women. Participants were categorized into five ARF groups: nonimmunocompromised with hypoxemia, immunocompromised with hypoxemia, chronic obstructive pulmonary disease (COPD) exacerbation with respiratory acidosis, acute cardiogenic pulmonary edema (ACPE), and hypoxemic COVID-19. Patients were randomized to receive either HFNO (n=883) or NIV (n=883).
The primary outcome of endotracheal intubation or death at 7 days occurred in 39% (344/883) in the HFNO group versus 38% (336/883) in the NIV group. Noninferiority was defined by a posterior probability of ≥0.992 for an odds ratio <1.55. Using a Bayesian hierarchical model with dynamic borrowing across the groups, the study found that HFNO was noninferior to NIV in four of the five groups. In nonimmunocompromised patients with hypoxemia, the primary outcome occurred in 32.5% (81/249) of HFNO patients versus 33.1% (78/236) in the NIV group (odds ratio [OR], 1.02; 95% credible interval [CrI], 0.81-1.26; noninferiority posterior probability [NPP], 0.999). Among COPD patients with respiratory acidosis, rates were 28.6% (10/35) for HFNO versus 26.2% (11/42) for NIV (OR, 1.05; 95% CrI, 0.79-1.36; NPP, 0.992). In the ACPE group, rates were 10.3% (14/136) for HFNO versus 21.3% (29/136) for NIV (OR, 0.97; 95% CrI, 0.73-1.23; NPP, 0.997). In hypoxemic COVID-19 patients, rates were 51.3% (223/435) for HFNO versus 47.0% (210/447) for NIV (OR, 1.13; 95% CrI, 0.94-1.38; NPP, 0.997).
In the immunocompromised with hypoxemia group, the trial was halted early for futility after the primary outcome occurred in 57.1% (16/28) of HFNO patients versus 36.4% (8/22) of NIV patients (OR, 1.07; 95% CrI, 0.81-1.39; NPP, 0.989).
Secondary outcomes, including 28-day and 90-day mortality, showed no significant differences between the two groups. Serious adverse events were similar in both groups, occurring in 9.4% of HFNO patients versus 9.9% of NIV patients. Patient comfort was significantly better with HFNO.
A post hoc analysis without dynamic borrowing revealed some qualitatively different results in patients with COPD, immunocompromised patients, and patients with ACPE. The study authors noted that the small sample sizes in some patient groups and the sensitivity of findings to the choice of analysis model suggests the need for further study in these populations.
Full disclosures can be found in the published study.
