Automation Oxygen Flow Titration in Spontaneously Breathing Infants

Study Overview
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Brief Summary
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The objective of this study is to assess the efficacy of the FreeO2 device in shortening the hospital length of stay during a first episode of hypoxemic bronchiolitis in infants less than 1 year of age. FreeO2Bronchio study is a multicenter, prospective, controlled, randomized, open-label study.

Detailed Description
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This is a controlled, randomized, open-label, multicentre trial. Patients will be included after written informed consent will be obtained from the patients' parents or legally authorized representatives. Patients will be randomized either in the FreeO2 group for automatic oxygen flow titration or in the manual group for Oxygen therapy with manual flow titration. The SpO2 will be recorded continuously in both groups of the study using the FreeO2 device throughout the duration of hospitalization; In the group FreeO2 , the device will record the data continuously and allow the automation of oxygen titration - in the group Manual, the device will only be used to monitor SpO2 and heart rate.

Official Title
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Automation Oxygen Flow Titration in Spontaneously Breathing Infants Less Than One Year of Age During a First Episode of Bronchiolitis

Conditions
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Bronchiolitis

Intervention / Treatment
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* Device: FreeO2 (modèle FO2-220-00) automatic oxygen flow titration
* Device: FreeO2 (modèle FO2-220-00) manual oxygen flow titration


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Infants from 1 month of age and less than 1 year of age who present a first episode of bronchiolitis and require oxygen therapy Informed consent of parents (written informed consent will be obtained from the patients' parents or legally authorized representatives) Affiliation to the French social security system Exclusion Criteria: Need for oxygen flow higher than 3 L / min to maintain SpO2 greater than 92% Patient with severity criteria according to the 2019 French National Authority for Health (HAS) guidelines and for whom it's indicated to maintain SpO2 above 94% Criteria of severity justifying from the start another technique of assisted ventilation: Polypnea: respiratory rate (FR)> 80 c / min. Consciousness with glasgow score (GSC) <or = 12. Hemodynamic instability (mean arterial pressure (MAP) <- 2 SD for age or use of vasopressors). Cardiac or respiratory arrest. PCO2> 55 mm Hg and pH <7.20 when blood gas are performed Need for urgent surgery Contraindication to the FreeO2 device as described in the user manual Lack of informed consent from parents Premature birth with a gestational age at birth under 36 weeks Severe co-morbidities (cystic fibrosis, immune deficiency, congenital heart disease, neuromuscular illness)

Ages Eligible for Study
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Minimum Age: 1 Month
Maximum Age: 1 Year

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: Parallel Assignment
Interventional Model Description: This is a multicenter, prospective, controlled, randomized, open-label study. Patients will be randomized to either the FreeO2 group for automatic oxygen titration or the manual group for oxygen therapy using manual flow titration.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FreeO2 group<br>Automatic oxygen flow titration | Device: FreeO2 (modèle FO2-220-00) automatic oxygen flow titration<br>* Automatic adjustment of oxygen flow titration through the FreeO2 device. The monitor allows continuous monitoring and recording of SpO2 and Heart rate<br>|
| Active Comparator: Manual group<br>Manual oxygen flow titration | Device: FreeO2 (modèle FO2-220-00) manual oxygen flow titration<br>* Manual oxygen flow titration performed by the healthcare provider in charge of the patient (nurse, physician). For this group, the FreeO2 device will only monitor and record SpO2 and heart rate.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of hospital stay in hours since the admission to the emergency room. | The length of hospital stay in hours since admission in the emergency room will be compared between the two groups. | 30 days max | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients readmited to hospital within 7 days and 30 days following discharge |  | 30 days max | 
| Number of patients needing assisted ventilation (invasive or noninvasive ) |  | 30 days max | 
| Number of patient admitted to the intensive care unit within 3 days following the hospital admission |  | 30 days max | 
| Duration of enteral feeding (hours) |  | 30 days max | 
| Duration of intravenous hydration (hours) |  | 30 days max | 
| Number of reported Adverse Events |  | 30 days max | 
| Time spent in the a area of severe desaturation (SpO2 <92%) and of hyperoxia area (SpO2> 98%). |  | 30 days max | 
| Number of patients needing Heated Humidified High Flow Nasal Cannula (HFNNC) |  | 30 days max | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hypoxemia, Infants, Oxygen therapy, Bronchiolitis