NCT04568642

Comparing Closed-loop FiO2 Controller With Conventional Control of FiO2

Randomized Crossover Trial to Compare Closed-loop FiO2 Controller With Conventional Control of FiO2 During Mechanical Ventilation of Pediatric Patients

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Dr. Behcet Uz Children's Hospital · Academic / Other
• Sex: All
• Age: 1 Month – 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Acute Respiratory Failure
• Acute Hypoxemic Respiratory Failure
• Acute Hypoxemic and Hypercapnic Respiratory Failure

Interventions

Type	Name	Description
DEVICE	Activate FiO2 controller	Closed-loop FiO2 controller will be activated in the experimental arm
DEVICE	Deactivate FiO2 controller	Closed-loop FiO2 controller will be deactivated in the experimental arm

Timeline

• Start date: 2020-10-01
• Primary completion: 2022-04-01
• Completion: 2022-04-30
• First posted: 2020-09-29
• Last updated: 2023-01-31

Locations

1 site across 1 country: Turkey (Türkiye)