Table_1_Automated closed–loop FiO2 titration increases the percentage of time spent in optimal zones of oxygen saturation in pediatric patients–A randomized crossover clinical trial.DOCX

Introduction

We aimed to compare automated ventilation with closed–loop control of the fraction of inspired oxygen (FiO₂) to automated ventilation with manual titrations of the FiO₂ with respect to time spent in predefined pulse oximetry (SpO₂) 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 FiO₂ system vs. ASV 1.1 with manual FiO₂ titrations. The primary endpoint was the percentage of time spent in optimal SpO₂ zones. Secondary endpoints included the percentage of time spent in acceptable, suboptimal and unacceptable SpO₂ zones, and the total number of FiO₂ 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 SpO₂ zones increased with use of the closed–loop FiO₂ 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 FiO₂ 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 FiO₂ 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 FiO₂ titration increased the percentage of time spent within in optimal SpO₂ zones, and increased the total number of FiO₂ changes per patient.

Clinical trial registration

ClinicalTrials.gov, identifier: NCT04568642.