Effect of High-Flow Nasal Oxygen vs Standard Oxygen on 28-Day Mortality in Immunocompromised Patients With Acute Respiratory Failure: The HIGH Randomized Clinical Trial

• Published in: JAMA : the journal of the American Medical Association Vol. 320; no. 20; pp. 2099 - 2107
• Main Authors: Azoulay, Elie, Lemiale, Virginie, Mokart, Djamel, Nseir, Saad, Argaud, Laurent, Pène, Frédéric, Kontar, Loay, Bruneel, Fabrice, Klouche, Kada, Barbier, François, Reignier, Jean, Berrahil-Meksen, Lilia, Louis, Guillaume, Constantin, Jean-Michel, Mayaux, Julien, Wallet, Florent, Kouatchet, Achille, Peigne, Vincent, Théodose, Igor, Perez, Pierre, Girault, Christophe, Jaber, Samir, Oziel, Johanna, Nyunga, Martine, Terzi, Nicolas, Bouadma, Lila, Lebert, Christine, Lautrette, Alexandre, Bigé, Naike, Raphalen, Jean-Herlé, Papazian, Laurent, Darmon, Michael, Chevret, Sylvie, Demoule, Alexandre
• Format: Journal Article
• Language: English
• Published: United States American Medical Association 27.11.2018
• Subjects: Adult; Aged; Caring for the Critically Ill Patient; Clinical trials; Critical Illness - mortality; Critical Illness - therapy; Design standards; Dyspnea; Female; High-Frequency Ventilation; Hospitals; Humans; Immunocompromised Host; Immunocompromised hosts; Impact analysis; Infections; Intensive care units; Intubation; Male; Mechanical ventilation; Mercury; Middle Aged; Mortality; Noninvasive Ventilation; Nose; Online First; Original Investigation; Oxygen; Oxygen Inhalation Therapy - instrumentation; Oxygen Inhalation Therapy - methods; Patients; Respiration; Respiratory diseases; Respiratory failure; Respiratory Insufficiency - mortality; Respiratory Insufficiency - therapy; Respiratory rate; Survival Analysis; Tachypnea; Therapy; Ventilation
• ISSN: 0098-7484; 1538-3598
• DOI: 10.1001/jama.2018.14282

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 mm Hg 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, 54-71] years; 259 [33.3%] women), 776 (99.7%) completed the trial. At randomization, median respiratory rate was 33/min (IQR, 28-39) vs 32 (IQR, 27-38) and Pao2:Fio2 was 136 (IQR, 96-187) vs 128 (IQR, 92-164) in the intervention and control groups, respectively. Median SOFA score was 6 (IQR, 4-8) in both groups. Mortality on day 28 was not significantly different between groups (35.6% vs 36.1%; difference, −0.5% [95% CI, −7.3% to +6.3%]; hazard ratio, 0.98 [95% CI, 0.77 to 1.24]; P = .94). Intubation rate was not significantly different between groups (38.7% vs 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 vs 119; difference, 19.5 [95% CI, 4.4 to 34.6]) and lower respiratory rate after 6 hours (25/min vs 26/min; difference, −1.8/min [95% CI, −3.2 to −0.2]). No significant difference was observed in ICU length of stay (8 vs 6 days; difference, 0.6 [95% CI, −1.0 to +2.2]), ICU-acquired infections (10.0% vs 10.6%; difference, −0.6% [95% CI, −4.6 to +4.1]), hospital length of stay (24 vs 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.