Purpose: Continuous positive airway pressure (CPAP) is a useful treatment for patients with acute cardiogenic pulmonary oedema (CPE). However, its usefulness in the out-of-hospital setting has been poorly investigated and only by small and single-centre studies. We designed a multicentre randomised study to assess the benefit of CPAP initiated out of hospital.
Methods: A total of 207 patients with CPE were randomly allocated by emergency mobile medical units to receive either standard treatment alone or standard treatment plus CPAP. CPAP was maintained after admission to the intensive care unit (ICU). Inclusion criteria were orthopnoea, respiratory rate greater than 25 breaths/min, pulse oximetry less than 90% in room air and diffuse crackles. The primary end point was assessed during the first 48 h and combined: death, presence of intubation criteria, persistence of either all inclusion criteria or circulatory failure at the second hour or their reappearance before 48 h. Absence of all criteria defined successful treatment.
Results: CPAP was used for 60 min [40, 65] (median [Q1, Q3]) in the pre-hospital setting and 120 min [60, 242] in ICU and was well tolerated in all patients. Treatment was successful in 79% of patients in the CPAP group and 63% in the control group (p = 0.01), especially for persistence of inclusion criteria after 2 h (12 vs. 26%) and for intubation criteria (4 vs. 14%). CPAP was beneficial irrespective of the initial PaCO(2) or left ventricular ejection fraction.
Conclusion: Immediate use of CPAP in out-of-hospital treatment of CPE and until CPE resolves after admission significantly improves early outcome compared with medical treatment alone.
Trial registration: ClinicalTrials.gov NCT00554580.