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

Ekin Soydan, Gokhan Ceylan, Sevgi Topal, Pinar Hepduman, Gulhan Atakul, Mustafa Colak, Ozlem Sandal, Ferhat Sari, Utku Karaarslan, Dominik Novotni, Marcus J Schultz, Hasan Agin, Ekin Soydan, Gokhan Ceylan, Sevgi Topal, Pinar Hepduman, Gulhan Atakul, Mustafa Colak, Ozlem Sandal, Ferhat Sari, Utku Karaarslan, Dominik Novotni, Marcus J Schultz, Hasan Agin

Abstract

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.

Keywords: ASV; Adaptive support ventilation; FiO2 controller; automated ventilation; closed loop ventilation; intensive care; mechanical ventilation; pediatric intensive care.

Conflict of interest statement

Authors GC, DN, and MS report conflicts of interest, they are both employed by Hamilton Medical AG in the Department of Medical Research. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest. The handling editor DB declared a past co-authorship with the author MS.

Copyright © 2022 Soydan, Ceylan, Topal, Hepduman, Atakul, Colak, Sandal, Sari, Karaarslan, Novotni, Schultz and Agin.

Figures

Figure 1
Figure 1
Study Protocol. Run-in: Patient was ventilated with the same mode as Phase 1, excluded from data analysis; Wash-out: Patient was ventilated with the same mode as Phase 2, excluded from data analysis.
Figure 2
Figure 2
Consort 2010 flow diagram.
Figure 3
Figure 3
Comparison of duration in optimal target (DOT) SpO2 between study phases. {The median percentage of time spent in the optimal zone was 96.4% [93.6–98.7 (IQR)] when the FiO2 controller was activated and the median percentage of time spent in the optimal zone was 78.4% [51.4–98 (IQR)] when FiO2 was controlled manually (p < 0.001)}.
Figure 4
Figure 4
Percentage of time spent in unacceptably high/low, acceptably high/low, optimal SpO2 zones. For illustrative purposes, width of each bar represents the mean percentage of time spent.

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