In a large, randomized trial conducted in 42 ICUs in France, high-flow oxygen did not reduce 28-day all-cause mortality in adult patients with acute hypoxemic respiratory failure when compared to standard oxygen support.

Additional Information

The SOHO Trial

• An investigator-initiated, open-label RCT
• Conducted in 42 ICUs in France
• Included adult patients who were admitted to the ICU with acute hypoxemic respiratory failure
• Excluded patients with a COPD exacerbation, chronic lung disease, acute cardiogenic pulmonary edema, hemodynamically unstable, or those who needed emergent intubation.
• Patients were randomized to either a High-Flow oxygen group or a Standard oxygen group.
• The primary outcome was 28-day all-cause mortality.
• Secondary outcomes included intubation by day 28, ventilator free days, ICU mortality, in-hospital mortality, 90-day mortality, and ICU/hospital LOS.
• A total of 1,110 patients were included in the intention-to-treat analysis.  The High-Flow group had 556 patients and the Standard group had 554 patients.
• The primary outcome occurred in 14.6% of patients in the High-Flow group and in 14.6% of patients in the Standard group.
• With respect to secondary outcomes, the incidence of intubation at day 28 was lower in the High-Flow group.  In addition, the high-flow appeared to reduce dyspnea scores, and improve respiratory rates and CO2 values.
• Limitations of the SOHO trial included a lower than expected mortality (underpowered) and a high percentage of patients with viral pneumonia.