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Automated control of inspired oxygen fraction in mechanically ventilated patients: A study protocol for a

Christine Eimer¹, Helene Selpien², Tatiana Bastian²

¹Department for Anesthesiology and Intensive Care Medicine, University Medical Center Schleswig-Holstein, Kiel, Schleswig-Holstein, Germany christine.eimer@uksh.de.

|May 30, 2025

Abstract

Background:

A novel automated system for the control of the inspired fraction of oxygen, named LeoClac, has been implemented on a mechanical ventilator. The system uses a separate sensor for the measurement of peripheral oxygen saturation which is connected directly to the ventilator. We hypothesise that LeoClac will be superior to manual control in keeping critically ill and mechanically ventilated patients in a SpO₂-target range (93-96%).

Methods:

This is a randomised controlled, single-centre superiority study with two parallel groups including 40 patients. Mechanically ventilated patients treated on the intensive care unit (ICU) will be screened for eligibility and included in the study after written informed consent. Patients in the intervention group will be treated with LeoClac. In the control group, FiO₂ will be controlled manually by the intensive care team. The primary endpoint of the study is the proportion of time in the target zone for peripheral oxygen saturation within the first 24 hours following randomisation. Secondary endpoints include the analysis of hyperoxia and hypoxia, number of changes in FiO₂, number and reasons for self-aborts and manual overrides of the automated system, proportion of time in target zone for peripheral oxygen saturation in the subgroups of patients with hypoxemic respiratory failure and acute hypercapnic respiratory failure. Furthermore, ventilator-free days and ICU mortality at day 28 will be analysed.

Analysis:

The precise control of FiO₂ with the aim of avoiding both hyperoxia and hypoxia is a fundamental challenge in the highly technical field of mechanical ventilation. Incorporation of patient heterogeneity, the benefits of reduced manual intervention and the potential to optimise treatment outcomes underscore the importance of this research. By addressing the complexities of precise oxygen control in adults, this study contributes to the advancement of critical care practices and may improve patient outcomes.

Ethics:

The study protocol was approved by the ethics committee of the Christian-Albrechts-University Kiel, Germany, on 17 May 2023.

Trial Registration Number:

DRKS00032113.

Keywords:

ANAESTHETICS INTENSIVE & CRITICAL CARE Lung Diseases Oxygen Saturation Ventilators, Mechanical

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