Closed-Loop O2 Use During Invasive Mechanical Ventilation Of Pediatric Patients

Study Overview
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Brief Summary
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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

Official Title
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Closed-Loop O2 Use During Invasive Mechanical Ventilation Of Pediatric Patients (CLOUDIMPP)- a Randomized Cross-over Study

Conditions
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Respiratory Failure

Intervention / Treatment
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* Device: Close-loop FiO2 controller
* Device: Conventional


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pediatric patients older than 1 month and younger than18 years of age; hospitalized at the PICU with the intention of treatment with IMV at least for the upcoming 5 hours Requiring FiO2 ≥ 25% to keep SpO2 in the target ranges defined by the clinician Written informed consent signed and dated by the patient or one relative in case that the patient is unable to consent, after full explanation of the study by the investigator and prior to study participation Exclusion Criteria: Patient with indication for immediate noninvasive ventilation (NIMV), High flow oxygen therapy (HFOT) Hemodynamic instability defined as a need of continuous infusion of epinephrine or norepinephrine > 1 mg/h Low quality on the SpO2 measurement using finger and ear sensor (quality index below 60% on the SpO2 sensor, which is displayed by a red or orange colour bar) Severe acidosis (pH ≤ 7.25) Pregnant woman Patients deemed at high risk for the need of non-invasive mechanical ventilation within the next 5 hours Patients deemed at high risk for the need of transportation from PICU to another ward, diagnostic unit or any other hospital Diseases or conditions which may affect transcutaneous SpO2 measurement such as chronic or acute dyshemoglobinemia: methemoglobinemia, carbon monoxide (CO) poisoning, sickle cell disease Formalized ethical decision to withhold or withdraw life support Patient included in another interventional research study under consent Patient already enrolled in the present study in a previous episode of acute respiratory failure

Ages Eligible for Study
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Minimum Age: 1 Month
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Close-loop FiO2 Controller<br>Two hours period where the fraction of inspired oxygen (FiO2) delivered will be automatically titrated based on SpO2 values obtained from the patient. | Device: Close-loop FiO2 controller<br>* 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.<br>|
| Active Comparator: Conventional<br>Conventional FiO2 adjustment by the clinician according to SpO2 values | Device: Conventional<br>* Conventional FiO2 adjustment by the clinician according to SpO2 values, by using the manual FiO2 knob.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of time spent in optimal SpO2 range | The optimal SpO2 range will be defined according to the SpO2 targets determined by the clinician. | 2 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 2 hours | 
| Mean FiO2 | Mean fraction of inspired oxygen | 2 hours | 
| Mean SpO2/FiO2 | Mean SpO2/FiO2 | 2 hours | 
| Number of manual adjustments | Frequency of manual adjustments of FiO2 | 2 hours | 
| Number of alarms | Frequency of alarms | 2 hours | 
| Percentage of time with SpO2 signal available | Time with SpO2 signal available | 2 hours | 
| Percentage of time with SpO2 below 88 and 85 percent | Duration of time with SpO2 <85 percent and <88 percent, respectively | 2 hours | 
| Number of events with SpO2 below 88 and 85 percent | Frequency of SpO2 decreases <85 percent and <88 percent, respectively | 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 | 2 hours | 
| Total oxygen use | Volume of total oxygen used (in L) | 2 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acute respiratory failure (ARF), Pediatric acute respiratory distress syndrome (PARDS), Closed-loop, Oxygen, SpO2