Atakul Gulhan, Ceylan Gokhan, Sandal Ozlem, Soydan Ekin, Hepduman Pinar, Colak Mustafa, Zimmermann Jan M, Novotni Dominik, Karaarslan Utku, Topal Sevgi, Aǧin Hasan
Department of Paediatric Intensive Care Unit, Dr Behcet Uz Children's Disease and Surgery Training and Research Hospital, Health Sciences University, Izmir, Türkiye.
Department of Medical Research, Hamilton Medical AG, Chur, Switzerland.
Front Med (Lausanne). 2024 Sep 10;11:1426969. doi: 10.3389/fmed.2024.1426969. eCollection 2024.
The aim of this study is the evaluation of a closed-loop oxygen control system in pediatric patients undergoing invasive mechanical ventilation (IMV).
Cross-over, multicenter, randomized, single-blind clinical trial. Patients between the ages of 1 month and 18 years who were undergoing IMV therapy for acute hypoxemic respiratory failure (AHRF) were assigned at random to either begin with a 2-hour period of closed-loop oxygen control or manual oxygen titrations. By using closed-loop oxygen control, the patients' SpO levels were maintained within a predetermined target range by the automated adjustment of the FiO. During the manual oxygen titration phase of the trial, healthcare professionals at the bedside made manual changes to the FiO, while maintaining the same target range for SpO. Following either period, the patient transitioned to the alternative therapy. The outcomes were the percentage of time spent in predefined SpO ranges ±2% (primary), FiO, total oxygen use, and the number of manual adjustments.
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 SpO 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%]; < 0.001). Median FiO was lower (32.1% [IQR 23.9-54.1%] vs. 40.6% [IQR 31.1-62.8%]; < 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]; < 0.001); however, median SpO/FiO was higher (329.4 [IQR 180-411.1] vs. 246.7 [IQR 151.1-320.5]; < 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]; < 0.001).
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.
This research has been submitted to ClinicalTrials.gov (NCT05714527).
本研究旨在评估在接受有创机械通气（IMV）的儿科患者中闭环氧控制系统的效果。
交叉、多中心、随机、单盲临床试验。将年龄在1个月至18岁之间因急性低氧性呼吸衰竭（AHRF）接受IMV治疗的患者随机分配，要么先进行2小时的闭环氧控制，要么先进行手动氧滴定。通过使用闭环氧控制，通过自动调整吸入氧浓度（FiO₂）将患者的血氧饱和度（SpO₂）水平维持在预定目标范围内。在试验的手动氧滴定阶段，床边的医护人员手动调整FiO₂，同时维持SpO₂的相同目标范围。在任一阶段之后，患者转换为另一种治疗方法。结局指标包括在预定义的SpO₂范围±2%内的时间百分比（主要指标）、FiO₂、总氧用量以及手动调整次数。
纳入的33例患者的中位年龄为17（13 - 55.5）个月。与手动氧滴定相比，启用闭环氧控制器时患者在预定义的最佳SpO₂范围内花费的时间比例更高（95.7%[四分位间距92.1 - 100%]对65.6%[四分位间距41.6 - 82.5%]），平均差异33.4%[95%置信区间24.5 - 42%]；P < 0.001）。中位FiO₂较低（32.1%[四分位间距23.9 - 54.1%]对40.6%[四分位间距31.1 - 62.8%]；P < 0.001），总氧用量也类似（19.8升/小时[四分位间距4.6 - 64.8]对39.4升/小时[四分位间距16,8 - 79]；P < 0.001）；然而，采用闭环氧控制时，中位SpO₂/FiO₂更高（329.4[四分位间距180 - 411.1]对246.7[四分位间距151.1 - 320.5]；P < 0.001）。采用闭环氧控制时，手动调整的中位次数减少（0.0[四分位间距0.0 - 0.0]对1[四分位间距0.0 - 2.2]；P < 0.001）。
闭环氧控制可改善因AHRF接受IMV的儿科患者的氧疗效果，可能会提高氧的利用效率。该技术还减少了手动调整的必要性，这可能会减轻医护人员的工作量。
本研究已提交至ClinicalTrials.gov（NCT05714527）。
