Eimer Christine, Selpien Helene, Bastian Tatiana, Hartmann Lara, Sablewski Armin, Lindner Matthias, Becher Tobias, Schädler Dirk
Department for Anesthesiology and Intensive Care Medicine, University Medical Center Schleswig-Holstein, Kiel, Schleswig-Holstein, Germany
Department for Anesthesiology and Intensive Care Medicine, University Medical Center Schleswig-Holstein, Kiel, Schleswig-Holstein, Germany.
BMJ Open. 2025 May 30;15(5):e089450. doi: 10.1136/bmjopen-2024-089450.
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 SpO-target range (93-96%).
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, FiO 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 FiO, 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.
The precise control of FiO 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.
The study protocol was approved by the ethics committee of the Christian-Albrechts-University Kiel, Germany, on 17 May 2023.
DRKS00032113.
一种名为LeoClac的用于控制吸入氧分数的新型自动化系统已应用于机械通气机。该系统使用一个单独的传感器来测量外周血氧饱和度，该传感器直接连接到通气机。我们假设在使重症且接受机械通气的患者维持在SpO₂目标范围（93%-96%）方面，LeoClac将优于手动控制。
这是一项随机对照、单中心优效性研究，有两个平行组，包括40例患者。在重症监护病房（ICU）接受机械通气治疗的患者将进行资格筛查，并在获得书面知情同意后纳入研究。干预组患者将采用LeoClac进行治疗。对照组中，FiO₂将由重症监护团队手动控制。该研究的主要终点是随机分组后最初24小时内外周血氧饱和度处于目标区域的时间比例。次要终点包括高氧和低氧分析、FiO₂的变化次数、自动系统的自我终止和手动 override的次数及原因、低氧性呼吸衰竭和急性高碳酸血症性呼吸衰竭患者亚组中外周血氧饱和度处于目标区域的时间比例。此外，还将分析28天时的无通气天数和ICU死亡率。
在机械通气这个高技术领域，精确控制FiO₂以避免高氧和低氧是一项基本挑战。纳入患者异质性、减少手动干预的益处以及优化治疗结果的潜力凸显了本研究的重要性。通过解决成人精确氧控制的复杂性，本研究有助于重症监护实践的进步，并可能改善患者预后。
该研究方案于2023年5月17日获得德国基尔基督教-阿尔布雷希茨大学伦理委员会批准。
DRKS00032113。
