Automated Ventilation in Comparison With Conventional Mechanical Ventilation

Background: INTELLiVENT-ASV is a closed-loop automated mechanical ventilation mode, adjusting parameters based on gas exchange and lung mechanics. This study compared conventional ventilation with automated ventilation to compare safety and efficacy. Methods: Prospective, multi-center, international, 1:1 randomized controlled study conducted between January 2021 and June 2022 at 5 hospitals in Europe and the USA enrolling adult mechanically ventilated subjects, which was stopped early because of the discontinuation of the G5/S1 ventilator platform. Subjects received automation or conventional mechanical ventilation through extubation. Primary end point was a composite “safety” and “efficacy” measure based upon gas exchange and mechanics. Secondary end points included outcomes, F IO 2 use, S pO 2 , and respiratory mechanics. Results: 62 subjects were enrolled and 60 analyzed with even distribution between groups, similar baseline characteristics, physiologic parameters, and ventilator settings. The percentage of breaths within the optimal “efficacy” windows (28% [19–37] vs 29% [8–39], P = .60) and within the optimal “safety” thresholds (16% [3–39] vs 13% [8–19], P = .66) was similar between groups. Subjects in the automated mode arm had significantly lower set F iO 2 and higher percentage of time spent in the “optimal” S pO 2 window (84 [70–97] vs 70 [51–87], P = .048), with qualitatively lower percentages spent in the “unacceptably low” and “acceptably higher” windows. Outcomes were similar between groups. Conclusions: Automation performed similarly to conventional nonautomated ventilation at multiple academic tertiary care centers, with similar respiratory mechanics and subject outcomes. Use of the automated mode resulted in lower F iO 2 , but a higher percentage of time spent in the “optimal” oxygenation window. Owing to the small number of subjects from the early stopping of the trial, these findings are exploratory and need validation in a larger number of subjects.