OBJECTIVE: Our objective was to evaluate the efficacy of noninvasive continuous positive airway pressure (CPAP) delivered by helmet in improving oxygenation in comparison with oxygen therapy in community-acquired pneumonia (CAP). METHODS: This was a multicenter, randomized, controlled trial enrolling patients with CAP admitted to an ED with moderate hypoxemic acute respiratory failure (ARF) (PaO2/FiO2 ratio >= 210 and <= 285). Patients were randomized to helmet CPAP or standard oxygen therapy (control group). The primary end point was the time to reach a PaO2/FiO2 ratio > 315. After reaching this value, patients randomized to CPAP were switched to oxygen, and the proportion of subjects who could maintain a PaO2/FiO2 ratio > 315 at 1 h was recorded. RESULTS: Forty-seven patients were recruited: 20 randomized to CPAP and 27 to controls. Patients randomized to CPAP reached the end point in a median of 1.5 h, whereas controls reached the end point in 48 h (p < 0.001). The proportion of patients who reached the primary end point was 95% (19/20) among the CPAP group and 30% (8/27) among controls (p < 0.001). One hour after reaching the primary end point, 2/14 patients in the CPAP group maintained a PaO2/FiO2 value > 315. CONCLUSIONS: CPAP delivered by helmet rapidly improves oxygenation in patients with CAP suffering from a moderate hypoxemic ARF. This trial represents a proof-of-concept evaluation of the potential usefulness of CPAP in patients with CAP. TRIAL REGISTRATION: ClinicalTrials.gov; identifier NCT00603564.

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