PARIS-2
Trial question
What is the effect of early high-flow nasal oxygen therapy in hospitalized children with acute hypoxemic respiratory failure?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
48.0% female
52.0% male
N = 1517
1517 patients (732 female, 785 male)
Inclusion criteria: pediatric patients aged 1-4 years requiring hospital admission for acute hypoxemic respiratory failure
Key exclusion criteria: craniofacial abnormalities; upper airway obstruction; cyanotic heart disease; and requirement of immediate higher-level care in the ICU or noninvasive or invasive mechanical ventilation
Interventions
N=753 high-flow oxygen therapy (high-flow therapy with nasal cannula at weight-specific flows)
N=764 standard oxygen therapy (oxygen using subnasal cannula with flows up to 2 L/min or using a Hudson face mask)
Primary outcome
Median length of hospital stay
1.77
1.5
1.8 days
1.3 days
0.9 days
0.4 days
0.0 days
High-flow oxygen
therapy
Standard oxygen
therapy
Significant
decrease ▼
Significant decrease in median length of hospital stay (1.77 days vs. 1.5 days; HR 0.83, 95% CI 0.75 to 0.92)
Secondary outcomes
Borderline significant increase in median length of oxygen therapy (1.07 days vs. 0.75 days; HR 1.28, 95% CI 1.16 to 1.42)
Borderline significant increase in escalation of care to ICU (12.5% vs. 6.9%; OR 1.93, 95% CI 1.35 to 2.75)
Borderline significant increase in change in oxygen therapy in general ward or emergency department (42.9% vs. 18.5%; OR 3.42, 95% CI 2.7 to 4.34)
Safety outcomes
No significant difference in adverse events including death.
Conclusion
In pediatric patients aged 1-4 years requiring hospital admission for acute hypoxemic respiratory failure, high-flow oxygen therapy was inferior to standard oxygen therapy with respect to median length of hospital stay.
Reference
Donna Franklin, Franz E Babl, Shane George et al. Effect of Early High-Flow Nasal Oxygen vs Standard Oxygen Therapy on Length of Hospital Stay in Hospitalized Children With Acute Hypoxemic Respiratory Failure The PARIS-2 Randomized Clinical Trial. JAMA. 2023 Jan 17;329(3):224-234.
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