Automated closed–loop FiO(2) titration increases the percentage of time spent in optimal zones of oxygen saturation in pediatric patients–A randomized crossover clinical trial

INTRODUCTION: We aimed to compare automated ventilation with closed–loop control of the fraction of inspired oxygen (FiO(2)) to automated ventilation with manual titrations of the FiO(2) with respect to time spent in predefined pulse oximetry (SpO(2)) zones in pediatric critically ill patients. METHODS: This was a randomized crossover clinical trial comparing Adaptive Support Ventilation (ASV) 1.1 with use of a closed–loop FiO(2) system vs. ASV 1.1 with manual FiO(2) titrations. The primary endpoint was the percentage of time spent in optimal SpO(2) zones. Secondary endpoints included the percentage of time spent in acceptable, suboptimal and unacceptable SpO(2) zones, and the total number of FiO(2) changes per patient. RESULTS: We included 30 children with a median age of 21 (11–48) months; 12 (40%) children had pediatric ARDS. The percentage of time spent in optimal SpO(2) zones increased with use of the closed–loop FiO(2) controller vs. manual oxygen control [96.1 (93.7–98.6) vs. 78.4 (51.3–94.8); P < 0.001]. The percentage of time spent in acceptable, suboptimal and unacceptable zones decreased. Findings were similar with the use of closed-loop FiO(2) controller compared to manual titration in patients with ARDS [95.9 (81.6–98.8) vs. 78 (49.5–94.8) %; P = 0.027]. The total number of closed-loop FiO(2) changes per patient was 52 (11.8–67), vs. the number of manual changes 1 (0–2), (P < 0.001). CONCLUSION: In this randomized crossover trial in pediatric critically ill patients under invasive ventilation with ASV, use of a closed–loop control of FiO(2) titration increased the percentage of time spent within in optimal SpO(2) zones, and increased the total number of FiO(2) changes per patient. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, identifier: NCT04568642.