HiFlo-COVID

Trial question
Is high-flow oxygen therapy through a nasal cannula superior to conventional oxygen therapy in patients with severe COVID-19?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
33.0% female
67.0% male
N = 199
199 patients (65 female, 134 male).
Inclusion criteria: adult patients with respiratory distress and a ratio of partial pressure of arterial oxygen to FiO2 < 200 due to COVID-19.
Key exclusion criteria: indication for immediate orotracheal intubation, pregnancy, chronic liver disease, active bacterial or fungal infection, history of COPD.
Interventions
N=99 high-flow oxygen therapy (breathing support with high-flow oxygen therapy through a nasal cannula).
N=100 conventional oxygen therapy (oxygen therapy by conventional nasal cannula/prongs, venturi mask, or mask with reservoir).
Primary outcome
Rate of intubation within 28 days
34.3%
51%
51.0 %
38.3 %
25.5 %
12.8 %
0.0 %
High-flow oxygen therapy
Conventional oxygen therapy
Significant decrease ▼
NNT = 5
Significant decrease in the rate of intubation within 28 days (34.3% vs. 51%; HR 0.62, 95% CI 0.39 to 0.96).
Secondary outcomes
Significant increase in the rate of clinical recovery within 28 days (77.8% vs. 71%; HR 1.39, 95% CI 1 to 1.92).
Significant increase in ventilator-free days at day 28 (28 days vs. 24 days; OR 2.08, 95% CI 1.18 to 3.64).
No significant difference in death at day 28 (8.1% vs. 16%; HR 0.49, 95% CI 0.21 to 1.16).
Safety outcomes
No significant differences in suspected bacterial pneumonia, bacteremia.
Conclusion
In adult patients with respiratory distress and a ratio of partial pressure of arterial oxygen to FiO2 < 200 due to COVID-19, high-flow oxygen therapy was superior to conventional oxygen therapy with respect to the rate of intubation within 28 days.
Reference
Gustavo A Ospina-Tascón, Luis Eduardo Calderón-Tapia, Alberto F García et al. Effect of High-Flow Oxygen Therapy vs Conventional Oxygen Therapy on Invasive Mechanical Ventilation and Clinical Recovery in Patients With Severe COVID-19: A Randomized Clinical Trial. JAMA. 2021 Dec 7;326(21):2161-2171.
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