Child Between 2 and 15 Years Old, Hypoxemic Acute Respiratory Distress, Infant Between 1 Month and 24 Months Old
Conditions
Keywords
Hypoxemic, Respiratory distress, infant
Brief summary
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.
Interventions
DEVICEFreeO2 v2.0 automatic adjustment
DEVICEFreeO2 v2.0 data collecting
Sponsors
University Hospital, Brest
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Months to 15 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of time spent in the target zone of oxygen saturation in the acute phase of treatment | 6 hours or 1 hour after cessation of oxygenation | 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. |
Secondary
| Measure | 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 |
Countries
France
Outcome results
None listed