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CLINICAL TRIAL article

Front. Med.
Sec. Intensive Care Medicine and Anesthesiology
Volume 11 - 2024 | doi: 10.3389/fmed.2024.1426969
This article is part of the Research Topic Personalized Therapy in ARDS - Volume II View all 4 articles

Closed-loop Oxygen Usage During Invasive Mechanical Ventilation of Paediatric Patients (CLOUDIMPP): A Randomised Controlled Cross-over Study

Provisionally accepted
Gulhan Atakul Gulhan Atakul 1Gokhan Ceylan Gokhan Ceylan 1*Özlem Sarac Sandal Özlem Sarac Sandal 1Ekin Soydan Ekin Soydan 2Pinar Hepduman Pinar Hepduman 1Mustafa Colak Mustafa Colak 1Jan Zimmermann Jan Zimmermann 3Dominik Novotni Dominik Novotni 3Utku Karaarslan Utku Karaarslan 1Sevgi Topal Sevgi Topal 4Hasan Agin Hasan Agin 1
  • 1 Dr.Behçet Uz Children's Hospital, University of Health Sciences, Konak, Türkiye
  • 2 Other, Aydin, Türkiye
  • 3 Department of Medical Research, Hamilton-Medical, Chur, Switzerland
  • 4 Erzurum Regional Research and Training Hospital, Erzurum, Erzurum, Türkiye

The final, formatted version of the article will be published soon.

    Background The aim of this study is the evaluation of a closed-loop oxygen control system in paediatric patients undergoing invasive mechanical ventilation (IMV). Methods Cross-over, multicenter, randomised, single-blind clinical trial. Patients between the ages of one month and eighteen years who were undergoing IMV therapy for acute hypoxemic respiratory failure (AHRF) were assigned at random to either begin with a two-hour period of closed-loop oxygen control or manual oxygen titrations.By using closed-loop oxygen control, the patients' SpO2 levels were maintained within a predetermined target range by the automated adjustment of the FiO2. During the manual oxygen titration phase of the trial, healthcare professionals at the bedside made manual changes to the FiO2, while maintaining the same target range for SpO2. Following either period, the patient transitioned to the alternative therapy. The outcomes were the percentage of time spent in predefined SpO2 ranges ±2% (primary), FiO2, , total oxygen use, and the number of manual adjustments. Findings The median age of included 33 patients was 17 (13–55.5) months. In contrast to manual oxygen titrations, patients spent a greater proportion of time within a predefined optimal SpO2 range when the closed-loop oxygen controller was enabled (95·7% [IQR 92·1–100%] vs 65·6% [IQR 41·6–82·5%]), mean difference 33·4% [95%–CI 24·5–42%]; P<0.001). Median FiO2 was lower (32·1% [IQR 23·9–54·1%] vs 40·6% [IQR 31·1–62·8%]; P<0.001) similar to total oxygen use (19·8 L/h [IQR 4·6–64·8] vs 39·4 L/h [IQR 16·8–79]; P<0.001); however, median SpO2/FiO2 was higher (329·4 [IQR 180–411·1] vs 246·7 [IQR 151·1–320·5]; P<0.001) with closed–loop oxygen control. With closed–loop oxygen control, the median number of manual adjustments reduced (0·0 [IQR 0·0–0·0] vs 1 [IQR 0·0–2·2]; P<0.001). Conclusion Closed-loop oxygen control enhances oxygen therapy in pediatric patients undergoing IMV for AHRF, potentially leading to more efficient utilization of oxygen. This technology also decreases the necessity for manual adjustments, which could reduce the workloads of healthcare providers. Clinical Trial Registration This research has been submitted to ClinicalTrials.gov (NCT05714527)

    Keywords: hypoxemia, Oxygen therapy, Invasive mechanical ventilation, Automation, Closedloop, oxygen controller, Intensive Care, Paediatrics

    Received: 02 May 2024; Accepted: 13 Aug 2024.

    Copyright: © 2024 Atakul, Ceylan, Sarac Sandal, Soydan, Hepduman, Colak, Zimmermann, Novotni, Karaarslan, Topal and Agin. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.

    * Correspondence: Gokhan Ceylan, Dr.Behçet Uz Children's Hospital, University of Health Sciences, Konak, Türkiye

    Disclaimer: All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher.