Closed-Loop O2 Use During Invasive Mechanical Ventilation of Pediatric Patients (CLOUDIMPP): A Randomized Cross-Over Study

Abstract

Abstract Oxygen is an effective treatment for any type of respiratory failure. To prevent hypoxemia and hyperoxemia, the Pediatric mechanical ventilation consensus conference (PEMVECC) recommends monitoring oxygen saturation with pulse oximetry (SpO2) in all ventilated children and measuring partial arterial oxygen pressure (PaO2) in moderate to severe cases. However, this may require manual adjustments of inspired oxygen, which can be burdensome during high-demand periods such as the current COVID-19 epidemic. Additionally, the pandemic has highlighted the importance of optimizing oxygen use in hospitals as it may become a scarce resource during such high-demand periods. Previous studies have shown that automatic oxygen titration (AOT) is feasible in patients receiving respiratory support therapy, including those with mild acute hypoxemic respiratory failure and exercise-induced desaturation. This study aims to assess the safety and efficacy of a closed-loop FiO2 controller in comparison to traditional manual FiO2 regulation during invasive mechanical ventilation (IMV) in pediatric patients within a pediatric critical care unit (PICU). The hypothesis is that the closed-loop FiO2 controller will increase the time spent within clinically intended SpO2 ranges and decrease the time spent outside these ranges. The research is registered under NCT05714527