INTRODUCTION: This study aimed to compare the effectiveness of two methods for non-invasive mechanical ventilation in patients with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)- using a helmet interface with a flow meter and positive end-expiratory pressure valve versus a traditional mechanical ventilator. MATERIAL AND METHODS: We conducted a single-center randomized clinical trial involving 100 adult SARS-CoV-2 patients in a specialized private hospital. Participants were randomly assigned to two groups: one using the helmet interface with a flow meter and positive end-expiratory pressure valve and the other employing conventional mechanical ventilation. Our study included participant selection, blood gas analysis, assessment of respiratory rate, peripheral oxygen saturation, modified Borg scale scores, and a visual analog scale. RESULTS: The study showed no significant difference in intubation rates between the mechanical ventilation (54.3%) and helmet interface with flow meter and positive end-expiratory pressure valve (46.8%) groups (p = 0.37). Additionally, the helmet group had a shorter average duration of use (3.4 +/- 1.6 days) compared to the mechanical ventilation group (4.0 +/- 1.9 days). The helmet group also had a shorter average hospitalization duration (15.9 +/- 7.9 days) compared to the mechanical ventilation group (17.1 +/- 9.5 days). CONCLUSIONS: This single-center randomized clinical trial found no statistically significant differences between the two methods of non-invasive ventilation. Implications for clinical practice: using the helmet interface with the flow meter and positive end-expiratory pressure valve can simplify device installation, potentially reducing the need for intubation, making it a valuable tool for nurses and physiotherapists in daily clinical practice.

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