Simple lightweight disposable continuous positive airways pressure mask to effectively treat acute pulmonary oedema: Randomized controlled trial

Abstract

To compare the novel Boussignac valve continuous positive airways pressure (CPAP) delivery mask and a standard closed-circuit Drager CF800 CPAP system in the management of acute pulmonary oedema (APO) patients. This was a randomized controlled trial whereby patients presenting to the ED with APO and who met the study criteria received either CPAP via the Boussignac valve system or from a standard Drager CF800. Baseline physiological and arterial gas data were recorded and repeated at 30 and 60 min after CPAP commenced. The primary outcome was mean change in pCO2 at 60 min between the two systems. There were 39 evaluable patients (19 Boussignac, 20 Drager). The mean change in pCO2 at 60 min compared to baseline was similar in the two groups (Boussignac 0.9 kPa vs. Drager 1.2 kPa, mean difference -0.3; 95% CI -1.0-0.5, P=0.45). In addition, there were no significant differences at 60 min in regards to respiratory rate decrease, Boussignac 17.3/min versus Drager 19.6/min (mean difference 1.3; 95% CI -3.3-5.8, P=0.58) or peripheral SaO2 increase, Boussignac 10.7% versus Drager 14.6% (mean difference -3.9; 95% CI -9.9-2.1, P=0.19). There was no significant difference in disposition from the ED or the complication rate. The Boussignac valve system may be an effective lightweight disposable method of delivering CPAP to patients with APO. It appears to perform as effectively as much larger, more expensive and less transportable equipment.