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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental: device FreeO. | Experimental | Automatic adjustment of oxygen |
|
| Manual oxygenation | Active Comparator | Manual adjustment of oxygen |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FreeO2 v2.0 automatic adjustment | Device |
|
|
| 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 |
| 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 |
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Inclusion Criteria:
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:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHRU de Brest | Brest | 29609 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32827344 | Derived | Roue JM, Delpeut J, d'Hennezel A, Tierrie T, Barzic A, L'Her E, Cros P. Automatic oxygen flow titration in spontaneously breathing children: An open-label randomized controlled pilot study. Pediatr Pulmonol. 2020 Nov;55(11):3180-3188. doi: 10.1002/ppul.25035. Epub 2020 Aug 31. |
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| FreeO2 v2.0 data collecting | Device |
|
|
| 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 |
| ID | Term |
|---|---|
| D004417 | Dyspnea |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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