Automatic Oxygen Administration During the Respiratory Distress in Infants and Children (Infant-FreeO2) (Infant-Free02)

Regional University Hospital Center (CHRU)

Status: Completed

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

Treatments: Device: FreeO2 v2.0 automatic adjustment; Device: FreeO2 v2.0 data collecting

Study type: Interventional

Funder types: Other

Identifiers

NCT02302183

Infant-FreeO2

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Ages: 1 month to 15 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Experimental: device FreeO.

Experimental group

Description:

Automatic adjustment of oxygen

Treatment:

Device: FreeO2 v2.0 automatic adjustment

Manual oxygenation

Active Comparator group

Description:

Manual adjustment of oxygen

Treatment:

Device: FreeO2 v2.0 data collecting