Closed-loop synchronization versus conventional synchronization in spontaneously breathing pediatric patients (CHESTSIPP) - a randomized controlled cross-over study

Abstract

Background: Patient-ventilator asynchrony (PVA) is common during invasive mechanical ventilation in children and may increase respiratory workload and discomfort. The IntelliSync+ (IS+) algorithm provides closed-loop synchronization by continuously analyzing airway pressure and flow waveforms to optimize inspiratory and expiratory cycling in real time. This study evaluated the efficacy and safety of IS+ compared with conventional physician-tailored synchronization in spontaneously breathing pediatric patients. Methods: Multicenter, prospective, randomized controlled, single-blind crossover trial conducted in four pediatric intensive care units between March 2024 and May 2025. Patients aged 1 month to 18 years undergoing invasive mechanical ventilation were randomized to begin with either IS+ or conventional synchronization. Each mode was applied for 90 min (30-min run-in and 60-min measurement), separated by a 30-min washout period. The primary outcome was the Asynchrony Index (AI). Secondary outcomes included major and minor asynchrony indices, Comfort-B scores, end-tidal carbon dioxide (EtCO2), oxygen saturation (SpO(2)), and leak percentage. Findings: Twenty-five patients completed both study phases. Compared with conventional synchronization, IS+ significantly reduced the overall AI (median 5.1% [IQR 4.2-6.4] vs. 12.4% [IQR 9.9-15.6]; P < 0.001), as well as both major and minor asynchrony indices (P < 0.001 for both). The frequencies of double triggering, auto-triggering, trigger delay, and early cycling decreased significantly, while ineffective efforts were unchanged and late cycling slightly increased. Comfort-B scores improved modestly (P = 0.02) and EtCO2 decreased (P < 0.001), whereas SpO(2) and leak remained stable. Conclusion: Closed-loop synchronization with IS+ significantly improved patient-ventilator interaction without compromising comfort, oxygenation, or safety. These results support closed-loop synchronization as a feasible and physiologically sound strategy for improving ventilatory support quality in pediatric invasive mechanical ventilation.