Clinical trial NCT02302183: Automatic Oxygen Administration During the Respiratory Distress in Infants and Children (Infant-FreeO2)
Official title: Automatic Oxygen Administration in Spontaneous Ventilation During the Hypoxemic Acute Respiratory Distress in Infants and Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypoxemic Acute Respiratory Distress
Infant Between 1 Month and 24 Months Old
Child Between 2 and 15 Years Old
Keywords: Hypoxemic, Respiratory distress, infant
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2014-11-26
Enrollment: 60
Sex: ALL
Minimum age (years): 1
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Percentage of time spent in the target zone of oxygen saturation in the acute phase of treatment
timeFrame: 6 hours or 1 hour after cessation of oxygenation
Secondary outcomes:
measure: Time spent in a area of severe desaturation (SpO2 <92%) and a hyperoxia area (SpO2> 98%).
timeFrame: 6 hours or 1 hour after after cessation of oxygenation
measure: nursing workload assessed by the number of manual Oxygen flow adjustments and airway management procedures
timeFrame: 6 hours or 1 hour after oxygenation cessation
measure: Oxygen consumption measured at the end of administration
timeFrame: 6 hours or 1 hour after cessation of the oxygenation
measure: Number of complications related to the administration of oxygen
timeFrame: 28 days max
measure: Frequency of use of invasive or noninvasive ventilation during hospitalization
timeFrame: 28 days max
Other outcomes:
Locations:
city: Brest
country: France
facility: CHRU de Brest
Study officials:
References:
citation: 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.