HAPPEN
Trial question
What is the role of high-intensity noninvasive positive pressure ventilation in patients with acute exacerbation of COPD and persistent hypercapnia?
Study design
Multi-center
Single blinded
RCT
Population
Characteristics of study participants
32.0% female
68.0% male
N = 300
300 patients (97 female, 203 male).
Inclusion criteria: patients with acute exacerbation of COPD and persistent hypercapnia.
Key exclusion criteria: age < 18 years; excessive respiratory secretions or an upper airway obstruction; recent oral, facial, or cranial trauma or surgery; recent gastric or esophageal surgery; restrictive ventilatory dysfunction; active bleeding in the upper gastrointestinal tract; recent cardiac or respiratory arrest.
Interventions
N=147 high-intensity NPPV (inspiratory positive airway pressure adjusted to obtain tidal volume of 10-15 mL/kg of predicted body weight).
N=153 low-intensity NPPV (inspiratory positive airway pressure adjusted to obtain tidal volume of 6-10 mL/kg of predicted body weight).
Primary outcome
Need for endotracheal intubation during hospitalization
4.8%
13.7%
13.7 %
10.3 %
6.8 %
3.4 %
0.0 %
High-intensity
NPPV
Low-intensity
NPPV
Significant
decrease ▼
NNT = 11
Significant decrease in need for endotracheal intubation during hospitalization (4.8% vs. 13.7%; RR 0.35, 95% CI 0.14 to 0.76).
Secondary outcomes
No significant difference in endotracheal intubation (3.4% vs. 3.9%; RR 0.87, 95% CI 0.25 to 2.72).
Significant decrease in endotracheal intubation (3.4% vs. 11.1%; RR 0.31, 95% CI 0.1 to 0.76).
No significant difference in death at day 90 (4.1% vs. 4%; RR 1.04, 95% CI 0.33 to 3.11).
Safety outcomes
No significant difference in serious adverse events.
Significant difference in abdominal distension (37.4% vs. 25.5%).
Conclusion
In patients with acute exacerbation of COPD and persistent hypercapnia, high-intensity NPPV was superior to low-intensity NPPV with respect to need for endotracheal intubation during hospitalization.
Reference
Zujin Luo, Yichong Li, Wenjun Li et al. Effect of High-Intensity vs Low-Intensity Noninvasive Positive Pressure Ventilation on the Need for Endotracheal Intubation in Patients With an Acute Exacerbation of Chronic Obstructive Pulmonary Disease: The HAPPEN Randomized Clinical Trial. JAMA. 2024 Sep 16:e2415815.
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