Closed-loop oxygen control improves oxygenation in pediatric patients under high-flow nasal oxygen-A randomized crossover study

Ozlem Sandal; Gokhan Ceylan; Sevgi Topal; Pinar Hepduman; Mustafa Colak; Dominik Novotni; Ekin Soydan; Utku Karaarslan; Gulhan Atakul; Marcus J Schultz; Hasan Ağın

doi:10.3389/fmed.2022.1046902

Closed-loop oxygen control improves oxygenation in pediatric patients under high-flow nasal oxygen-A randomized crossover study

Front Med (Lausanne). 2022 Nov 16:9:1046902. doi: 10.3389/fmed.2022.1046902. eCollection 2022.

Authors

Ozlem Sandal¹, Gokhan Ceylan^{1

2}, Sevgi Topal³, Pinar Hepduman¹, Mustafa Colak⁴, Dominik Novotni², Ekin Soydan¹, Utku Karaarslan¹, Gulhan Atakul¹, Marcus J Schultz^{2

5

6

7}, Hasan Ağın¹

Affiliations

¹ Department of Pediatric Intensive Care Unit, Dr. Behcet Uz Children's Disease and Surgery Training and Research Hospital, Health Sciences University, İzmir, Turkey.
² Department of Medical Research, Hamilton Medical AG, Bonaduz, Switzerland.
³ Department of Pediatric Intensive Care Unit, Erzurum Territorial Training and Research Hospital, Health Sciences University, Erzurum, Turkey.
⁴ Department of Pediatric Intensive Care Unit, Cam Sakura Training and Research Hospital, Health Sciences University, Istanbul, Turkey.
⁵ Department of Intensive Care, Amsterdam UMC, Academic Medical Center, Amsterdam, Netherlands.
⁶ Tropical Medicine Research Unit, Mahidol University, Bangkok, Thailand.
⁷ Nuffield Department of Medicine, University of Oxford, Oxford, United Kingdom.

Abstract

Background: We assessed the effect of a closed-loop oxygen control system in pediatric patients receiving high-flow nasal oxygen therapy (HFNO).

Methods: A multicentre, single-blinded, randomized, and cross-over study. Patients aged between 1 month and 18 years of age receiving HFNO for acute hypoxemic respiratory failure (AHRF) were randomly assigned to start with a 2-h period of closed-loop oxygen control or a 2-h period of manual oxygen titrations, after which the patient switched to the alternative therapy. The endpoints were the percentage of time spent in predefined SpO₂ ranges (primary), FiO₂, SpO₂/FiO₂, and the number of manual adjustments.

Findings: We included 23 patients, aged a median of 18 (3-26) months. Patients spent more time in a predefined optimal SpO₂ range when the closed-loop oxygen controller was activated compared to manual oxygen titrations [91⋅3% (IQR 78⋅4-95⋅1%) vs. 63⋅0% (IQR 44⋅4-70⋅7%)], mean difference [28⋅2% (95%-CI 20⋅6-37⋅8%); P < 0.001]. Median FiO₂ was lower [33⋅3% (IQR 26⋅6-44⋅6%) vs. 42⋅6% (IQR 33⋅6-49⋅9%); P = 0.07], but median SpO₂/FiO₂ was higher [289 (IQR 207-348) vs. 194 (IQR 98-317); P = 0.023] with closed-loop oxygen control. The median number of manual adjustments was lower with closed-loop oxygen control [0⋅0 (IQR 0⋅0-0⋅0) vs. 0⋅5 (IQR 0⋅0-1⋅0); P < 0.001].

Conclusion: Closed-loop oxygen control improves oxygenation therapy in pediatric patients receiving HFNO for AHRF and potentially leads to more efficient oxygen use. It reduces the number of manual adjustments, which may translate into decreased workloads of healthcare providers.

Clinical trial registration: [www.ClinicalTrials.gov], identifier [NCT05032365].

Keywords: automation; closed-loop; high flow (NHF); hypoxemia; intensive care; oxygen controller; oxygen therapy; pediatric [MeSH].

Associated data

ClinicalTrials.gov/NCT05032365