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

University Hospital, Brest60 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

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

Eligibility

Sex: ALLMin age: 1 MonthMax age: 15 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: 6 hours or 1 hour after cessation of oxygenation

Secondary Outcomes

Time spent in a area of severe desaturation (SpO2 <92%) and a hyperoxia area (SpO2> 98%).

Time frame: 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

Time frame: 6 hours or 1 hour after oxygenation cessation

Oxygen consumption measured at the end of administration

Time frame: 6 hours or 1 hour after cessation of the oxygenation

Number of complications related to the administration of oxygen

Time frame: 28 days max

Frequency of use of invasive or noninvasive ventilation during hospitalization