Closed-loop FiO2 Controller During High Flow Oxygen Treatment In Pediatric Patients (COFICOHFOT)

Study Overview
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Brief Summary
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Recently, high flow oxygen therapy (HFOT) is becoming more popular in the treatment of any kind of respiratory failure. Pediatric mechanical ventilation consensus conference (PEMVECC) guidelines suggest measuring oxygen saturation by pulse oximetry (SpO2) in all ventilated children and furthermore to measure partial arterial oxygen pressure (PaO2) in moderate-to-severe disease in order to prevent excessive use of oxygen while preventing hypoxemia and hyperoxemia. This study aims to compare the safety and efficacy of a closed-loop FiO2 controller (CLOC) with conventional control of FiO2 during HFOT of pediatric patients in a pediatric intensive care unit (PICU). The hypothesis of this study is: Close-loop FiO2 controller increases the time spent within clinically targeted SpO2 ranges and decreases the time spent outside clinical target SpO2 ranges as compared to manual oxygen control in PICU patients treated with HFOT.

Official Title
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Randomized Crossover Trial To Compare Closed-loop FiO2 Controller With Conventional Control of FiO2 During High Flow Oxygen Treatment In Pediatric Intensive Care Unit Patients

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 HFOT 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), or invasive mechanical ventilation (IMV) 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 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>Two hours period where the FiO2 delivered will be conventionally adjusted by the healthcare personnel based on SpO2 values obtained from the patient. | Device: Conventional<br>* Conventional FiO2 adjustment by the clinician according to SpO2 values<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 sub-optimal 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 oxygen | 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 | 

 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),, oxygen, Closed-loop