Closed-loop Versus Conventional Synchronization in Spontaneously Breathing Adult Patients- a Randomized Controlled Study.

BACKGROUND:The IntelliSync+ [IS+] algorithm provides closed-loop synchronization by continuously analyzing airway pressure and flow waveforms in real time to optimize inspiratory and expiratory cycling. This study evaluated the efficacy of IS+ compared with conventional physician-tailored synchronization during noninvasive ventilation [NIV] in spontaneously breathing adult patients with ARF. METHODS:This multicenter, prospective, randomized controlled, single-blind crossover trial was conducted between March 2024 and May 2025 in two tertiary hospitals. Adult patients receiving NIV for ARF were randomized to start with either conventional synchronization or IS+. Each mode was applied for 30 min, separated by a 15-min washout period. The primary outcome was the Asynchrony Index [AI], defined as the number of asynchronous events per 100 breaths. RESULTS:Compared with conventional synchronization, IS+ significantly reduced the total AI [11.8 (7.9-22.4) vs. 25.5 (12.1-35.3) events/100 breaths, p < 0.001], as well as both major and minor asynchrony indices [8.3 (4.5-16.4) vs. 17.6 (7.5-25.6), p < 0.001; 3.4 (1.5-5.4) vs. 7.6 (3.4-13.6), p < 0.001, respectively]. Dyspnea scores were significantly reduced during IS+ [3 ± 1 vs. 5 ± 1, p = 0.0001], indicating improved comfort. CONCLUSIONS:Closed-loop synchronization using IS+ significantly improved patient-ventilator interaction and comfort during NIV in adults with acute respiratory failure with no adverse events observed during the study period. This study demonstrates that synchrony during NIV can be enhanced using a closed-loop algorithm alone, solely through real-time waveform analysis, without the need for additional invasive monitoring. Clinical Trials ID: NCT06357780.