Confalonieri M, et al. Acute respiratory failure in patients with severe community-acquired pneumonia. A prospective randomized evaluation of noninvasive ventilation. Am J Respir Crit Care Med. 1999 Nov;160(5 Pt 1):1585-91
To compare standard treatment plus NPPV delivered through a face mask to standard treatment alone in patients with severe CAP and ARF.
Prospective, randomized study of consecutive adult patients (N=56) who had severe CAP (American Thoracic Society criteria) in presence of ARF (refractory hypoxemia and/or hypercapnia with acidosis)
Both arms received standard medical management: antibiotic administration following ATS guidelines (later adjusted to the results of bacterial culture and antibiogram); Oxygen to achieve a level of arterial oxygen saturation above 90%.
Bronchodilators, chest physiotherapy, and corticosteroids were used at the discretion of the attending physician.
Intervention arm also received NPPV administed by full-face mask
Outcomes measured: intubation, duration of ICU stay and of hospital stay, hospital mortality and 2 month mortality.
Patients in 2 groups were similar in age, blood gases, RR, and APACHE II score
Significantly more patients in the standard treatment arm met preselected criteria for intubation at start of study.
Complete follow-up and intention-to-treat anaylsis
Table 3 compares outcomes of the 2 arms. Statistically significant difference in duration of ICU stay and intubation rate. No statiscally significant difference in mortality (in hospital or at 2 months).
Table 4 compares outcomes for patients with COPD (n=23) separately from patients without COPD. There was a difference in 2 month mortality, but the numbers were very small (at 2 mos. mortality rates were: 1/9 for NPPV group and 5/8 for standard treatment group.)