Comparing Closed-loop FiO2 Controller With Conventional Control of FiO2
Condition: Acute Respiratory Failure; Acute Hypoxemic Respiratory Failure; Acute Hypoxemic and Hypercapnic Respiratory Failure
MeSH terms: Respiratory Insufficiency
Study type: Interventional

Summary: 
      During mechanical ventilation (MV) hypoxemic or hyperoxemic events should be carefully
      monitored and a quick response should be provided by the caregiver at the bedside. Pediatric
      mechanical ventilation consensus conference (PEMVECC) guidelines suggest to measure SpO2 in
      all ventilated children and furthermore to measure partial arterial oxygen pressure (PaO2) in
      moderate-to-severe disease. There were no predefined upper and lower limits for oxygenation
      in pediatric guidelines, however, Pediatric acute lung injury consensus conference PALICC
      guidelines proposed SpO2 between 92 - 97% when positive end-expiratory pressure (PEEP) is
      smaller than 10 cm H2O and SpO2 of 88 - 92% when PEEP is bigger or equal to 10 cm H2O. [1]
      For healthy lung, PEMVECC proposed the SpO2>95% when breathing a FiO2 of 21%.[2] As a rule of
      thumb, the minimum fraction of inspired O2 (FiO2) to reach these targets should be used. A
      recent Meta-analyze showed that automated FiO2 adjustment provides a significant improvement
      of time in target saturations, reduces periods of hyperoxia, and severe hypoxia in preterm
      infants on positive pressure respiratory support. [3] This study aims to compare the
      closed-loop FiO2 controller with conventional control of FiO2 during mechanical ventilation
      of pediatric patients
    

Detailed description: 
      The study has a crossover design. Patients will start in standard ASV 1.1 settings, then
      attending physician will assess the ventilation parameters according to study protocol and
      will note them in the case report form as he starts the data recording with MemoryBox (MB)in
      the mixed mode. Afterwards, the clinician will start the first phase by either keeping the
      patient in ASV 1.1 without any closed-loop controllers activated or switching to ASV 1.1 with
      only FiO2 controller activated according to the randomization. After 2.5 hours of recording
      in the first phase, the clinician will switch the patient to the second phase regarding
      randomization order. If the patient was ventilated without FiO2 controller activated in the
      first phase, the controller will be activated in the second phase. The patient will stay in
      the second phase for 2.5 hours as well. The first 0.5 hours of the first phase will be
      considered as run-in phase and the first 0.5 hours of the second phase will be considered as
      wash-out phase. Therefore the first 0.5 hours of each phase will be excluded from data
      analysis due to cross-over study design.
    

Intervention name(s): Activate FiO2 controller; Deactivate FiO2 controller
Intervention type(s): Device; Device
Intervention description(s): Closed-loop FiO2 controller will be activated in the experimental arm; Closed-loop FiO2 controller will be deactivated in the experimental arm
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Acute respiratory failure (ARF); Pediatric acute respiratory distress syndrome (PARDS),; Acute lung injury (ALI),; SpO2; FiO2