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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-12-24

Study Completion Date

2017-02-23

Brief Summary

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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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Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Experimental: device FreeO.

Automatic adjustment of oxygen

Group Type EXPERIMENTAL

FreeO2 v2.0 automatic adjustment

Intervention Type DEVICE

Manual oxygenation

Manual adjustment of oxygen

Group Type ACTIVE_COMPARATOR

FreeO2 v2.0 data collecting

Intervention Type DEVICE

Interventions

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FreeO2 v2.0 automatic adjustment

Intervention Type DEVICE

FreeO2 v2.0 data collecting

Intervention Type DEVICE

Other Intervention Names

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Automatic adjustment of oxygen through the "Free O2" device. "FreeO2" device in mode medical data collecting(SpO2). Manual adjustment of oxygen without the assistance of the "FreeO2" device. Only "FreeO2" device in mode medical data collecting(SpO2)

Eligibility Criteria

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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

Minimum Eligible Age

1 Month

Maximum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No