Respiratory failure & ventilation
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
Primary resultResult — go to the resultAbsolute difference −9.0% 95% one-sided CI −15.4% to −2.5%- Terminated by the data and safety monitoring board and trial steering committee after interim analysis of the first 300 patients
Authors' conclusion
Patients with COPD and persistent hypercapnia in the high-intensity NPPV group (vs patients in the low-intensity NPPV group) were significantly less likely to meet criteria for the need for endotracheal intubation; however, patients in the low-intensity NPPV group were allowed to crossover to high-intensity NPPV, and the between-group rate of endotracheal intubation was not significantly different.
Study context
- Population
- Patients with acute exacerbation of chronic obstructive pulmonary disease (COPD) and PaCO2 >45 mm Hg after 6 hours of low-intensity noninvasive positive pressure ventilation (NPPV), 30 general respiratory non-ICU wards of Chinese hospitalsall analysed
- Participants
- 300 patients
- Comparison
- High-intensity vs low-intensity NPPV
- High-intensity NPPVn = 147
- Low-intensity NPPVn = 153reference
- Primary endpoint
- Need for endotracheal intubation (meeting prespecified criteria)
- Follow-up
- During hospitalization
Methodological detailsmulticentre, 1:1 randomisation, terminated after interim analysis
- Multicentre
- 1:1 randomisation
- Terminated after interim analysis
Primary result
As reported in the abstract
Absolute difference
−9.0%
95% one-sided CI −15.4% to −2.5%
P = 0.004
Events by treatment group
High-intensity NPPV vs Low-intensity NPPV
absolute difference −9.0% (95% one-sided CI −15.4% to −2.5%); P = 0.004
Secondary outcomes
| Outcome | High-intensity NPPV | Low-intensity NPPV | Absolute difference (95% CI) | P value | |
|---|---|---|---|---|---|
| Endotracheal intubation | 3.4% | 3.9% | −0.5% (−4.8% to 3.7%) | P = 0.81 | |
| −6−4−2024Difference (linear scale) |
Safety
Abdominal distension
Original publication
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. Published 26 November 2024. doi:10.
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