Ventilation & weaning · Non-invasive ventilation in hypoxaemic failure
Noninvasive ventilation in severe hypoxemic respiratory failure
| Design | Randomised clinical trial in three hospitals |
|---|---|
| Treatment | Non-invasive ventilation |
| Control | High-concentration oxygen therapy |
| Population | 105 patients with severe acute hypoxaemic respiratory failure, excluding hypercapnia |
| Inclusion criteria | PaO2 60 mmHg or less, or saturation 90% or less, persisting on Venturi oxygen at 50%, without hypercapnia. |
| Follow-up | 90 days |
| Primary endpoint | Intubation rate |
| Result | Intubation occurred in 13 of 51 (25%) with non-invasive ventilation versus 28 of 54 (52%) with oxygen (p=0.010). Septic shock occurred in 12% versus 31% (p=0.028) and ICU mortality was 18% versus 39% (p=0.028), with better cumulative 90-day survival (p=0.025). On multivariate analysis non-invasive ventilation was independently associated with lower intubation risk (odds ratio 0.20, p=0.003) and 90-day mortality (odds ratio 0.39, p=0.017). |
| Secondary endpoints | Septic shock, ICU mortality, 90-day survival, gas exchange |
The use of noninvasive ventilation prevented intubation, reduced the incidence of septic shock, and improved survival in these patients compared with high-concentration oxygen therapy.
The trial authors, in the published abstract
A striking early positive result that later trials struggled to reproduce — FLORALI found non-invasive ventilation the worst of its three arms in a similar population. Small, single-country and pre-dating high-flow oxygen entirely, it is best read as the origin of a question rather than its answer.
Ferrer M, Esquinas A, Leon M, et al. Noninvasive ventilation in severe hypoxemic respiratory failure: a randomized clinical trial. Am J Respir Crit Care Med 2003 Dec 15;168(12):1438-44.