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. For healthy lung, PEMVECC proposed the SpO2\>95% when breathing a FiO2 of 21%. 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. This study aims to compare the closed-loop FiO2 controller with conventional control of FiO2 during mechanical ventilation of pediatric patients
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
30
Close-loop FiO2 controller software option provides automated adjustment of the ventilator Oxygen setting to maintain the patient's SpO2 in a defined target range. When using the software option, the user defines the SpO2 target range, as well as the SpO2 emergency limits, and the device adjusts the FiO2 setting to keep the patient's SpO2 in the target range.
Conventional FiO2 adjustment by the clinician according to SpO2 values, by using the manual FiO2 knob.
Aydin Obstetric and pediatrics Hospital
Aydin, Turkey (Türkiye)
Erzurum Regional Research and Training Hospital
Erzurum, Turkey (Türkiye)
Cam Sakura Research and Training Hospital
Istanbul, Turkey (Türkiye)
The Health Sciences University Izmir Behçet Uz Child Health and Diseases Research and Training Hospital
Izmir, Turkey (Türkiye)
Percentage of time spent in optimal SpO2 range
The optimal SpO2 range will be defined according to the SpO2 targets determined by the clinician.
Time frame: 2 hours
Percentage of time spent in suboptimal SpO2 range
SpO2 values outside the optimal range but still within an acceptable limit (2-3 percent above and below the optimal range)
Time frame: 2 hours
Mean FiO2
Mean fraction of inspired oxygen
Time frame: 2 hours
Mean SpO2/FiO2
Mean SpO2/FiO2
Time frame: 2 hours
Number of manual adjustments
Frequency of manual adjustments of FiO2
Time frame: 2 hours
Number of alarms
Frequency of alarms
Time frame: 2 hours
Percentage of time with SpO2 signal available
Time with SpO2 signal available
Time frame: 2 hours
Percentage of time with SpO2 below 88 and 85 percent
Duration of time with SpO2 \<85 percent and \<88 percent, respectively
Time frame: 2 hours
Number of events with SpO2 below 88 and 85 percent
Frequency of SpO2 decreases \<85 percent and \<88 percent, respectively
Time frame: 2 hours
Percentage of time with FiO2 below 40 percent, 60 percent and 100 percent
Percentage of time that FiO2 is \<40 percent, 60 percent and 100 percent, respectively
Time frame: 2 hours
Total oxygen use
Volume of total oxygen used (in L)
Time frame: 2 hours
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