Automatic Oxygen Administration During the Respiratory Distress in Infants and Children (Infant-FreeO2)

Study Overview
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Brief Summary
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The aim of the study is to assess the use feasibility of the FreeO2 system so as to deliver automatically oxygen in infants and children admitted at hospital for hypoxemic acute respiratory distress. In healthy volunteers adults, FreeO2 system provided a better control of the oxygen saturation in function of designed target, reducing the desaturation time and hyperoxia. Our hypothesis is that FreeO2 system use is feasible in infants and children with hypoxemic acute respiratory distress. We think FreeO2 will provide a better control of the oxygen saturation, a faster oxygen weaning than classical way (Rotameter). In addition, FreeO2 could reduce the number of intervention by nurses.

Official Title
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Automatic Oxygen Administration in Spontaneous Ventilation During the Hypoxemic Acute Respiratory Distress in Infants and Children

Conditions
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Infant Between 1 Month and 24 Months Old, Hypoxemic Acute Respiratory Distress, Child Between 2 and 15 Years Old

Intervention / Treatment
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* Device: FreeO2 v2.0 automatic adjustment
* Device: FreeO2 v2.0 data collecting


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Admission to the emergency for respiratory disease justifying an oxygen administration to maintain a SpO2 ≥ 92%. inclusion within a time less than 24 hours after the start of the oxygen at the emergency department. written consent of the parents of the child Exclusion Criteria: Necessity of an oxygen flow exceeds 4 L / min to maintain a SpO2 higher than 92% Criteria of gravity justifying immediately a different technique of ventilatory support: Disturbance of consciousness with a Glasgow Coma Score ≤ 12 Hemodynamic instability (MBP < - 2 DS or need for vasopressors) Cardiac or respiratory arrest pH < 7.35 and PaCO2 > 55 mm Hg Necessity of a urgent surgery Age < 1 month Respiratory rate > 80 b/min (1 month-2 years old), > 40 b/min (2 - 10 years old) > 30b/min (> 10 years old) ou < 10 b/min

Ages Eligible for Study
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Minimum Age: 1 Month
Maximum Age: 15 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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental: device FreeO.<br>Automatic adjustment of oxygen | Device: FreeO2 v2.0 automatic adjustment<br> <br> * Other names: FreeO2 device in mode medical data collecting(SpO2).;|
| Active Comparator: Manual oxygenation<br>Manual adjustment of oxygen | Device: FreeO2 v2.0 data collecting<br> <br> * Other names: Only FreeO2 device in mode medical data collecting(SpO2);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of time spent in the target zone of oxygen saturation in the acute phase of treatment | The target zone of oxygen saturation is : SpO2 = 92-98% The acute phase of treatment is defined by the 6 first hours of treatment by oxygenation and/or until one hour after the end of this last. | 6 hours or 1 hour after cessation of oxygenation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time spent in a area of severe desaturation (SpO2 <92%) and a hyperoxia area (SpO2> 98%). |  | 6 hours or 1 hour after after cessation of oxygenation | 
| nursing workload assessed by the number of manual Oxygen flow adjustments and airway management procedures |  | 6 hours or 1 hour after oxygenation cessation | 
| Oxygen consumption measured at the end of administration |  | 6 hours or 1 hour after cessation of the oxygenation | 
| Number of complications related to the administration of oxygen |  | 28 days max | 
| Frequency of use of invasive or noninvasive ventilation during hospitalization |  | 28 days max | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hypoxemic, Respiratory distress, infant