IMPORTANCE: High-flow nasal oxygen therapy is increasingly used for acute hypoxemic respiratory failure (AHRF). OBJECTIVE: To determine whether high-flow oxygen therapy decreases mortality among immunocompromised patients with AHRF compared with standard oxygen therapy. DESIGN, SETTING, AND PARTICIPANTS: The HIGH randomized clinical trial enrolled 776 adult immunocompromised patients with AHRF (PaO2 < 60 mmHg or SpO2 < 90% on room air, or tachypnea > 30/min or labored breathing or respiratory distress, and need for oxygen >= 6 L/min) at 32 intensive care units (ICUs) in France between May 19, 2016, and December 31, 2017. INTERVENTIONS: Patients were randomized 1:1 to continuous high-flow oxygen therapy (n = 388) or to standard oxygen therapy (n = 388). MAIN OUTCOMES AND MEASURES: The primary outcome was day-28 mortality. Secondary outcomes included intubation and mechanical ventilation by day 28, PaO2:FiO2 ratio over the 3 days after intubation, respiratory rate, ICU and hospital lengths of stay, ICU-acquired infections, and patient comfort and dyspnea. RESULTS: Of 778 randomized patients (median age, 64 (IQR 54 to 71) years; 259 (33.3%) women), 776 (99.7%) completed the trial. At randomization, median respiratory rate was 33/min (IQR 28 to 39) versus 32 (IQR 27 to 38) and PaO2:FiO2 was 136 (IQR 96 to 187) versus 128 (IQR 92 to 164) in the intervention and control groups, respectively. Median SOFA score was 6 (IQR 4 to 8) in both groups. Mortality on day 28 was not significantly different between groups (35.6% versus 36.1%; difference -0.5% (95% CI -7.3% to +6.3%); hazard ratio 0.98 (95% CI 0.77 to 1.24); p = 0.94). Intubation rate was not significantly different between groups (38.7% versus 43.8%; difference -5.1% (95% CI -12.3% to +2.0%)). Compared with controls, patients randomized to high-flow oxygen therapy had a higher PaO2:FiO2 (150 versus 119; difference 19.5 (95% CI 4.4 to 34.6)) and lower respiratory rate after 6 hours (25/min versus 26/min; difference -1.8/min (95% CI -3.2 to -0.2)). No significant difference was observed in ICU length of stay (8 versus 6 days; difference 0.6 (95% CI -1.0 to +2.2)), ICU-acquired infections (10.0% versus 10.6%; difference -0.6% (95% CI -4.6 to +4.1)), hospital length of stay (24 versus 27 days; difference -2 days (95% CI -7.3 to +3.3)), or patient comfort and dyspnea scores. CONCLUSIONS AND RELEVANCE: Among critically ill immunocompromised patients with acute respiratory failure, high-flow oxygen therapy did not significantly decrease day-28 mortality compared with standard oxygen therapy. TRIAL REGISTRATION: ClinicalTrials.gov identifier NCT02739451.

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