Introduction: We aimed to compare automated ventilation with closed–loop control of the fraction of inspired oxygen (FiO₂) to automated ventilation with manual titrations of the FiO₂ with respect to time spent in predefined pulse oximetry (SpO₂) zones in pediatric critically ill patients.Methods: This was a randomized crossover clinical trial comparing Adaptive Support Ventilation (ASV) 1.1 with use of a closed–loop FiO₂ system vs. ASV 1.1 with manual FiO₂ titrations. The primary endpoint was the percentage of time spent in optimal SpO₂ zones. Secondary endpoints included the percentage of time spent in acceptable, suboptimal and unacceptable SpO₂ zones, and the total number of FiO₂ changes per patient.Results: We included 30 children with a median age of 21 (11–48) months; 12 (40%) children had pediatric ARDS. The percentage of time spent in optimal SpO₂ zones increased with use of the closed–loop FiO₂ controller vs. manual oxygen control [96.1 (93.7–98.6) vs. 78.4 (51.3–94.8); P < 0.001]. The percentage of time spent in acceptable, suboptimal and unacceptable zones decreased. Findings were similar with the use of closed-loop FiO₂ controller compared to manual titration in patients with ARDS [95.9 (81.6–98.8) vs. 78 (49.5–94.8) %; P = 0.027]. The total number of closed-loop FiO₂ changes per patient was 52 (11.8–67), vs. the number of manual changes 1 (0–2), (P < 0.001).Conclusion: In this randomized crossover trial in pediatric critically ill patients under invasive ventilation with ASV, use of a closed–loop control of FiO₂ titration increased the percentage of time spent within in optimal SpO₂ zones, and increased the total number of FiO₂ changes per patient.Clinical trial registration: ClinicalTrials.gov, identifier: NCT04568642.

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 SpO₂ranges (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 SpO₂range 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 FiO₂was lower [33⋅3% (IQR 26⋅6–44⋅6%) vs. 42⋅6% (IQR 33⋅6–49⋅9%);P= 0.07], but median SpO₂/FiO₂was 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 [NCT 05032365].

Background: The aim of this study is the evaluation of a closed-loop oxygen control system in pediatric patients undergoing invasive mechanical ventilation (IMV).Methods: 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' 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).

Central line-associated bloodstream infection is one of the four primary health-care-associated infections applicable to pediatric intensive care units defined by The Centers for Disease Control and Prevention. According to current guidelines, it is essential to flush vascular access devices before each infusion to assess catheter function and prevent catheter-related complications. This prospective trial aimed to assess the potential differences between pre-filled and manually prepared saline syringe use during vascular access device management in a pediatric intensive care unit. Volunteered registered pediatric intensive care unit nurses were asked to implement the flushing solution to an extension line of a central venous catheter in vitro. After the randomization process with opaque sealed envelopes, they have started either with manual preparation or used sterile pre-filled saline syringes. Sterile application steps forms were used for monitoring the manual preparation of saline syringes versus the pre-filled saline syringes phase. Each volunteer repeated the steps for 3, 5, and 10 mL syringe volumes with the manually prepared and pre-filled saline syringes. After completing the procedures, failed steps and durations were transferred into a database to be analyzed by a blinded investigator. A total of 41 nurses volunteered and 123 forms for three attempts per one nurse were filled for each group. In the manual preparation group, the number of at least one failure in the necessary steps was 89 (72.3%) and the same number in the pre-filled syringe group was 6 (4.9%), and significantly lower in the pre-filled saline syringe group (p < 0.001). The overall time for preparing to flush was 86.0 ± 22.3 s (ranging from 46 to 173 s) for manual prepared syringes and 35.2 ± 9.4 s (ranging from 18 to 100 s) (p < 0.001) for pre-filled saline syringes. Our results demonstrate that the risk for breaking the aseptic no-touch technic was higher in the manual preparation group. We have also demonstrated that the flushing time was shorter with pre-filled syringes compared to manually prepared ones, which may contribute to decreasing the workload of the nurses and may increase the quality of care in the intensive care units. The use of pre-filled saline syringes may decrease the central line-associated bloodstream infections incidence and may increase the quality of care by saving extra time in the pediatric intensive care unit.