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

doi:10.3389/fmed.2022.969218

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

Front Med (Lausanne). 2022 Aug 25:9:969218. doi: 10.3389/fmed.2022.969218. eCollection 2022.

Authors

Ekin Soydan¹, Gokhan Ceylan^{1

2}, Sevgi Topal¹, Pinar Hepduman¹, Gulhan Atakul¹, Mustafa Colak¹, Ozlem Sandal¹, Ferhat Sari¹, Utku Karaarslan¹, Dominik Novotni², Marcus J Schultz^{2

3}, Hasan Agin¹

Affiliations

¹ Department of Pediatric Intensive Care Unit, Dr. Behcet Uz Children's Disease and Surgery Training and Research Hospital, Health Sciences University, Izmir, Turkey.
² Department of Medical Research, Hamilton Medical AG, Bonaduz, Switzerland.
³ Department of Intensive Care, Amsterdam UMC, Location "Academic Medical Center", Amsterdam, Netherlands.

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.

Publication types

Case Reports

Associated data

ClinicalTrials.gov/NCT04568642